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Revision of Articular Surface Replacement (ASR) Total Hip Arthroplasty: Correlation of Perioperative Data and Early Post-Revision Outcome Results
Revision of Articular Surface Replacement (ASR TM ) Total Hip Arthroplasty: Correlation of Perioperative Data and Early Post-Revision Outcome Results Johannes Cip MD, Christian Bach MD, Mark Widemschek MD, Matthias Luegmair MD, MSc, Arno Martin MD, MSc PII: DOI: Reference:
S0883-5403(15)00275-2 doi: 10.1016/j.arth.2015.04.010 YARTH 54421
To appear in:
Journal of Arthroplasty
Received date: Revised date: Accepted date:
29 December 2014 24 March 2015 6 April 2015
Please cite this article as: Cip Johannes, Bach Christian, Widemschek Mark, Luegmair Matthias, Martin Arno, Revision of Articular Surface Replacement (ASRTM ) Total Hip Arthroplasty: Correlation of Perioperative Data and Early Post-Revision Outcome Results, Journal of Arthroplasty (2015), doi: 10.1016/j.arth.2015.04.010
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ACCEPTED MANUSCRIPT Revision of Articular Surface Replacement (ASR™) Total Hip Arthroplasty: Correlation of Perioperative Data and Early Post-Revision Outcome Results
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Johannes Cip MD, Christian Bach Assoc. Prof., MD, Mag, Mark Widemschek MD, Matthias Luegmair MD, MSc, Arno Martin Assoc. Prof., MD, MSc
Department of Orthopedic Surgery, Academic Teaching Hospital Feldkirch,
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Medical University of Innsbruck, Carinagasse 47, A-6800 Feldkirch, Austria Email: [email protected]; [email protected]; [email protected];
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[email protected]; [email protected]
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One author JC, CB, MW, ML, AM or any member of his or her immediate family, has no funding or commercial associations (eg, consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with
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the submitted article.
This work was performed at Department of Orthopedic Surgery, Academic Teaching Hospital Feldkirch, Medical University of Innsbruck, Austria and approved by the ethics
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commission. All authors have participated in research. The article is not submitted elsewhere. It is a new manuscript submission.
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Please address all correspondence to:
Johannes Cip [MD] () Department of Orthopedic Surgery, Academic Teaching Hospital, Medical University of Innsbruck, Carinagasse 47, A-6800 Feldkirch, Austria Phone: 0043/5522/303-1605 Fax: 0043/5522/303-7520 email: [email protected]
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ACCEPTED MANUSCRIPT Revision of Articular Surface Replacement (ASR™) Total Hip Arthroplasty: Correlation of Perioperative Data and Early Post-Revision Outcome Results
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Abstract
The Articular Surface Replacement (ASR) total hip arthroplasty (THA) showed accelerated failure rates due to adverse-reaction to metal debris (ARMD). Literature correlating
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preoperative data with intraoperative revision findings is rare. No post-revision outcome
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results are published yet. 30 of 99 available ASR THA were revised due to ARMD. Mean post-revision follow-up term was 2.3 ±0.5 years. In part, preoperative data did not correlate
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with intraoperative revision findings. ARMD was even found in asymptomatic patients with non-elevated ion levels. Postoperative pain and metal ion levels decreased significantly
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(p≤0.016). Cobalt decreased faster than Chrome. Patients with intraoperative pseudotumors, osteolysis or bilateral ASR THA did not have higher pre- or postoperative ion values (p≥0.053). Females showed higher postoperative Chrome levels (p=0.031). One major post-
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occurred.
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revision complication (femoral nerve palsy) and one re-revision (late onset infection)
Keywords: Articular Surface Replacement, ASR, Total Hip Arthroplasty, Revision, Outcome
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ACCEPTED MANUSCRIPT Introduction Large diameter metal-on-metal (MOM) bearings for total hip arthroplasty (THA) were
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developed due to proclaimed advantages of decreased wear rates in comparison to polyethylene-on-metal bearings, a lower hip dislocation rate, lower implant fracture risks in comparison to ceramic-on-ceramic bearings, a higher range of motion (ROM) in comparison
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to small headed THA and the opportunity to produce resurfacing hip arthroplasties.[1–7] However, after introducing the Articular Surface Replacement (ASR™) XL THA (DePuy
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Orthopaedics, Inc., Warsaw, IN, USA) accelerated failure rates after short in-situ time were
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found worldwide.[7–14] Langton et al. reported a failure rate of 6% after 41 months and 48.8% after 6 years.[9,10] The National Joint Registry of England and Wales postulated failure rates of 13% after 5 years.[8] Steele at al. published a revision rate of 12% after 1.6
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years.[7] Reito et al. proclaimed a 7 year survivorship of 38% for small headed ASR™ THA.[15] Bernthal et al. reported implant dysfunction in 28.6% with a revision rate of 17.1% after 3 years.[12] This results were comparable to our previously published data verifying a
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revision rate of 24.5% after a mean follow-up term of 3.5 years, mostly due to adverse
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reaction to metal debris (ARMD).[14] ARMD was introduced as umbrella term subsuming metallosis with elevated blood ion levels, soft-tissue lesions and/or pseudotumors, aseptic lymphocytic vasculitis-associated lesions (ALVAL) and implant failure associated with groin pain.[9,11,16,17] However, despite accelerated failure rates of the ASR™ THA were reported several times, to the best of our knowledge, there is a paucity of literature correlating preoperative clinical, radiological and metal ion data with intraoperative revision findings.[9,18,19] Available studies are restricted by a retrospective study design[18] or a limited number of revised ASR™ THA (n ≤ 18)[9,18,19]. Additionally, no fundamental post-revision follow-up data is published yet. Stryker et al.[20] reported a high early complication rate of 20% 14 months after revision of a heterogeneous group of metal-on-metal THA. Matharu et al.[21] had a re3
ACCEPTED MANUSCRIPT revision rate of 12.5% after 4.5 years. Munro et al.[22] reported a higher rate of major complications in at least 38% 25 months after revision of 31 Durom® MOM articulations and
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one ASR™ THA. They reported a decrease of Chrome (Cr) and Cobalt (Co) metal ion levels in 14 of 16 patients after revision surgery.[22] Randelli et al.[19] postulated significant higher ion values for patients with failed ASR™ THA with severe intraoperative acetabular bone
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loss. However, to the best of our knowledge, there is no literature available yet reporting on post-revision follow-up data and blood metal ion levels after explantation of all ASR™ THA
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devices.
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Hence, because we had verified a revision rate of at least 24.5% after 3.5 years [14], preoperative, intraoperative and postoperative data of all patients who underwent revision surgery due to ARMD was analyzed. The main study aims were to find out whether (1)
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preoperative collected data (clinical and radiological results; blood metal ions) do correlate with intraoperative revision findings; (2) blood ion levels significantly decrease after removing of all ASR™ devices, (3) pseudotumors or intraoperativ osteolysis, gender or a
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bilateral implanted ASR™ THA affect pre- and post-revision blood metal ions, (4) and to
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report minimum one year follow-up results after revision surgery.
Materials and Methods At our institution we had implanted 99 ASR™ THA in 88 patients between December 2005 and April 2009. 11 patients received an ASR™ THA on bilateral side. A high early revision rate of this patient cohort was already reported previously.[14] For primary implantation, the ASR™ femoral head was combined with a CoxaFit stem (K-Implant, Hannover, Germany) in 97 of 99 prosthesis, in two cases an ARGE Geradschaft stem (K-Implant, Hannover, Germany) was used. Both stems had a common 12/14 mm taper.[14] 78 implants were performed through a minimal-invasive anterolateral approach.[23] In 21 cases a lateral transgluteal approach was used for primary implantation.[24] 4
ACCEPTED MANUSCRIPT However, by the beginning of January 2014, 31 (31.3%) of 99 ASR™ THA were revised. 30 ASR™ THA (30.3%) were revised due to ARMD. One ASR™ THA was revised due to a late
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onset infection and excluded for this analysis. No other complications with need of revision surgery occurred after primary ASR™ THA. Indication for revision surgery was decided using the guidelines published by the British Hip Society.[25] All revisions were performed
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between 19.07.2010 and 29.11.2013. Mean time to revision surgery after primary implantation was 4.6 ±0.9 (2.7 – 6.7) years. Revision surgery was performed through a
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conventional lateral approach.[24] Müller back plates or Zintra acetabular screw cups
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(Zimmer, Warsaw, Inc., USA) combined with a high molecular weight polyethylene were used for acetabular revision. Loosened femoral stems were replaced with a Zweymueller revision stem. The ASR™ femoral head was removed and a conventional 28 or 32 mm
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femoral head (K-Implant, Hannover, Germany) was implanted. Overall, we were able to revise 28 of 30 ASR™ THA at our institution. Two patients underwent revision surgery in a different hospital. Hence, no intraoperative data was available. All patients gave informed
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consent before they were included in this review board approved study.
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Pre-revision data included baseline characteristics (gender, age, body mass index, ASA Classification[26], side of implantation, surgical approach, size of implanted components) of all patients at time of primary ASR™ THA. (Table 1) Accordingly, clinical and radiological data obtained shortly before revision surgery was analyzed. This data was collected 4.4 ±1.0 [2.5 – 6.6] years after primary ASR™ THA. Clinical parameters included range of motion (ROM), trochanteric pain, push & pull sign and gluteal muscle weakness (Trendelenburg sign). Radiological investigation was performed with conventional hip X-rays taken 3 months after primary ASR™ THA and shortly before revision surgery in anterior-posterior (ap), axial and pelvic view. Acetabular cup inclination angle was measured in frontal plane on pelvic overview by one orthopedic surgeon.[14] A high inter- and intraobserver reliability was already described previously.[27] Osteolytic loosening zones around the acetabular cup and 5
ACCEPTED MANUSCRIPT femoral stem in anterior-posterior and axial view were obtained.[28–31] (Table 2, Figure 1AC) Computer tomography (CT) imaging was performed to detect soft tissue lesions,
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pseudotumors, component loosening and osteolysis. In three cases no CT-scan was available: one patient refused imaging and in two cases no CT was performed due to acetabular cup loosening, which was already diagnosed by conventional X-rays.
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During ASR™ revision surgery we obtained appearance of pseudotumors/soft-tissue lesions, intraarticular effusion, metallosis, osteolysis/cystic bone lesions and loosening of acetabular
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cup or the femoral stem. Intraoperative findings were compared and correlated to preoperative
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clinical, radiological and metal ion data. We were interested whether clinical and radiological data respectively serum ion levels collected before revision surgery do correlate with intraoperative revision findings.
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At least one year after ASR™ revision surgery, patients underwent postoperative clinical and radiological follow-up. Examination included same clinical and radiological parameters as before revision surgery. No computer-tomography imaging was performed. We were able to
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compare pre- with postoperative revision data in 20 of 30 ASR™ THA. 5 patients were lost to
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follow-up: 2 patients had died unrelated to revision surgery; 3 patients were not reached. An additional of 5 patients had been excluded for postoperative clinical data analysis because they were investigated within 12 months after revision surgery. Mean follow-up was 2.3 ±0.5 (1.5 – 3.1) years after ASR™ THA revision surgery. (Figure 2) Chrome and Cobalt levels in serum were collected regularly before and after revision surgery. We were interested whether and how serum ion levels would decrease after explantation of all ASR™ devices. Blood was collected with a 21-gauge venofix butterfly system (B.Braun, Melsungen, Germany) or a 21-gauge multi drawing needle (Greiner Bio-one, Frickenhausen, Germany). Vacuette native tubes or tubes filled with ethylendiamintetraacetate (EDTA) respectively heparine were used to collect blood samples. Accordingly blood samples were diluted with 1:19 diluent (1g/L K-EDTA + 0.25% NH4OH in highly cleaned water) and 6
ACCEPTED MANUSCRIPT analyzed by X-SERIES 2 ICP mass spectrometry (ThermoFisher, Dreieich, Germany). Measuring range was set at 1 to 300 μg/L for Chrome and 1 to 400 μg/L for Cobalt. Serum
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ion levels of more than 7 μg/L were considered as elevated.[25] For statistical analysis we compared highest ion levels measured before revision surgery with the lowest ion levels collected after ASR™ THA revision. To avoid adulteration of ion data, all bilateral ASR™
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THA cases (n = 5) were excluded for statistical analysis. Hence, 20 patients (20 ASR™ THA) were available to compare pre- with postoperative ion levels. (Figure 2) Maximum ion levels
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were measured 48.8 ±11.8 (5.7 – 61.1) months after primary and 5.5 ±6.3 (0 – 28) months
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before ASR™ revision surgery. Minimum ion values were obtained 23.9 ±10.6 (1.6 – 35.2) months after ASR™ revision surgery. However, we did a separate statistical ion analysis comparing pre- and postoperative metal ion levels of unilateral (n = 20) with bilateral (n = 5)
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ASR™ THA. For bilateral cases maximum ion levels were measured 51.8 ±5.6 (45 – 59) months after primary and 11.5 ±8.5 (3 – 24) months before ASR™ revision surgery.
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Minimum ion values were obtained 19.6 ±13.7 (6 – 35) months after ASR™ revision surgery.
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For statistical analysis SPSS Software Version 18 (Chicago, Illinois, USA) was used. For every parameter mean, standard deviation, minimum and maximum values were calculated. For blood ion levels the median value was also analyzed. Significance was set at p < 0.05. Kolmogorov-Smirnov test was used to assume normal distribution. Normal distributed dependent data was compared using paired t-test. Dependent categorical and nominal data was analyzed using Sign and McNemar test, respectively. Independent categorical and nominal data was compared using Fisher`s exact test or Chi-Square test. For independent nonnormal distributed skewed data Mann-Whitney U-Test was used. For comparison of more than two independent groups the Kruskal-Wallis test was performed.
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ACCEPTED MANUSCRIPT Results In part, preoperative collected data did not correlate with intraoperative revision findings. CT
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imaging revealed soft tissue lesions/pseudotumors in 12 (44.4%) of 27 available ASR™ THA. However, in 2 cases no typical pseudotumor was found during revision surgery. Both patients had increased ion levels and showed local metallosis with osteolysis. In 4 cases a
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pseudotumor was found intraoperatively, but not described by CT imaging. 9 ASR™ THA (33.3%) showed acetabular cup and/or femoral stem loosening with CT imaging. However,
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intraoperatively in 3 cases all components were well fixed to the bone without loosening. All
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of these patients suffered from severe pain (VRS = 4), showed highly increased blood ion values and/or intraoperative pseudotumors with metallosis. In 3 cases acetabular loosening was found intraoperatively but not described by preoperative CT.
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X-rays taken shortly before revision surgery revealed acetabular cup loosening in 6 ASR™ THA. Two femoral stems showed accelerated radiological radiolucency in ap and axial view. This was confirmed by CT imaging and even found during revision surgery. Remaining x-
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rays did not show any osteolysis or component loosing. Intraoperative findings showed 5
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cases with solid cystic bone lesions, 6 hips with accelerated osteolysis and 9 loosened acetabular cups. All femoral stems except of two were well fixed to the bone. Intraarticular effusion was revealed in at least 17 cases during surgery. In 19 cases metallosis/black stained soft tissue was found. However, only in 5 cases stained hip aspirate was found preoperatively. Finally, there were 5 patients with non-elevated ion levels < 7 μg/L. Though, pseudotumors were found in 3 cases, metallosis was revealed in 4 patients and two acetabular cups respectively one femoral stem showed aseptic loosening during revision surgery. (Table 3; adapted Table, Cip et al.[14]) Comparison of pre- with postoperative blood ion levels showed a significant decrease for both Chrome and Cobalt (p < 0.001) in all patients. (Figure 3) Every patient showed lower ion values after ASR™ THA revision surgery than before. Delta ion parameters (highest 8
ACCEPTED MANUSCRIPT preoperative minus lowest postoperative ion value) revealed a faster decrease for Cobalt than for Chrome in all evaluations. (Table 4; Figure 4)
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There were no statistical significant differences within preoperative or postoperative Chrome or Cobalt values or delta ion values when comparing groups of intraoperative pseudotumor (yes vs. no), intraoperative osteolysis (yes vs. no), intraoperative component loosening (yes
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vs. no), gender (female vs. male) or unilateral versus bilateral ASR™ THA (p ≥ 0.053). Only females showed significant higher postoperative Chrome levels than male patients did (p =
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0.031) based no a higher mean preoperative Chrome level, which was not statistically
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significant (p = 0.181).
Overall, one major post-revision complication occurred by the end of this trial: One patient showed immediate postoperative femoral nerve palsy due to a nerve traction injury. In
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addition one re-revision was performed due to a late onset infection 8 months after initial revision surgery, which included a polyethylene-inlay and femoral head change. Remaining revision procedures showed no major complications (e.g. infection, aseptic loosening,
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periprosthetic fracture, nerve injuries) or need of a re-revision surgery at a mean follow-up
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term of 2.3 ±0.5 (1.5 – 3.1) years after initial revision procedure. By the end of this trial there was even no hip dislocation in the whole study cohort. Compared to pre-revision data we found a significant decreased postoperative pain intensity level (p = 0.016). However, 2 patients suffered still from severe pain (VRS = 4) and five patients claimed about moderate pain (VRS = 3). The postoperative HSS was not significant different (p = 0.650). No significant differences were revealed when comparing pre- with postoperative ROM (p ≥ 0.101). However, a higher mean abduction was revealed at least one year postoperatively (p = 0.045). (Table 5) Additionally, also those five patients, who were investigated within one year after revision surgery and excluded for clinical statistical analysis, improved with a postoperative VRS of 1.8 ±0.8 (1 – 3) and HHS of 90.4 ±10.4 (72 – 97).
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ACCEPTED MANUSCRIPT Discussion After introducing ASR™ THA accelerated failure rates after short term were reported
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worldwide.[7–14] Soft-tissue lesions, pseudotumors, component loosening, metallosis, elevated blood ion levels, ALVAL and accelerated groin pain were found and described as ARMD.[9,11,16,17] ARMD was reported as main reason for early ASR™ THA
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failure.[14,15]
However, so far there are only few articles reporting on metal-on-metal intraoperative
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revision findings.[9,18,19] Available studies are restricted by a retrospective study design or a
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limited number of ASR™ THA revised due to ARMD (n ≤18).[9,18,19] Additionally, to the best of our knowledge, there is no post-revision data published yet, dealing with patients who underwent ASR™ THA revision surgery. Several authors are reporting on a high early post-
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revision complication rate of 20% or more after revision of several different metal-on-metal THA. [20,22] Munro et al.[22] published a decrease of Chrome and Cobalt levels in 14 of 16 patients after revision surgery. However, nothing is known whether and how fast elevated
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blood ion levels decrease after explantation of ASR™ THA. No recent post-revision follow-
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up data is published yet. Because we had revised 30 ASR™ THA devices due to ARMD, we are reporting on pre-, intra- and post-revision clinical, radiological and metal ion data. The study was restricted by several limitations. First, baseline characteristics and pre-revision data was collected retrospectively. Nevertheless, we had a complete follow-up rate for all parameters. Only in two cases we were not able to obtain the preoperative HHS. Intraoperative and postoperative data was collected prospectively. Second, 5 patients were lost to postoperative follow-up. An additional of 5 patients were excluded due to a minimum one year follow-up after revision surgery. We think that a minimum post-revision follow-up term of at least one year was necessary to avoid adulteration of postoperative clinical data. A short follow-up term may had influenced ROM, HHS and VRS results. However, all of those
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ACCEPTED MANUSCRIPT patients improved clinically already after short follow-up term and were also included for metal ion analysis.
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There were discrepancies between preoperative CT imaging and intraoperative revision findings. Metal artifacts led to a reduced imaging quality and affected interpretations of CT scans. In 4 patients an intraoperative pseudotumor/soft tissue lesion was not found by
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preoperative imaging. Kwon et al.[32] already described metal artifact reduction sequence (MARS) magnet resonance imaging (MRI) as an important cross-sectional imaging to detect
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ARMD around metal-on-metal implants. In a previous analysis, we already reported lower
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rates of soft tissue lesions when using CT imaging in comparison to literature using MARSMRI.[14] A lower sensitivity for CT scan may explain these discrepancies.[14] Additionally, we had three patients where osteolysis was found intraoperatively but not seen with
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preoperative CT-scan. Randelli et al.[19] also described unexpected intraoperative osteolysis when using MRI and plain radiographs for preoperative imaging. The authors described in detail a reduced ability to detect osteolysis around metal-on-metal bearings, especially in
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presence of local metallosis.[19] CT imaging may be superior to detect osteolysis and
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component loosening around metal-on-metal bearings in comparison to MARS MRI. In addition CT is less time consuming, mostly easy available and cheaper than MARS MRI. However, based on our discrepancies between preoperative imaging results and intraoperative revision findings, MARS MRI and even ultrasound imaging should be used as golden standard to detect even smaller soft tissue lesions and/or intraarticular effusion around MOM bearings. Nawabi et al.[33] reported MRI as a sensitive and specific tool in detecting soft tissue damage in patients with an implanted metal-on-metal hip. Intraarticular effusion was found in most of our revision procedures. However, only five cases revealed a stained preoperative hip aspiration. Small amount of intraarticular effusion may be difficult to aspirate. Ultrasound imaging is time consuming and investigator depended, but cheap and an established tool without radiation exposure. Hence, this technique could be used to detect 11
ACCEPTED MANUSCRIPT even small amounts of intraarticular effusion around MOM bearings, which may be an important initial sign of ARMD. Elevated ion levels were considered to be predictive for
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ARMD and local metallosis.[14,34] However, five patients had ion levels within a threshold that was considered as “low risk” in recently published guidelines.[32] We found pseudotumors, metallosis and aseptic component loosening when serum ion levels were less
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than 7 μg/L respectively 2 μg/L. Consequently, low ion values do not exclude ARMD. Similar findings were reported previously.[35] In addition, also a pain free and asymptomatic
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hip may have ARMD. We had asymptomatic patients where elevated ion levels,
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intraoperative pseudotumors and metallosis was found. A close clinical and radiological follow-up is recommended even in asymptomatic patients with low ion levels. Unspecific or mild symptoms of groin pain could be a first sign of ARMD.
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Corrosion along the surface of the femoral stem or at MOM modular junctions was described as one leading cause of elevated metal ions.[11,36] For ASR™ THA increased wear was not only described on the articulation surface but also at the trunnion-taper interface, the
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connection between the femoral stem and head.[10] However, because we did not find any
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severe trunnion damage, we left the well fixed femoral stem in at least all patients except in 2 cases, where the femoral stem was loosened. Nevertheless, after explantation of all ASR™ devices, serum ion levels decreased significantly in all patients, even after a short follow-up term. This results confirm that the ASR™ THA devices were the main source of blood metal ions. Hence, we recommend not to revise a well fixed femoral stem unnecessarily if there is no severe macroscopic trunnion damage. Matthies et al.[37] already reported a negligible volume of material loss at the male taper of the femoral stem in comparison to the female taper of the femoral head or the articular bearing surface. Cobalt and Chrome are excreted by the kidney.[38,39] However, our results verified that Cobalt values decreased faster than those for Chrome. This may be related to a different excretion pathway. Keegan et al.[39] described that Cobalt is rapidly excreted by the kidney 12
ACCEPTED MANUSCRIPT whereas Chrome is concentrated in the epithelial cells of the proximal renal tubules. This may explain a slower excretion and serum level decrease of Chrome. Hence, if patients show
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highly elevated ion values, especially Chrome levels may be elevated for years after revision surgery. There is still no consensus whether and at which threshold blood metal ions are toxic for patients with metal-on-metal arthroplasties. Not only local tissue reactions but also
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systemic side effects with cardio toxicity, neurotoxicity, terratogenic or cancerogenic effects were described previously.[39] Hence, we recommend a close clinical follow-up, measuring
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metal ions regularly, even when all ASR™ THA devices are removed.
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Randelli et al.[19] reported that patients with severe intraoperative acetabular bone loss were associated with significant higher serum ion levels. We could not confirm significant differences within patients with or without intraoperative osteolysis, pseudotumors or
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component loosening regarding pre- or postoperative ion values. There was also no difference within unilateral versus bilateral ASR™ THA. The relatively small number of bilateral cases may account for this findings. However, this results were in accordance to data published by
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De Smet et al.[40]. Females had significant higher postoperative Chrome values compared to
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the male cohort (p = 0.031). Even preoperatively Chrome was nearly twice as much for female patients in comparison to male patients. Higher metal ion values with a higher risk for ARMD for female patients due to differences in acetabular cup version angles or femoral head diameter was reported in literature several times.[15,16,41] All evaluations revealed a significant decrease of metal ions after revision surgery. This is comparable to the results published by Munro et al.[22]. Stryker et al.[20] reported a high early complication rate of 20% after revision of a heterogeneous group of metal-on-metal THA. Munro et al.[22] published major complications in at least 38% after revision of 31 Durom® MOM articulations and one ASR™ THA. In our study cohort we had one immediate major post-revision complication including a femoral nerve palsy. No re-revision procedure was necessary in this case. However, one re-revision 13
ACCEPTED MANUSCRIPT surgery was performed due to a late onset infection 8 months later, which can not be related to the initial revision procedure. The discrepancies within our satisfying post-revision results and
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the high complication rate reported previously[20,22] may be related to their extremely high early hip dislocation [22] or aseptic loosening rate [20,22]. A posterior approach used by Munro et al.[22] combined with different implants compared to the current study may had
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resulted in a higher rate of instability and consequently in a higher hip dislocation rate.[42] Additionally, a direct comparison to previous study results [20,22] is difficult due to a
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heterogeneous patient cohort including several different MOM implants, patients with
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variable degrees of osteolysis or soft-tissue lesions and different post-revision follow-up terms.
To summarize, patients even with an already revised ASR™ THA must undergo close clinical
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follow-up including regular metal ion measurement. A pain free hip or normal ion levels do not exclude ARMD. CT is a useful and fast screening tool to detect component loosening, osteolysis or soft tissue lesions. Inconspicuous imaging does not exclude ARMD. MARS
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MRI may be superior to detect soft tissue lesions. We recommend establishing ultrasound
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imaging in screening patients with metal-on-metal hip implants. An intraarticular effusion may be an initial sign for ARMD. Revision of ASR™ THA reduces blood ion levels significantly. We think that revision of a well-fixed femoral stem without any severe macroscopic trunnion damage is not necessary. In our study cohort acceptable early postrevision results were obtained. Surgeons should follow previous published guidelines to indicate revision surgery sufficiently early to end up in satisfying short-term post-revision results.
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ACCEPTED MANUSCRIPT Literature Amstutz HC, Le Duff MJ, Beaulé PE. Prevention and treatment of dislocation after total hip replacement using large diameter balls. Clin Orthop Relat Res 2004:108–16.
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Anissian HL, Stark A, Gustafson A, Good V, Clarke IC. Metal-on-metal bearing in hip prosthesis generates 100-fold less wear debris than metal-on-polyethylene. Acta Orthop Scand 1999;70:578–82.
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Cohen D. Out of joint: the story of the ASR. BMJ 2011;342:d2905.
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Cuckler JM, Moore KD, Lombardi A V, McPherson E, Emerson R. Large versus small femoral heads in metal-on-metal total hip arthroplasty. J Arthroplasty 2004;19:41–4.
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Lombardi A V, Skeels MD, Berend KR, Adams JB, Franchi OJ. Do large heads enhance stability and restore native anatomy in primary total hip arthroplasty? Clin Orthop Relat Res 2011;469:1547–53.
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Sikes C Van, Lai LP, Schreiber M, Mont MA, Jinnah RH, Seyler TM. Instability after total hip arthroplasty: treatment with large femoral heads vs constrained liners. J Arthroplasty 2008;23:59–63.
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Steele GD, Fehring TK, Odum SM, Dennos AC, Nadaud MC. Early failure of articular surface replacement XL total hip arthroplasty. J Arthroplasty 2011;26:14–8.
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De Steiger RN, Hang JR, Miller LN, Graves SE, Davidson DC. Five-year results of the ASR XL Acetabular System and the ASR Hip Resurfacing System: an analysis from the Australian Orthopaedic Association National Joint Replacement Registry. J Bone Joint Surg Am 2011;93:2287–93.
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Langton DJ, Jameson SS, Joyce TJ, Hallab NJ, Natu S, Nargol AVF. Early failure of metal-on-metal bearings in hip resurfacing and large-diameter total hip replacement: A consequence of excess wear. J Bone Joint Surg Br 2010;92:38–46.
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[10] Langton DJ, Jameson SS, Joyce TJ, Gandhi JN, Sidaginamale R, Mereddy P, et al. Accelerating failure rate of the ASR total hip replacement. J Bone Joint Surg Br 2011;93:1011–6. [11] Bolland BJRF, Culliford DJ, Langton DJ, Millington JPS, Arden NK, Latham JM. High failure rates with a large-diameter hybrid metal-on-metal total hip replacement: clinical, radiological and retrieval analysis. J Bone Joint Surg Br 2011;93:608–15. [12] Bernthal NM, Celestre PC, Stavrakis AI, Ludington JC, Oakes DA. Disappointing short-term results with the DePuy ASR XL metal-on-metal total hip arthroplasty. J Arthroplasty 2012;27:539–44. [13] Smith AJ, Dieppe P, Vernon K, Porter M, Blom AW. Failure rates of stemmed metalon-metal hip replacements: analysis of data from the National Joint Registry of England and Wales. Lancet 2012;379:1199–204.
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ACCEPTED MANUSCRIPT [14] Cip J, von Strempel A, Bach C, Luegmair M, Benesch T, Martin A. Implication of Femoral Stem on Performance of Articular Surface Replacement (ASR) XL Total Hip Arthroplasty. J Arthroplasty 2014.
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[15] Reito A, Puolakka T, Elo P, Pajamäki J, Eskelinen A. High prevalence of adverse reactions to metal debris in small-headed ASR™ hips. Clin Orthop Relat Res 2013;471:2954–61. [16] Haddad FS, Thakrar RR, Hart AJ, Skinner JA, Nargol AVF, Nolan JF, et al. Metal-onmetal bearings: the evidence so far. J Bone Joint Surg Br 2011;93:572–9.
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[17] Willert H-G, Buchhorn GH, Fayyazi A, Flury R, Windler M, Köster G, et al. Metal-onmetal bearings and hypersensitivity in patients with artificial hip joints. A clinical and histomorphological study. J Bone Joint Surg Am 2005;87:28–36.
MA
[18] Hug KT, Watters TS, Vail TP, Bolognesi MP. The withdrawn ASR™ THA and hip resurfacing systems: how have our patients fared over 1 to 6 years? Clin Orthop Relat Res 2013;471:430–8.
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[19] Randelli F, Banci L, Favilla S, Maglione D, Aliprandi A. Radiographically undetectable periprosthetic osteolysis with ASR implants: the implication of blood metal ions. J Arthroplasty 2013;28:1259–64. [20] Stryker LS, Odum SM, Fehring TK, Springer BD. Revisions of Monoblock Metal-onmetal THAs Have High Early Complication Rates. Clin Orthop Relat Res 2014.
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[21] Matharu GS, Pynsent PB, Sumathi VP, Mittal S, Buckley CD, Dunlop DJ, et al. Predictors of time to revision and clinical outcomes following revision of metal-onmetal hip replacements for adverse reaction to metal debris. Bone Joint J 2014;96B:1600–9.
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[22] Munro JT, Masri BA, Duncan CP, Garbuz DS. High complication rate after revision of large-head metal-on-metal total hip arthroplasty. Clin Orthop Relat Res 2014;472:523– 8. [23] Bertin KC, Röttinger H. Anterolateral mini-incision hip replacement surgery: a modified Watson-Jones approach. Clin Orthop Relat Res 2004:248–55. [24] Bauer R, Kerschbaumer F, Poisel S, Oberthaler W. The transgluteal approach to the hip joint. Arch Orthop Trauma Surg 1979;95:47–9. [25] Association BO. Withdrawal of DePuy ASR Resurfacing and XL Metal on Metal Bearings - Information for and Advice to Surgeons from the British Hip Society and the British Orthopaedic Association. Online 2010. [26] Little JP. Consistency of ASA grading. Anaesthesia 1995;50:658–9. [27] Patel SR, Toms AP, Rehman JM, Wimhurst J. A reliability study of measurement tools available on standard picture archiving and communication system workstations for the evaluation of hip radiographs following arthroplasty. J Bone Joint Surg Am 2011;93:1712–9. 16
ACCEPTED MANUSCRIPT [28] Gruen TA, McNeice GM, Amstutz HC. “Modes of failure” of cemented stem-type femoral components: a radiographic analysis of loosening. Clin Orthop Relat Res 1979:17–27.
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[29] DeLee JG, Charnley J. Radiological demarcation of cemented sockets in total hip replacement. Clin Orthop Relat Res:20–32. [30] Charnley J. Total prosthetic replacement of the hip. Reconstr Surg Traumatol 1969;11:9–19.
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[31] Johnston RC, Fitzgerald RH, Harris WH, Poss R, Müller ME, Sledge CB. Clinical and radiographic evaluation of total hip replacement. A standard system of terminology for reporting results. J Bone Joint Surg Am 1990;72:161–8.
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[32] Kwon Y-M, Lombardi A V, Jacobs JJ, Fehring TK, Lewis CG, Cabanela ME. Risk stratification algorithm for management of patients with metal-on-metal hip arthroplasty: consensus statement of the American Association of Hip and Knee Surgeons, the American Academy of Orthopaedic Surgeons, and the Hip Society. J Bone Joint Surg Am 2014;96:e4.
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[33] Nawabi DH, Gold S, Lyman S, Fields K, Padgett DE, Potter HG. MRI predicts ALVAL and tissue damage in metal-on-metal hip arthroplasty. Clin Orthop Relat Res 2014;472:471–81.
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[34] Chang EY, McAnally JL, Van Horne JR, Van Horne JG, Wolfson T, Gamst A, et al. Relationship of plasma metal ions and clinical and imaging findings in patients with ASR XL metal-on-metal total hip replacements. J Bone Joint Surg Am 2013;95:2015– 20.
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[35] Macnair RD, Wynn-Jones H, Wimhurst JA, Toms A, Cahir J. Metal ion levels not sufficient as a screening measure for adverse reactions in metal-on-metal hip arthroplasties. J Arthroplasty 2013;28:78–83. [36] Jacobs JJ, Cooper HJ, Urban RM, Wixson RL, Della Valle CJ. What do we know about taper corrosion in total hip arthroplasty? J Arthroplasty 2014;29:668–9. [37] Matthies AK, Racasan R, Bills P, Blunt L, Cro S, Panagiotidou A, et al. Material loss at the taper junction of retrieved large head metal-on-metal total hip replacements. J Orthop Res 2013;31:1677–85. [38] Corradi M, Daniel J, Ziaee H, Alinovi R, Mutti A, McMinn DJW. Early markers of nephrotoxicity in patients with metal-on-metal hip arthroplasty. Clin Orthop Relat Res 2011;469:1651–9. [39] Keegan GM, Learmonth ID, Case CP. Orthopaedic metals and their potential toxicity in the arthroplasty patient: A review of current knowledge and future strategies. J Bone Joint Surg Br 2007;89:567–73. [40] De Smet K, De Haan R, Calistri A, Campbell PA, Ebramzadeh E, Pattyn C, et al. Metal ion measurement as a diagnostic tool to identify problems with metal-on-metal hip resurfacing. J Bone Joint Surg Am 2008;90 Suppl 4:202–8. 17
ACCEPTED MANUSCRIPT [41] De Haan R, Pattyn C, Gill HS, Murray DW, Campbell PA, De Smet K. Correlation between inclination of the acetabular component and metal ion levels in metal-onmetal hip resurfacing replacement. J Bone Joint Surg Br 2008;90:1291–7.
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[42] Kwon MS, Kuskowski M, Mulhall KJ, Macaulay W, Brown TE, Saleh KJ. Does surgical approach affect total hip arthroplasty dislocation rates? Clin Orthop Relat Res 2006;447:34–8.
18
ACCEPTED MANUSCRIPT Table 1: Demographic data of all 30 ASR™ THA (at primary implantation) Parameter Gender (n) 14
Men
16
Patient age (years)
49.6 ± 8.5 (21-61)
Body mass index (kg/cm²)
27.7 ± 3.7 (19-47)
SC
RI PT
Women
I
18
II
NU
ASA Classification (n)
12
III - V
0
MA
Side of implantation (n) Left
Surgical approach (n)
PT ED
Right
21 9
26
Conventional lateral approach
4
Size of acetabular component (mm)
53.6 ± 5.6 (44-64)
Size of femoral head (mm)
47.5 ± 4.7 (39-57)
Size of implanted conus (mm)
3.7 ± 2.2 (2 - 8)
Size of implanted stem (mm) ASA = American Society of Anesthesiologists
12.6 ± 2.3 (10-18)
AC
CE
Minimal invasive anterolateral approach
19
ACCEPTED MANUSCRIPT
Table 2: Clinical and Radiological data shortly before ASR™ revision surgery (n = 30 ASR™ THA) Radiological Parameter
Range of motion (ROM)
Acetabular loosening zones in anterior-posterior view (n)
PT
Clinical Parameter
101.3 ± 14.6 (70 - 130)
Zone I
Abduction
31.9 ± 11.7 (10 - 60)
Zone II
Adduction
27.4 ± 8.7 (10 - 45)
Zone III
Internal rotation
21.3 ± 8.7 (5 - 40)
Femoral loosening zones in anterior-posterior view (n)
External rotation
23.5 ± 11.4 (5 - 50)
Zone I
2 x 2 mm
MA NU SC
RI
Flexion
1 x 1 mm 1 x 1 mm 1 x 1 mm
Zone II
1 x 1 mm; 2 x 2 mm
Positive
3
Zone VI
2 x 1 mm
Negative
21
Zone VII
1 x 2 mm
push & pull sign (n)
Trochanteric pain (n)
Femoral loosening zones in lateral view (n) 7
Zone VIII
1 x 8 mm
Negative
14
Zone IX
1 x 5 mm
Zone XIII
2 x 1 mm
Zone XIV
1 x 1 mm
ED
Positive
Positive
1
Negative
17
PT
Trendelenburg sign (n)
CE
Verbal Rating Scale (n)
Acetabular inclination angle shortly after primary ASR™ implantation [1] (°)
45.5 ± 8.3 (34 - 77)
Inclination angle more than 50° (n)
7
Inclination angle 50° or less (n)
23
Inclination angle more than 45° (n)
11
3
Mild pain (2)
5
Moderate pain (3)
12
Severe pain (4)
8
Very severe pain (5)
2
Worst possible pain (6)
0
Inclination angle within 40 - 45° (n)
13
VRS overall
3.0 ± 1.1 (1 - 5)
Inclination angle below 40° (n)
6
Harris Hip Score (before primary implantation)
55.7 ± 16.0 (24 - 87)
Shortly before ASR™ revision surgery [2] (°)
47.3 ± 10.8 (34 - 76)
Harris Hip Score (6 weeks after implantation)
90.8 ± 8.7 (62 - 100)
Relative difference within inclination angle [1] and [2] (°)
1.8 ± 5.6 (-5 - 16)
Absolute difference within inclination angle [1] and [2] (°)
3.6 ± 4.6 (0 - 16)
AC
No pain (1)
81.9 ± 14.9 (52 - 100) Harris Hip Score (shortly before revision surgery) Values are presented as mean ± standard deviation (minimum - maximum)
20
ACCEPTED MANUSCRIPT
Scores (prerevision )
Blood Ion Level
Intraoperati ve Findings
Acetabula r inclinatio n angle (prerevision)
Radiology
No .
Reason for revision
Revision (years)
Gender
Acetabula r cup size
HH S
VR S
Acetabular inclination angle (shortly after implantatio n)
Differenc e
CT: Component loosening
1
ARMD: Ion elevation
6,6
female
50
45
98
1
42
40
2
-
-
2
ARMD: Ion elevation, metallosis
5,0
female
50
45
96
2
77
76
1
#
#
3
ARMD: Ion elevation, pseudotumor
5,0
male
56
49
65
3
44
45
1
4
ARMD: Component loosening, metallosis
4,0
female
52
46
93
3
43
59
16
5
ARMD: Increased pain levels, metallosis
4,8
male
58
51
96
3
34
35
1
6
ARMD: Ion elevation, pseudotumor
4,9
female
50
45
96
2
35
34
1
7
ARMD: Component loosening, pseudotumor, ion elevation
4,6
male
64
57
95
3
37
37
0
8
ARMD: High pain intensity, ion elevation, metallosis
5,0
female
46
41
71
4
39
42
3
9
ARMD: Component loosening, pseudotumor, pain, ion elevation
4,2
male
60
53
n.a.
4
51
53
2
10
ARMD: Ion elevation, metallosis
4,3
female
50
45
100
1
42
41
1
11
ARMD: Component loosening, ion elevation
2,7
male
54
47
55
3
40
40
0
12
ARMD: Component loosening, ion elevation, metallosis
4,6
male
54
47
96
2
50
49
13
ARMD: Ion elevation, highly increased acetabular inclination
4,6
female
50
45
89
2
49
64
14
ARMD: Component loosening, pseudotumor, pain
4,1
male
52
46
80
4
38
37
15
ARMD: Pseudotumor, ion elevation, metallosis
4,6
female
48
43
99
1
41
16
ARMD: Pseudotumor, ion elevation, metallosis
6,1
male
54
47
76
3
42
17
ARMD: Component loosening, ion elevation, pain
3,4
male
58
51
75
4
38
18
ARMD: Pseudotumor, ion elevation, metallosis
5,2
male
62
55
81
2
19
ARMD: High pain intensity, highly increased acetabular inclinaton
2,7
female
50
45
61
20
ARMD: Ion elevation, rising pain intensity
4,5
female
44
39
78
21
ARMD: Accelerated pain intensity level, elevated ions
5,6
female
46
41
86
22
ARMD: Steeply increased acetabular inclination, ion elevation, pain
4,4
female
48
43
n.a.
23
ARMD: Pseudotumor, ion elevation, metallosis
6,3
male
60
53
24
ARMD: Ion elevation, pseudotumor, metallosis
4,9
male
60
53
25
ARMD: Component loosening, pseudotumor, ion elevation
4,8
male
60
26
ARMD: Pain, ion elevation, pseudotumor
4,5
female
27
ARMD: component loosening, accelerated pain
4,0
28
ARMD: Accelerated pain, ion elevation
29
ARMD: Increased inclination angle, ion elevation, pain
CT: Pseudotum or
Preoperati ve Hip Aspirate with metallosis
Chrom e (µg/L)
Cobal t (µg/L )
Intraarticul ar effusion
Metallosi s
-
27,0
36,0
-
yes
yes
125,0
165,0
yes
MA NU SC
Femoral stem loosenin g
Pseudotum or
Cysti c lesion s
Osteolysi s
Acetabular component loosening
-
yes
-
-
-
yes
yes
yes
-
-
-
-
yes
-
6,9
11,0
yes
yes
yes
-
-
-
-
yes
-
-
2,0
2,0
yes
yes
yes
-
-
yes
yes
-
-
-
4,4
1,5
yes
yes
-
-
-
-
-
-
yes
-
12,0
15,0
-
-
-
-
yes
-
-
yes
yes
-
3,2
13,0
-
yes
yes
-
yes
yes
-
-
-
yes
12,0
5,2
yes
yes
-
-
-
yes
-
yes
yes
-
13,0
24,0
*** ***
-
-
9,5
14,0
-
-
1
8,5
-
-
-
-
-
yes
-
1
yes
-
-
9,8
14
yes
yes
yes
-
-
yes
-
15
-
-
-
12
18
yes
yes
-
-
-
-
-
1
yes
yes
-
1,6
1
-
yes
yes
-
-
-
yes
37
4
-
yes
yes
14
12
yes
yes
yes
-
-
-
-
42
0
-
yes
-
16
19
-
-
yes
-
yes
-
-
40
2
yes
-
-
5,1
11
yes
-
-
-
-
-
-
43
40
3
-
yes
-
4,3
12
-
yes
-
-
-
-
-
5
53
68
15
-
-
-
1,5
1,3
-
-
yes
-
-
yes
-
3
53
57
4
-
-
-
64
72
-
yes
-
-
-
-
-
3
44
44
0
-
-
-
13
6
-
-
-
-
-
-
-
5
42
~
~
~
~
-
6,6
15
yes
-
-
-
yes
yes
-
86
3
45
40
5
-
yes
-
3,6
11
-
yes
yes
yes
-
-
-
96
3
54
50
4
-
yes
yes
95
217
yes
yes
yes
yes
-
-
-
53
96
3
55
53
2
yes
yes
yes
53
50
yes
yes
yes
-
yes
-
-
46
41
52
4
49
53
4
-
yes
-
77
132
yes
-
yes
yes
-
-
-
male
62
55
62
4
42
44
2
yes
-
-
2,9
3,7
yes
yes
-
-
-
-
-
3,2
female
50
45
70
4
43
42
1
-
-
-
11
17
yes
-
-
-
-
-
-
5,4
male
56
49
61
4
51
61
10
-
-
-
7,1
4,1
yes
yes
yes
-
-
yes
-
~
~
~
~
-
62
70
yes
yes
yes
-
yes
yes
-
AC
CE
PT
-
yes
ED
30
Femor al head size
RI
Baselinecharacterisit cs
PT
Table 3: Comparison Pre-revision and Intraoperative Data
ARMD: Steeply increased acetabular inclination, ion 4,2 male 58 51 84 3 49 elevation, pain - = not found; # = CT refused; ~ = steeply increased inclination angle; n.a. = not evaluated/missing value; *** = revision performed in a different hospital, no intraoperative data available ARMD = adverse reaction to metal debris; HHS = Harris Hip Score; VRS = Verbal Rating Scale; CT = Computer tomography
21
ACCEPTED MANUSCRIPT
Table 4: Blood Ion Statistics: Comparison of pre and postoperative serum ion data (unilateral ASR ™ THA) Chrome (µg/L) (postoperative)
delta Chrome (µg/L)
p-value
Cobalt (µg/L) (preoperative)
PT
Chrome (µg/L) (preoeprative)
Parameter
Cobalt (µg/L) (postoperative)
delta Cobalt (µg/L)
p-value
36.9 ± 60.3 (0 - 216) / 13.0
< 0.001*
overall (n = 20)
23.8 ± 35.3 (1.6 – 125) / 8.3 5.1 ± 8.9 (1 - 36) / 1.5
18.7 ± 27.5 (0 - 88.9) / 6.5 < 0.001* 37.9 ± 60.3 (1 - 217) / 14.0 1.1 ± 0.2 (1 - 2) / 1.0
Gender
female (n = 8)
33.9 ± 44.0 (2 - 125) / 12.0
7.9 ± 11.8 (1 - 36) / 2.8
26.0 ± 33.3 (1 - 89) / 9.9
male (n = 12)
17.1 ± 28.2 ( 2 - 95) / 6.0
3.2 ± 6.3 (1.0 - 23) / 1.0 13.9 ± 23.1 (0 - 72) / 4.4
p-value
0.181
0.031*
0.157
yes (n = 11)
34.9 ± 44.9 (2 - 125) / 7.1
7.3 ± 11.6 (1 - 36) / 1.0
27.7 ± 34.9 (0 - 88.9) / 6.1 0.012*
56.4 ± 77.4 (1 - 217) / 13.0 1.0 ± 0.0 (1) /1.0
55.4 ± 77.4 (0 - 216) / 4.2
0.002*
no (n = 7)
10.0 ± 8.3 (3 - 27) / 6.6
2.5 ± 2.6 (1 - 8) / 1.3
7.5 ± 6.0 (2 - 19) / 4.2
14.3 ± 11.3 (2 - 36) / 15.0
1.1 ± 0.2 (1 - 2) / 1.0
13.2 ± 11.2 (1 - 34) / 14.0
0.016*
p-value
0.791
0.930
0.860
0.791
0.659
0.791
yes (n = 4)
18.7 ± 23.2 (3 - 53) / 9.0
1.8 ± 1.0 (1 - 3) / 2.0
22.3 ± 17.9 (12 - 49) / 14.0
no (n = 14)
27.1 ± 40.6 (2 - 125) / 7.0
p-value
0.878 5.1 ± 3.3 (2 - 10) / 4.9
1.2 ± 0.6 (1 - 2) / 1.0
3.8 ± 3.2 (1 - 9) / 3.2
no (n = 12)
35.3 ± 42.2 (3 - 125) / 12.0
7.5 ± 11.0 (1 - 36) / 2.6
27.8 ± 32.7 (0 - 89) / 9.9
p-value
0.053
0.067
Component looseninga yes (n = 6)
Unilateral versus Bilateral ASR™ THA
49.6 ± 62.4 (2 - 165) / 16.5 1.1 ± 0.2 (1 - 2) / 1.0
48.6 ± 62.4 (1 - 164) / 15.5
0.008*
0.006*
30.1 ± 60.3 (1 - 217) / 11.0 1.0 ± 0.1 (1 - 2) / 1.0
29.1 ± 60.3 (0 - 216) / 10.0
0.001*
0.098
0.098
ED
MA NU SC
0.008*
0.016*
0.851
0.125
23.3 ± 17.9 (13 - 50) / 15
1.0 ± 0.0 (1) / 1.0
6.5 ± 10.4 (1 - 36) / 1.2
20.7 ± 30.9 (0 - 89) / 5.4
0.002*
44.8 ± 71.2 (1 - 217) / 11
1.0 ± 0.2 (1.0 - 1.6) / 1.0 43.8 ± 71.2 (0 - 216) / 10.0
0.789
0.878
0.382
0.878
0.382
0.031*
8.2 ± 6.5 (1 - 15) / 8.6
1.0 ± 0.0 (1) / 1.0
7.2 ± 6.5 (0 - 14) / 7.6
0.063
0.006*
55.9 ± 73.2 (2 - 217) / 16.5 1.1 ± 0.2 (1 - 2) /1.0
54.9 ± 73.2 (1 - 216) / 15.5
< 0.001*
0.102
0.102
PT
16.9 ± 23.6 (2 - 52) / 6.7
CE
Osteolysisa
AC
Pseudotumora
RI
Overall
0.102
0.820
0.125 < 0.001*
unilateral (n = 20) 23.8 ± 35.3 (1.6 – 125) / 8.3 5.1 ± 8.9 (1 - 36) / 1.5
18.7 ± 27.5 (0 - 88.9) / 6.5 < 0.001* 37.9 ± 60.3 (1 - 217) / 14.0 1.1 ± 0.2 (1 - 2) / 1.0
36.9 ± 60.3 (0 - 216) / 13.0
< 0.001*
bilateral (n = 5)
19.5 ± 24.6 (3 - 63) / 10.2
0.063
22.3 ± 23.8 (4 - 64) / 14.0
2.8 ± 2.3 (1 - 6) / 1.3
0.063
p-value 0.272 0.974 0.408 * = Significant different; values are represented as mean ± standard deviation (minimum - maximum) / median value; delta = preoperative value - postoperative value; a = two patients were revised at a different hospital, no intraoperative data available
24.2 ± 27.1 (6 - 72) / 12.0
2.7 ± 2.9 (1 - 8) / 1.0
21.5 ± 27.8 (5 - 71) / 11.0
0.921
0.272
0.668
22
ACCEPTED MANUSCRIPT Table 5: Comparison of preoperative with postoperative clinical results (n = 20 ASR ™ THA) before revision
Flexion
100.5 ± 14.7 (70 - 130) 100.5 ± 12.9 (80 - 125)
0.999
Abduction
32.2 ± 12.1 (20 - 60)
40.0 ± 8.3 (25 - 50)
0.045*
Adduction
27.0 ± 9.6 (10 - 45)
27.9 ± 5.8 (15 - 40)
0.949
Internal Rotation
21.5 ± 9.6 (5 - 40)
20.3 ±10.6 (0 - 45)
0.789
External Rotation
24.1 ± 11.9 (5 - 50)
30.3 ± 8.3 (15 - 40)
0.101
Positive
3
0
0.250
Negative
11
SC
NU
Push & pull sign (n)
MA
Trochanteric pain (n) Positive
after revision
RI PT
Parameter
20
4
7
10
13
0
5
10
15
2
7
4
5
Moderate pain (3)
7
5
Severe pain (4)
6
2
Very severe pain (5)
1
0
Worst possible pain (6)
0
0
VRS overall
3.0 ± 1.1 (1 - 5)
2.1 ± 1.0 (1 - 4)
Trendelenburg sign (n) Positive Negative
CE
Verbal Rating Scale (n)
AC
No pain (1) Mild pain (2)
PT ED
Negative
p-values
85.9 ± 14.7 (52 - 100) 85.1 ± 14.7 (45 - 100) Harris Hip Score *=Significant different; values are presented as mean ± standard deviation (minimum - maximum)
0.688
0.250
0.016* 0.650
23
ACCEPTED MANUSCRIPT Figure legend Legends:
RI PT
Figure 1A-C: Loosening zone measurement around the acetabular cup in anterior-posterior view (1A) [29,30] and around the femoral stem in anterior-posterior (1B) [28] and axial (1C) view [31], respectively.
SC
Figure 2: Follow-up flowchart
NU
Figure 3: Chrome and Cobalt values of all patients pre- and post-revision surgery
AC
CE
PT ED
MA
Figure 4: Metal ion trendline pre- and post-revision surgery
24
AC
CE
PT ED
MA
NU
SC
RI PT
ACCEPTED MANUSCRIPT
Figure 1a
25
AC
CE
PT ED
MA
NU
SC
RI PT
ACCEPTED MANUSCRIPT
Figure 1b
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S0883-5403(15)00275-2 doi: 10.1016/j.arth.2015.04.010 YARTH 54421
To appear in:
Journal of Arthroplasty
Received date: Revised date: Accepted date:
29 December 2014 24 March 2015 6 April 2015
Please cite this article as: Cip Johannes, Bach Christian, Widemschek Mark, Luegmair Matthias, Martin Arno, Revision of Articular Surface Replacement (ASRTM ) Total Hip Arthroplasty: Correlation of Perioperative Data and Early Post-Revision Outcome Results, Journal of Arthroplasty (2015), doi: 10.1016/j.arth.2015.04.010
This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT Revision of Articular Surface Replacement (ASR™) Total Hip Arthroplasty: Correlation of Perioperative Data and Early Post-Revision Outcome Results
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Johannes Cip MD, Christian Bach Assoc. Prof., MD, Mag, Mark Widemschek MD, Matthias Luegmair MD, MSc, Arno Martin Assoc. Prof., MD, MSc
Department of Orthopedic Surgery, Academic Teaching Hospital Feldkirch,
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Medical University of Innsbruck, Carinagasse 47, A-6800 Feldkirch, Austria Email: [email protected]; [email protected]; [email protected];
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[email protected]; [email protected]
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One author JC, CB, MW, ML, AM or any member of his or her immediate family, has no funding or commercial associations (eg, consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with
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the submitted article.
This work was performed at Department of Orthopedic Surgery, Academic Teaching Hospital Feldkirch, Medical University of Innsbruck, Austria and approved by the ethics
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commission. All authors have participated in research. The article is not submitted elsewhere. It is a new manuscript submission.
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Please address all correspondence to:
Johannes Cip [MD] () Department of Orthopedic Surgery, Academic Teaching Hospital, Medical University of Innsbruck, Carinagasse 47, A-6800 Feldkirch, Austria Phone: 0043/5522/303-1605 Fax: 0043/5522/303-7520 email: [email protected]
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ACCEPTED MANUSCRIPT Revision of Articular Surface Replacement (ASR™) Total Hip Arthroplasty: Correlation of Perioperative Data and Early Post-Revision Outcome Results
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Abstract
The Articular Surface Replacement (ASR) total hip arthroplasty (THA) showed accelerated failure rates due to adverse-reaction to metal debris (ARMD). Literature correlating
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preoperative data with intraoperative revision findings is rare. No post-revision outcome
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results are published yet. 30 of 99 available ASR THA were revised due to ARMD. Mean post-revision follow-up term was 2.3 ±0.5 years. In part, preoperative data did not correlate
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with intraoperative revision findings. ARMD was even found in asymptomatic patients with non-elevated ion levels. Postoperative pain and metal ion levels decreased significantly
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(p≤0.016). Cobalt decreased faster than Chrome. Patients with intraoperative pseudotumors, osteolysis or bilateral ASR THA did not have higher pre- or postoperative ion values (p≥0.053). Females showed higher postoperative Chrome levels (p=0.031). One major post-
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occurred.
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revision complication (femoral nerve palsy) and one re-revision (late onset infection)
Keywords: Articular Surface Replacement, ASR, Total Hip Arthroplasty, Revision, Outcome
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ACCEPTED MANUSCRIPT Introduction Large diameter metal-on-metal (MOM) bearings for total hip arthroplasty (THA) were
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developed due to proclaimed advantages of decreased wear rates in comparison to polyethylene-on-metal bearings, a lower hip dislocation rate, lower implant fracture risks in comparison to ceramic-on-ceramic bearings, a higher range of motion (ROM) in comparison
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to small headed THA and the opportunity to produce resurfacing hip arthroplasties.[1–7] However, after introducing the Articular Surface Replacement (ASR™) XL THA (DePuy
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Orthopaedics, Inc., Warsaw, IN, USA) accelerated failure rates after short in-situ time were
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found worldwide.[7–14] Langton et al. reported a failure rate of 6% after 41 months and 48.8% after 6 years.[9,10] The National Joint Registry of England and Wales postulated failure rates of 13% after 5 years.[8] Steele at al. published a revision rate of 12% after 1.6
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years.[7] Reito et al. proclaimed a 7 year survivorship of 38% for small headed ASR™ THA.[15] Bernthal et al. reported implant dysfunction in 28.6% with a revision rate of 17.1% after 3 years.[12] This results were comparable to our previously published data verifying a
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revision rate of 24.5% after a mean follow-up term of 3.5 years, mostly due to adverse
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reaction to metal debris (ARMD).[14] ARMD was introduced as umbrella term subsuming metallosis with elevated blood ion levels, soft-tissue lesions and/or pseudotumors, aseptic lymphocytic vasculitis-associated lesions (ALVAL) and implant failure associated with groin pain.[9,11,16,17] However, despite accelerated failure rates of the ASR™ THA were reported several times, to the best of our knowledge, there is a paucity of literature correlating preoperative clinical, radiological and metal ion data with intraoperative revision findings.[9,18,19] Available studies are restricted by a retrospective study design[18] or a limited number of revised ASR™ THA (n ≤ 18)[9,18,19]. Additionally, no fundamental post-revision follow-up data is published yet. Stryker et al.[20] reported a high early complication rate of 20% 14 months after revision of a heterogeneous group of metal-on-metal THA. Matharu et al.[21] had a re3
ACCEPTED MANUSCRIPT revision rate of 12.5% after 4.5 years. Munro et al.[22] reported a higher rate of major complications in at least 38% 25 months after revision of 31 Durom® MOM articulations and
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one ASR™ THA. They reported a decrease of Chrome (Cr) and Cobalt (Co) metal ion levels in 14 of 16 patients after revision surgery.[22] Randelli et al.[19] postulated significant higher ion values for patients with failed ASR™ THA with severe intraoperative acetabular bone
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loss. However, to the best of our knowledge, there is no literature available yet reporting on post-revision follow-up data and blood metal ion levels after explantation of all ASR™ THA
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devices.
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Hence, because we had verified a revision rate of at least 24.5% after 3.5 years [14], preoperative, intraoperative and postoperative data of all patients who underwent revision surgery due to ARMD was analyzed. The main study aims were to find out whether (1)
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preoperative collected data (clinical and radiological results; blood metal ions) do correlate with intraoperative revision findings; (2) blood ion levels significantly decrease after removing of all ASR™ devices, (3) pseudotumors or intraoperativ osteolysis, gender or a
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bilateral implanted ASR™ THA affect pre- and post-revision blood metal ions, (4) and to
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report minimum one year follow-up results after revision surgery.
Materials and Methods At our institution we had implanted 99 ASR™ THA in 88 patients between December 2005 and April 2009. 11 patients received an ASR™ THA on bilateral side. A high early revision rate of this patient cohort was already reported previously.[14] For primary implantation, the ASR™ femoral head was combined with a CoxaFit stem (K-Implant, Hannover, Germany) in 97 of 99 prosthesis, in two cases an ARGE Geradschaft stem (K-Implant, Hannover, Germany) was used. Both stems had a common 12/14 mm taper.[14] 78 implants were performed through a minimal-invasive anterolateral approach.[23] In 21 cases a lateral transgluteal approach was used for primary implantation.[24] 4
ACCEPTED MANUSCRIPT However, by the beginning of January 2014, 31 (31.3%) of 99 ASR™ THA were revised. 30 ASR™ THA (30.3%) were revised due to ARMD. One ASR™ THA was revised due to a late
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onset infection and excluded for this analysis. No other complications with need of revision surgery occurred after primary ASR™ THA. Indication for revision surgery was decided using the guidelines published by the British Hip Society.[25] All revisions were performed
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between 19.07.2010 and 29.11.2013. Mean time to revision surgery after primary implantation was 4.6 ±0.9 (2.7 – 6.7) years. Revision surgery was performed through a
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conventional lateral approach.[24] Müller back plates or Zintra acetabular screw cups
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(Zimmer, Warsaw, Inc., USA) combined with a high molecular weight polyethylene were used for acetabular revision. Loosened femoral stems were replaced with a Zweymueller revision stem. The ASR™ femoral head was removed and a conventional 28 or 32 mm
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femoral head (K-Implant, Hannover, Germany) was implanted. Overall, we were able to revise 28 of 30 ASR™ THA at our institution. Two patients underwent revision surgery in a different hospital. Hence, no intraoperative data was available. All patients gave informed
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consent before they were included in this review board approved study.
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Pre-revision data included baseline characteristics (gender, age, body mass index, ASA Classification[26], side of implantation, surgical approach, size of implanted components) of all patients at time of primary ASR™ THA. (Table 1) Accordingly, clinical and radiological data obtained shortly before revision surgery was analyzed. This data was collected 4.4 ±1.0 [2.5 – 6.6] years after primary ASR™ THA. Clinical parameters included range of motion (ROM), trochanteric pain, push & pull sign and gluteal muscle weakness (Trendelenburg sign). Radiological investigation was performed with conventional hip X-rays taken 3 months after primary ASR™ THA and shortly before revision surgery in anterior-posterior (ap), axial and pelvic view. Acetabular cup inclination angle was measured in frontal plane on pelvic overview by one orthopedic surgeon.[14] A high inter- and intraobserver reliability was already described previously.[27] Osteolytic loosening zones around the acetabular cup and 5
ACCEPTED MANUSCRIPT femoral stem in anterior-posterior and axial view were obtained.[28–31] (Table 2, Figure 1AC) Computer tomography (CT) imaging was performed to detect soft tissue lesions,
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pseudotumors, component loosening and osteolysis. In three cases no CT-scan was available: one patient refused imaging and in two cases no CT was performed due to acetabular cup loosening, which was already diagnosed by conventional X-rays.
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During ASR™ revision surgery we obtained appearance of pseudotumors/soft-tissue lesions, intraarticular effusion, metallosis, osteolysis/cystic bone lesions and loosening of acetabular
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cup or the femoral stem. Intraoperative findings were compared and correlated to preoperative
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clinical, radiological and metal ion data. We were interested whether clinical and radiological data respectively serum ion levels collected before revision surgery do correlate with intraoperative revision findings.
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At least one year after ASR™ revision surgery, patients underwent postoperative clinical and radiological follow-up. Examination included same clinical and radiological parameters as before revision surgery. No computer-tomography imaging was performed. We were able to
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compare pre- with postoperative revision data in 20 of 30 ASR™ THA. 5 patients were lost to
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follow-up: 2 patients had died unrelated to revision surgery; 3 patients were not reached. An additional of 5 patients had been excluded for postoperative clinical data analysis because they were investigated within 12 months after revision surgery. Mean follow-up was 2.3 ±0.5 (1.5 – 3.1) years after ASR™ THA revision surgery. (Figure 2) Chrome and Cobalt levels in serum were collected regularly before and after revision surgery. We were interested whether and how serum ion levels would decrease after explantation of all ASR™ devices. Blood was collected with a 21-gauge venofix butterfly system (B.Braun, Melsungen, Germany) or a 21-gauge multi drawing needle (Greiner Bio-one, Frickenhausen, Germany). Vacuette native tubes or tubes filled with ethylendiamintetraacetate (EDTA) respectively heparine were used to collect blood samples. Accordingly blood samples were diluted with 1:19 diluent (1g/L K-EDTA + 0.25% NH4OH in highly cleaned water) and 6
ACCEPTED MANUSCRIPT analyzed by X-SERIES 2 ICP mass spectrometry (ThermoFisher, Dreieich, Germany). Measuring range was set at 1 to 300 μg/L for Chrome and 1 to 400 μg/L for Cobalt. Serum
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ion levels of more than 7 μg/L were considered as elevated.[25] For statistical analysis we compared highest ion levels measured before revision surgery with the lowest ion levels collected after ASR™ THA revision. To avoid adulteration of ion data, all bilateral ASR™
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THA cases (n = 5) were excluded for statistical analysis. Hence, 20 patients (20 ASR™ THA) were available to compare pre- with postoperative ion levels. (Figure 2) Maximum ion levels
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were measured 48.8 ±11.8 (5.7 – 61.1) months after primary and 5.5 ±6.3 (0 – 28) months
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before ASR™ revision surgery. Minimum ion values were obtained 23.9 ±10.6 (1.6 – 35.2) months after ASR™ revision surgery. However, we did a separate statistical ion analysis comparing pre- and postoperative metal ion levels of unilateral (n = 20) with bilateral (n = 5)
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ASR™ THA. For bilateral cases maximum ion levels were measured 51.8 ±5.6 (45 – 59) months after primary and 11.5 ±8.5 (3 – 24) months before ASR™ revision surgery.
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Minimum ion values were obtained 19.6 ±13.7 (6 – 35) months after ASR™ revision surgery.
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For statistical analysis SPSS Software Version 18 (Chicago, Illinois, USA) was used. For every parameter mean, standard deviation, minimum and maximum values were calculated. For blood ion levels the median value was also analyzed. Significance was set at p < 0.05. Kolmogorov-Smirnov test was used to assume normal distribution. Normal distributed dependent data was compared using paired t-test. Dependent categorical and nominal data was analyzed using Sign and McNemar test, respectively. Independent categorical and nominal data was compared using Fisher`s exact test or Chi-Square test. For independent nonnormal distributed skewed data Mann-Whitney U-Test was used. For comparison of more than two independent groups the Kruskal-Wallis test was performed.
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ACCEPTED MANUSCRIPT Results In part, preoperative collected data did not correlate with intraoperative revision findings. CT
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imaging revealed soft tissue lesions/pseudotumors in 12 (44.4%) of 27 available ASR™ THA. However, in 2 cases no typical pseudotumor was found during revision surgery. Both patients had increased ion levels and showed local metallosis with osteolysis. In 4 cases a
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pseudotumor was found intraoperatively, but not described by CT imaging. 9 ASR™ THA (33.3%) showed acetabular cup and/or femoral stem loosening with CT imaging. However,
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intraoperatively in 3 cases all components were well fixed to the bone without loosening. All
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of these patients suffered from severe pain (VRS = 4), showed highly increased blood ion values and/or intraoperative pseudotumors with metallosis. In 3 cases acetabular loosening was found intraoperatively but not described by preoperative CT.
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X-rays taken shortly before revision surgery revealed acetabular cup loosening in 6 ASR™ THA. Two femoral stems showed accelerated radiological radiolucency in ap and axial view. This was confirmed by CT imaging and even found during revision surgery. Remaining x-
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rays did not show any osteolysis or component loosing. Intraoperative findings showed 5
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cases with solid cystic bone lesions, 6 hips with accelerated osteolysis and 9 loosened acetabular cups. All femoral stems except of two were well fixed to the bone. Intraarticular effusion was revealed in at least 17 cases during surgery. In 19 cases metallosis/black stained soft tissue was found. However, only in 5 cases stained hip aspirate was found preoperatively. Finally, there were 5 patients with non-elevated ion levels < 7 μg/L. Though, pseudotumors were found in 3 cases, metallosis was revealed in 4 patients and two acetabular cups respectively one femoral stem showed aseptic loosening during revision surgery. (Table 3; adapted Table, Cip et al.[14]) Comparison of pre- with postoperative blood ion levels showed a significant decrease for both Chrome and Cobalt (p < 0.001) in all patients. (Figure 3) Every patient showed lower ion values after ASR™ THA revision surgery than before. Delta ion parameters (highest 8
ACCEPTED MANUSCRIPT preoperative minus lowest postoperative ion value) revealed a faster decrease for Cobalt than for Chrome in all evaluations. (Table 4; Figure 4)
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There were no statistical significant differences within preoperative or postoperative Chrome or Cobalt values or delta ion values when comparing groups of intraoperative pseudotumor (yes vs. no), intraoperative osteolysis (yes vs. no), intraoperative component loosening (yes
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vs. no), gender (female vs. male) or unilateral versus bilateral ASR™ THA (p ≥ 0.053). Only females showed significant higher postoperative Chrome levels than male patients did (p =
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0.031) based no a higher mean preoperative Chrome level, which was not statistically
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significant (p = 0.181).
Overall, one major post-revision complication occurred by the end of this trial: One patient showed immediate postoperative femoral nerve palsy due to a nerve traction injury. In
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addition one re-revision was performed due to a late onset infection 8 months after initial revision surgery, which included a polyethylene-inlay and femoral head change. Remaining revision procedures showed no major complications (e.g. infection, aseptic loosening,
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periprosthetic fracture, nerve injuries) or need of a re-revision surgery at a mean follow-up
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term of 2.3 ±0.5 (1.5 – 3.1) years after initial revision procedure. By the end of this trial there was even no hip dislocation in the whole study cohort. Compared to pre-revision data we found a significant decreased postoperative pain intensity level (p = 0.016). However, 2 patients suffered still from severe pain (VRS = 4) and five patients claimed about moderate pain (VRS = 3). The postoperative HSS was not significant different (p = 0.650). No significant differences were revealed when comparing pre- with postoperative ROM (p ≥ 0.101). However, a higher mean abduction was revealed at least one year postoperatively (p = 0.045). (Table 5) Additionally, also those five patients, who were investigated within one year after revision surgery and excluded for clinical statistical analysis, improved with a postoperative VRS of 1.8 ±0.8 (1 – 3) and HHS of 90.4 ±10.4 (72 – 97).
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ACCEPTED MANUSCRIPT Discussion After introducing ASR™ THA accelerated failure rates after short term were reported
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worldwide.[7–14] Soft-tissue lesions, pseudotumors, component loosening, metallosis, elevated blood ion levels, ALVAL and accelerated groin pain were found and described as ARMD.[9,11,16,17] ARMD was reported as main reason for early ASR™ THA
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failure.[14,15]
However, so far there are only few articles reporting on metal-on-metal intraoperative
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revision findings.[9,18,19] Available studies are restricted by a retrospective study design or a
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limited number of ASR™ THA revised due to ARMD (n ≤18).[9,18,19] Additionally, to the best of our knowledge, there is no post-revision data published yet, dealing with patients who underwent ASR™ THA revision surgery. Several authors are reporting on a high early post-
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revision complication rate of 20% or more after revision of several different metal-on-metal THA. [20,22] Munro et al.[22] published a decrease of Chrome and Cobalt levels in 14 of 16 patients after revision surgery. However, nothing is known whether and how fast elevated
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blood ion levels decrease after explantation of ASR™ THA. No recent post-revision follow-
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up data is published yet. Because we had revised 30 ASR™ THA devices due to ARMD, we are reporting on pre-, intra- and post-revision clinical, radiological and metal ion data. The study was restricted by several limitations. First, baseline characteristics and pre-revision data was collected retrospectively. Nevertheless, we had a complete follow-up rate for all parameters. Only in two cases we were not able to obtain the preoperative HHS. Intraoperative and postoperative data was collected prospectively. Second, 5 patients were lost to postoperative follow-up. An additional of 5 patients were excluded due to a minimum one year follow-up after revision surgery. We think that a minimum post-revision follow-up term of at least one year was necessary to avoid adulteration of postoperative clinical data. A short follow-up term may had influenced ROM, HHS and VRS results. However, all of those
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ACCEPTED MANUSCRIPT patients improved clinically already after short follow-up term and were also included for metal ion analysis.
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There were discrepancies between preoperative CT imaging and intraoperative revision findings. Metal artifacts led to a reduced imaging quality and affected interpretations of CT scans. In 4 patients an intraoperative pseudotumor/soft tissue lesion was not found by
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preoperative imaging. Kwon et al.[32] already described metal artifact reduction sequence (MARS) magnet resonance imaging (MRI) as an important cross-sectional imaging to detect
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ARMD around metal-on-metal implants. In a previous analysis, we already reported lower
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rates of soft tissue lesions when using CT imaging in comparison to literature using MARSMRI.[14] A lower sensitivity for CT scan may explain these discrepancies.[14] Additionally, we had three patients where osteolysis was found intraoperatively but not seen with
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preoperative CT-scan. Randelli et al.[19] also described unexpected intraoperative osteolysis when using MRI and plain radiographs for preoperative imaging. The authors described in detail a reduced ability to detect osteolysis around metal-on-metal bearings, especially in
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presence of local metallosis.[19] CT imaging may be superior to detect osteolysis and
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component loosening around metal-on-metal bearings in comparison to MARS MRI. In addition CT is less time consuming, mostly easy available and cheaper than MARS MRI. However, based on our discrepancies between preoperative imaging results and intraoperative revision findings, MARS MRI and even ultrasound imaging should be used as golden standard to detect even smaller soft tissue lesions and/or intraarticular effusion around MOM bearings. Nawabi et al.[33] reported MRI as a sensitive and specific tool in detecting soft tissue damage in patients with an implanted metal-on-metal hip. Intraarticular effusion was found in most of our revision procedures. However, only five cases revealed a stained preoperative hip aspiration. Small amount of intraarticular effusion may be difficult to aspirate. Ultrasound imaging is time consuming and investigator depended, but cheap and an established tool without radiation exposure. Hence, this technique could be used to detect 11
ACCEPTED MANUSCRIPT even small amounts of intraarticular effusion around MOM bearings, which may be an important initial sign of ARMD. Elevated ion levels were considered to be predictive for
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ARMD and local metallosis.[14,34] However, five patients had ion levels within a threshold that was considered as “low risk” in recently published guidelines.[32] We found pseudotumors, metallosis and aseptic component loosening when serum ion levels were less
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than 7 μg/L respectively 2 μg/L. Consequently, low ion values do not exclude ARMD. Similar findings were reported previously.[35] In addition, also a pain free and asymptomatic
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hip may have ARMD. We had asymptomatic patients where elevated ion levels,
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intraoperative pseudotumors and metallosis was found. A close clinical and radiological follow-up is recommended even in asymptomatic patients with low ion levels. Unspecific or mild symptoms of groin pain could be a first sign of ARMD.
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Corrosion along the surface of the femoral stem or at MOM modular junctions was described as one leading cause of elevated metal ions.[11,36] For ASR™ THA increased wear was not only described on the articulation surface but also at the trunnion-taper interface, the
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connection between the femoral stem and head.[10] However, because we did not find any
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severe trunnion damage, we left the well fixed femoral stem in at least all patients except in 2 cases, where the femoral stem was loosened. Nevertheless, after explantation of all ASR™ devices, serum ion levels decreased significantly in all patients, even after a short follow-up term. This results confirm that the ASR™ THA devices were the main source of blood metal ions. Hence, we recommend not to revise a well fixed femoral stem unnecessarily if there is no severe macroscopic trunnion damage. Matthies et al.[37] already reported a negligible volume of material loss at the male taper of the femoral stem in comparison to the female taper of the femoral head or the articular bearing surface. Cobalt and Chrome are excreted by the kidney.[38,39] However, our results verified that Cobalt values decreased faster than those for Chrome. This may be related to a different excretion pathway. Keegan et al.[39] described that Cobalt is rapidly excreted by the kidney 12
ACCEPTED MANUSCRIPT whereas Chrome is concentrated in the epithelial cells of the proximal renal tubules. This may explain a slower excretion and serum level decrease of Chrome. Hence, if patients show
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highly elevated ion values, especially Chrome levels may be elevated for years after revision surgery. There is still no consensus whether and at which threshold blood metal ions are toxic for patients with metal-on-metal arthroplasties. Not only local tissue reactions but also
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systemic side effects with cardio toxicity, neurotoxicity, terratogenic or cancerogenic effects were described previously.[39] Hence, we recommend a close clinical follow-up, measuring
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metal ions regularly, even when all ASR™ THA devices are removed.
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Randelli et al.[19] reported that patients with severe intraoperative acetabular bone loss were associated with significant higher serum ion levels. We could not confirm significant differences within patients with or without intraoperative osteolysis, pseudotumors or
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component loosening regarding pre- or postoperative ion values. There was also no difference within unilateral versus bilateral ASR™ THA. The relatively small number of bilateral cases may account for this findings. However, this results were in accordance to data published by
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De Smet et al.[40]. Females had significant higher postoperative Chrome values compared to
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the male cohort (p = 0.031). Even preoperatively Chrome was nearly twice as much for female patients in comparison to male patients. Higher metal ion values with a higher risk for ARMD for female patients due to differences in acetabular cup version angles or femoral head diameter was reported in literature several times.[15,16,41] All evaluations revealed a significant decrease of metal ions after revision surgery. This is comparable to the results published by Munro et al.[22]. Stryker et al.[20] reported a high early complication rate of 20% after revision of a heterogeneous group of metal-on-metal THA. Munro et al.[22] published major complications in at least 38% after revision of 31 Durom® MOM articulations and one ASR™ THA. In our study cohort we had one immediate major post-revision complication including a femoral nerve palsy. No re-revision procedure was necessary in this case. However, one re-revision 13
ACCEPTED MANUSCRIPT surgery was performed due to a late onset infection 8 months later, which can not be related to the initial revision procedure. The discrepancies within our satisfying post-revision results and
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the high complication rate reported previously[20,22] may be related to their extremely high early hip dislocation [22] or aseptic loosening rate [20,22]. A posterior approach used by Munro et al.[22] combined with different implants compared to the current study may had
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resulted in a higher rate of instability and consequently in a higher hip dislocation rate.[42] Additionally, a direct comparison to previous study results [20,22] is difficult due to a
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heterogeneous patient cohort including several different MOM implants, patients with
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variable degrees of osteolysis or soft-tissue lesions and different post-revision follow-up terms.
To summarize, patients even with an already revised ASR™ THA must undergo close clinical
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follow-up including regular metal ion measurement. A pain free hip or normal ion levels do not exclude ARMD. CT is a useful and fast screening tool to detect component loosening, osteolysis or soft tissue lesions. Inconspicuous imaging does not exclude ARMD. MARS
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MRI may be superior to detect soft tissue lesions. We recommend establishing ultrasound
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imaging in screening patients with metal-on-metal hip implants. An intraarticular effusion may be an initial sign for ARMD. Revision of ASR™ THA reduces blood ion levels significantly. We think that revision of a well-fixed femoral stem without any severe macroscopic trunnion damage is not necessary. In our study cohort acceptable early postrevision results were obtained. Surgeons should follow previous published guidelines to indicate revision surgery sufficiently early to end up in satisfying short-term post-revision results.
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ACCEPTED MANUSCRIPT Literature Amstutz HC, Le Duff MJ, Beaulé PE. Prevention and treatment of dislocation after total hip replacement using large diameter balls. Clin Orthop Relat Res 2004:108–16.
[2]
Anissian HL, Stark A, Gustafson A, Good V, Clarke IC. Metal-on-metal bearing in hip prosthesis generates 100-fold less wear debris than metal-on-polyethylene. Acta Orthop Scand 1999;70:578–82.
[3]
Cohen D. Out of joint: the story of the ASR. BMJ 2011;342:d2905.
[4]
Cuckler JM, Moore KD, Lombardi A V, McPherson E, Emerson R. Large versus small femoral heads in metal-on-metal total hip arthroplasty. J Arthroplasty 2004;19:41–4.
[5]
Lombardi A V, Skeels MD, Berend KR, Adams JB, Franchi OJ. Do large heads enhance stability and restore native anatomy in primary total hip arthroplasty? Clin Orthop Relat Res 2011;469:1547–53.
[6]
Sikes C Van, Lai LP, Schreiber M, Mont MA, Jinnah RH, Seyler TM. Instability after total hip arthroplasty: treatment with large femoral heads vs constrained liners. J Arthroplasty 2008;23:59–63.
[7]
Steele GD, Fehring TK, Odum SM, Dennos AC, Nadaud MC. Early failure of articular surface replacement XL total hip arthroplasty. J Arthroplasty 2011;26:14–8.
[8]
De Steiger RN, Hang JR, Miller LN, Graves SE, Davidson DC. Five-year results of the ASR XL Acetabular System and the ASR Hip Resurfacing System: an analysis from the Australian Orthopaedic Association National Joint Replacement Registry. J Bone Joint Surg Am 2011;93:2287–93.
[9]
Langton DJ, Jameson SS, Joyce TJ, Hallab NJ, Natu S, Nargol AVF. Early failure of metal-on-metal bearings in hip resurfacing and large-diameter total hip replacement: A consequence of excess wear. J Bone Joint Surg Br 2010;92:38–46.
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[1]
[10] Langton DJ, Jameson SS, Joyce TJ, Gandhi JN, Sidaginamale R, Mereddy P, et al. Accelerating failure rate of the ASR total hip replacement. J Bone Joint Surg Br 2011;93:1011–6. [11] Bolland BJRF, Culliford DJ, Langton DJ, Millington JPS, Arden NK, Latham JM. High failure rates with a large-diameter hybrid metal-on-metal total hip replacement: clinical, radiological and retrieval analysis. J Bone Joint Surg Br 2011;93:608–15. [12] Bernthal NM, Celestre PC, Stavrakis AI, Ludington JC, Oakes DA. Disappointing short-term results with the DePuy ASR XL metal-on-metal total hip arthroplasty. J Arthroplasty 2012;27:539–44. [13] Smith AJ, Dieppe P, Vernon K, Porter M, Blom AW. Failure rates of stemmed metalon-metal hip replacements: analysis of data from the National Joint Registry of England and Wales. Lancet 2012;379:1199–204.
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ACCEPTED MANUSCRIPT [14] Cip J, von Strempel A, Bach C, Luegmair M, Benesch T, Martin A. Implication of Femoral Stem on Performance of Articular Surface Replacement (ASR) XL Total Hip Arthroplasty. J Arthroplasty 2014.
RI PT
[15] Reito A, Puolakka T, Elo P, Pajamäki J, Eskelinen A. High prevalence of adverse reactions to metal debris in small-headed ASR™ hips. Clin Orthop Relat Res 2013;471:2954–61. [16] Haddad FS, Thakrar RR, Hart AJ, Skinner JA, Nargol AVF, Nolan JF, et al. Metal-onmetal bearings: the evidence so far. J Bone Joint Surg Br 2011;93:572–9.
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[17] Willert H-G, Buchhorn GH, Fayyazi A, Flury R, Windler M, Köster G, et al. Metal-onmetal bearings and hypersensitivity in patients with artificial hip joints. A clinical and histomorphological study. J Bone Joint Surg Am 2005;87:28–36.
MA
[18] Hug KT, Watters TS, Vail TP, Bolognesi MP. The withdrawn ASR™ THA and hip resurfacing systems: how have our patients fared over 1 to 6 years? Clin Orthop Relat Res 2013;471:430–8.
PT ED
[19] Randelli F, Banci L, Favilla S, Maglione D, Aliprandi A. Radiographically undetectable periprosthetic osteolysis with ASR implants: the implication of blood metal ions. J Arthroplasty 2013;28:1259–64. [20] Stryker LS, Odum SM, Fehring TK, Springer BD. Revisions of Monoblock Metal-onmetal THAs Have High Early Complication Rates. Clin Orthop Relat Res 2014.
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[21] Matharu GS, Pynsent PB, Sumathi VP, Mittal S, Buckley CD, Dunlop DJ, et al. Predictors of time to revision and clinical outcomes following revision of metal-onmetal hip replacements for adverse reaction to metal debris. Bone Joint J 2014;96B:1600–9.
AC
[22] Munro JT, Masri BA, Duncan CP, Garbuz DS. High complication rate after revision of large-head metal-on-metal total hip arthroplasty. Clin Orthop Relat Res 2014;472:523– 8. [23] Bertin KC, Röttinger H. Anterolateral mini-incision hip replacement surgery: a modified Watson-Jones approach. Clin Orthop Relat Res 2004:248–55. [24] Bauer R, Kerschbaumer F, Poisel S, Oberthaler W. The transgluteal approach to the hip joint. Arch Orthop Trauma Surg 1979;95:47–9. [25] Association BO. Withdrawal of DePuy ASR Resurfacing and XL Metal on Metal Bearings - Information for and Advice to Surgeons from the British Hip Society and the British Orthopaedic Association. Online 2010. [26] Little JP. Consistency of ASA grading. Anaesthesia 1995;50:658–9. [27] Patel SR, Toms AP, Rehman JM, Wimhurst J. A reliability study of measurement tools available on standard picture archiving and communication system workstations for the evaluation of hip radiographs following arthroplasty. J Bone Joint Surg Am 2011;93:1712–9. 16
ACCEPTED MANUSCRIPT [28] Gruen TA, McNeice GM, Amstutz HC. “Modes of failure” of cemented stem-type femoral components: a radiographic analysis of loosening. Clin Orthop Relat Res 1979:17–27.
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[29] DeLee JG, Charnley J. Radiological demarcation of cemented sockets in total hip replacement. Clin Orthop Relat Res:20–32. [30] Charnley J. Total prosthetic replacement of the hip. Reconstr Surg Traumatol 1969;11:9–19.
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[31] Johnston RC, Fitzgerald RH, Harris WH, Poss R, Müller ME, Sledge CB. Clinical and radiographic evaluation of total hip replacement. A standard system of terminology for reporting results. J Bone Joint Surg Am 1990;72:161–8.
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[32] Kwon Y-M, Lombardi A V, Jacobs JJ, Fehring TK, Lewis CG, Cabanela ME. Risk stratification algorithm for management of patients with metal-on-metal hip arthroplasty: consensus statement of the American Association of Hip and Knee Surgeons, the American Academy of Orthopaedic Surgeons, and the Hip Society. J Bone Joint Surg Am 2014;96:e4.
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[33] Nawabi DH, Gold S, Lyman S, Fields K, Padgett DE, Potter HG. MRI predicts ALVAL and tissue damage in metal-on-metal hip arthroplasty. Clin Orthop Relat Res 2014;472:471–81.
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[34] Chang EY, McAnally JL, Van Horne JR, Van Horne JG, Wolfson T, Gamst A, et al. Relationship of plasma metal ions and clinical and imaging findings in patients with ASR XL metal-on-metal total hip replacements. J Bone Joint Surg Am 2013;95:2015– 20.
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[35] Macnair RD, Wynn-Jones H, Wimhurst JA, Toms A, Cahir J. Metal ion levels not sufficient as a screening measure for adverse reactions in metal-on-metal hip arthroplasties. J Arthroplasty 2013;28:78–83. [36] Jacobs JJ, Cooper HJ, Urban RM, Wixson RL, Della Valle CJ. What do we know about taper corrosion in total hip arthroplasty? J Arthroplasty 2014;29:668–9. [37] Matthies AK, Racasan R, Bills P, Blunt L, Cro S, Panagiotidou A, et al. Material loss at the taper junction of retrieved large head metal-on-metal total hip replacements. J Orthop Res 2013;31:1677–85. [38] Corradi M, Daniel J, Ziaee H, Alinovi R, Mutti A, McMinn DJW. Early markers of nephrotoxicity in patients with metal-on-metal hip arthroplasty. Clin Orthop Relat Res 2011;469:1651–9. [39] Keegan GM, Learmonth ID, Case CP. Orthopaedic metals and their potential toxicity in the arthroplasty patient: A review of current knowledge and future strategies. J Bone Joint Surg Br 2007;89:567–73. [40] De Smet K, De Haan R, Calistri A, Campbell PA, Ebramzadeh E, Pattyn C, et al. Metal ion measurement as a diagnostic tool to identify problems with metal-on-metal hip resurfacing. J Bone Joint Surg Am 2008;90 Suppl 4:202–8. 17
ACCEPTED MANUSCRIPT [41] De Haan R, Pattyn C, Gill HS, Murray DW, Campbell PA, De Smet K. Correlation between inclination of the acetabular component and metal ion levels in metal-onmetal hip resurfacing replacement. J Bone Joint Surg Br 2008;90:1291–7.
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[42] Kwon MS, Kuskowski M, Mulhall KJ, Macaulay W, Brown TE, Saleh KJ. Does surgical approach affect total hip arthroplasty dislocation rates? Clin Orthop Relat Res 2006;447:34–8.
18
ACCEPTED MANUSCRIPT Table 1: Demographic data of all 30 ASR™ THA (at primary implantation) Parameter Gender (n) 14
Men
16
Patient age (years)
49.6 ± 8.5 (21-61)
Body mass index (kg/cm²)
27.7 ± 3.7 (19-47)
SC
RI PT
Women
I
18
II
NU
ASA Classification (n)
12
III - V
0
MA
Side of implantation (n) Left
Surgical approach (n)
PT ED
Right
21 9
26
Conventional lateral approach
4
Size of acetabular component (mm)
53.6 ± 5.6 (44-64)
Size of femoral head (mm)
47.5 ± 4.7 (39-57)
Size of implanted conus (mm)
3.7 ± 2.2 (2 - 8)
Size of implanted stem (mm) ASA = American Society of Anesthesiologists
12.6 ± 2.3 (10-18)
AC
CE
Minimal invasive anterolateral approach
19
ACCEPTED MANUSCRIPT
Table 2: Clinical and Radiological data shortly before ASR™ revision surgery (n = 30 ASR™ THA) Radiological Parameter
Range of motion (ROM)
Acetabular loosening zones in anterior-posterior view (n)
PT
Clinical Parameter
101.3 ± 14.6 (70 - 130)
Zone I
Abduction
31.9 ± 11.7 (10 - 60)
Zone II
Adduction
27.4 ± 8.7 (10 - 45)
Zone III
Internal rotation
21.3 ± 8.7 (5 - 40)
Femoral loosening zones in anterior-posterior view (n)
External rotation
23.5 ± 11.4 (5 - 50)
Zone I
2 x 2 mm
MA NU SC
RI
Flexion
1 x 1 mm 1 x 1 mm 1 x 1 mm
Zone II
1 x 1 mm; 2 x 2 mm
Positive
3
Zone VI
2 x 1 mm
Negative
21
Zone VII
1 x 2 mm
push & pull sign (n)
Trochanteric pain (n)
Femoral loosening zones in lateral view (n) 7
Zone VIII
1 x 8 mm
Negative
14
Zone IX
1 x 5 mm
Zone XIII
2 x 1 mm
Zone XIV
1 x 1 mm
ED
Positive
Positive
1
Negative
17
PT
Trendelenburg sign (n)
CE
Verbal Rating Scale (n)
Acetabular inclination angle shortly after primary ASR™ implantation [1] (°)
45.5 ± 8.3 (34 - 77)
Inclination angle more than 50° (n)
7
Inclination angle 50° or less (n)
23
Inclination angle more than 45° (n)
11
3
Mild pain (2)
5
Moderate pain (3)
12
Severe pain (4)
8
Very severe pain (5)
2
Worst possible pain (6)
0
Inclination angle within 40 - 45° (n)
13
VRS overall
3.0 ± 1.1 (1 - 5)
Inclination angle below 40° (n)
6
Harris Hip Score (before primary implantation)
55.7 ± 16.0 (24 - 87)
Shortly before ASR™ revision surgery [2] (°)
47.3 ± 10.8 (34 - 76)
Harris Hip Score (6 weeks after implantation)
90.8 ± 8.7 (62 - 100)
Relative difference within inclination angle [1] and [2] (°)
1.8 ± 5.6 (-5 - 16)
Absolute difference within inclination angle [1] and [2] (°)
3.6 ± 4.6 (0 - 16)
AC
No pain (1)
81.9 ± 14.9 (52 - 100) Harris Hip Score (shortly before revision surgery) Values are presented as mean ± standard deviation (minimum - maximum)
20
ACCEPTED MANUSCRIPT
Scores (prerevision )
Blood Ion Level
Intraoperati ve Findings
Acetabula r inclinatio n angle (prerevision)
Radiology
No .
Reason for revision
Revision (years)
Gender
Acetabula r cup size
HH S
VR S
Acetabular inclination angle (shortly after implantatio n)
Differenc e
CT: Component loosening
1
ARMD: Ion elevation
6,6
female
50
45
98
1
42
40
2
-
-
2
ARMD: Ion elevation, metallosis
5,0
female
50
45
96
2
77
76
1
#
#
3
ARMD: Ion elevation, pseudotumor
5,0
male
56
49
65
3
44
45
1
4
ARMD: Component loosening, metallosis
4,0
female
52
46
93
3
43
59
16
5
ARMD: Increased pain levels, metallosis
4,8
male
58
51
96
3
34
35
1
6
ARMD: Ion elevation, pseudotumor
4,9
female
50
45
96
2
35
34
1
7
ARMD: Component loosening, pseudotumor, ion elevation
4,6
male
64
57
95
3
37
37
0
8
ARMD: High pain intensity, ion elevation, metallosis
5,0
female
46
41
71
4
39
42
3
9
ARMD: Component loosening, pseudotumor, pain, ion elevation
4,2
male
60
53
n.a.
4
51
53
2
10
ARMD: Ion elevation, metallosis
4,3
female
50
45
100
1
42
41
1
11
ARMD: Component loosening, ion elevation
2,7
male
54
47
55
3
40
40
0
12
ARMD: Component loosening, ion elevation, metallosis
4,6
male
54
47
96
2
50
49
13
ARMD: Ion elevation, highly increased acetabular inclination
4,6
female
50
45
89
2
49
64
14
ARMD: Component loosening, pseudotumor, pain
4,1
male
52
46
80
4
38
37
15
ARMD: Pseudotumor, ion elevation, metallosis
4,6
female
48
43
99
1
41
16
ARMD: Pseudotumor, ion elevation, metallosis
6,1
male
54
47
76
3
42
17
ARMD: Component loosening, ion elevation, pain
3,4
male
58
51
75
4
38
18
ARMD: Pseudotumor, ion elevation, metallosis
5,2
male
62
55
81
2
19
ARMD: High pain intensity, highly increased acetabular inclinaton
2,7
female
50
45
61
20
ARMD: Ion elevation, rising pain intensity
4,5
female
44
39
78
21
ARMD: Accelerated pain intensity level, elevated ions
5,6
female
46
41
86
22
ARMD: Steeply increased acetabular inclination, ion elevation, pain
4,4
female
48
43
n.a.
23
ARMD: Pseudotumor, ion elevation, metallosis
6,3
male
60
53
24
ARMD: Ion elevation, pseudotumor, metallosis
4,9
male
60
53
25
ARMD: Component loosening, pseudotumor, ion elevation
4,8
male
60
26
ARMD: Pain, ion elevation, pseudotumor
4,5
female
27
ARMD: component loosening, accelerated pain
4,0
28
ARMD: Accelerated pain, ion elevation
29
ARMD: Increased inclination angle, ion elevation, pain
CT: Pseudotum or
Preoperati ve Hip Aspirate with metallosis
Chrom e (µg/L)
Cobal t (µg/L )
Intraarticul ar effusion
Metallosi s
-
27,0
36,0
-
yes
yes
125,0
165,0
yes
MA NU SC
Femoral stem loosenin g
Pseudotum or
Cysti c lesion s
Osteolysi s
Acetabular component loosening
-
yes
-
-
-
yes
yes
yes
-
-
-
-
yes
-
6,9
11,0
yes
yes
yes
-
-
-
-
yes
-
-
2,0
2,0
yes
yes
yes
-
-
yes
yes
-
-
-
4,4
1,5
yes
yes
-
-
-
-
-
-
yes
-
12,0
15,0
-
-
-
-
yes
-
-
yes
yes
-
3,2
13,0
-
yes
yes
-
yes
yes
-
-
-
yes
12,0
5,2
yes
yes
-
-
-
yes
-
yes
yes
-
13,0
24,0
*** ***
-
-
9,5
14,0
-
-
1
8,5
-
-
-
-
-
yes
-
1
yes
-
-
9,8
14
yes
yes
yes
-
-
yes
-
15
-
-
-
12
18
yes
yes
-
-
-
-
-
1
yes
yes
-
1,6
1
-
yes
yes
-
-
-
yes
37
4
-
yes
yes
14
12
yes
yes
yes
-
-
-
-
42
0
-
yes
-
16
19
-
-
yes
-
yes
-
-
40
2
yes
-
-
5,1
11
yes
-
-
-
-
-
-
43
40
3
-
yes
-
4,3
12
-
yes
-
-
-
-
-
5
53
68
15
-
-
-
1,5
1,3
-
-
yes
-
-
yes
-
3
53
57
4
-
-
-
64
72
-
yes
-
-
-
-
-
3
44
44
0
-
-
-
13
6
-
-
-
-
-
-
-
5
42
~
~
~
~
-
6,6
15
yes
-
-
-
yes
yes
-
86
3
45
40
5
-
yes
-
3,6
11
-
yes
yes
yes
-
-
-
96
3
54
50
4
-
yes
yes
95
217
yes
yes
yes
yes
-
-
-
53
96
3
55
53
2
yes
yes
yes
53
50
yes
yes
yes
-
yes
-
-
46
41
52
4
49
53
4
-
yes
-
77
132
yes
-
yes
yes
-
-
-
male
62
55
62
4
42
44
2
yes
-
-
2,9
3,7
yes
yes
-
-
-
-
-
3,2
female
50
45
70
4
43
42
1
-
-
-
11
17
yes
-
-
-
-
-
-
5,4
male
56
49
61
4
51
61
10
-
-
-
7,1
4,1
yes
yes
yes
-
-
yes
-
~
~
~
~
-
62
70
yes
yes
yes
-
yes
yes
-
AC
CE
PT
-
yes
ED
30
Femor al head size
RI
Baselinecharacterisit cs
PT
Table 3: Comparison Pre-revision and Intraoperative Data
ARMD: Steeply increased acetabular inclination, ion 4,2 male 58 51 84 3 49 elevation, pain - = not found; # = CT refused; ~ = steeply increased inclination angle; n.a. = not evaluated/missing value; *** = revision performed in a different hospital, no intraoperative data available ARMD = adverse reaction to metal debris; HHS = Harris Hip Score; VRS = Verbal Rating Scale; CT = Computer tomography
21
ACCEPTED MANUSCRIPT
Table 4: Blood Ion Statistics: Comparison of pre and postoperative serum ion data (unilateral ASR ™ THA) Chrome (µg/L) (postoperative)
delta Chrome (µg/L)
p-value
Cobalt (µg/L) (preoperative)
PT
Chrome (µg/L) (preoeprative)
Parameter
Cobalt (µg/L) (postoperative)
delta Cobalt (µg/L)
p-value
36.9 ± 60.3 (0 - 216) / 13.0
< 0.001*
overall (n = 20)
23.8 ± 35.3 (1.6 – 125) / 8.3 5.1 ± 8.9 (1 - 36) / 1.5
18.7 ± 27.5 (0 - 88.9) / 6.5 < 0.001* 37.9 ± 60.3 (1 - 217) / 14.0 1.1 ± 0.2 (1 - 2) / 1.0
Gender
female (n = 8)
33.9 ± 44.0 (2 - 125) / 12.0
7.9 ± 11.8 (1 - 36) / 2.8
26.0 ± 33.3 (1 - 89) / 9.9
male (n = 12)
17.1 ± 28.2 ( 2 - 95) / 6.0
3.2 ± 6.3 (1.0 - 23) / 1.0 13.9 ± 23.1 (0 - 72) / 4.4
p-value
0.181
0.031*
0.157
yes (n = 11)
34.9 ± 44.9 (2 - 125) / 7.1
7.3 ± 11.6 (1 - 36) / 1.0
27.7 ± 34.9 (0 - 88.9) / 6.1 0.012*
56.4 ± 77.4 (1 - 217) / 13.0 1.0 ± 0.0 (1) /1.0
55.4 ± 77.4 (0 - 216) / 4.2
0.002*
no (n = 7)
10.0 ± 8.3 (3 - 27) / 6.6
2.5 ± 2.6 (1 - 8) / 1.3
7.5 ± 6.0 (2 - 19) / 4.2
14.3 ± 11.3 (2 - 36) / 15.0
1.1 ± 0.2 (1 - 2) / 1.0
13.2 ± 11.2 (1 - 34) / 14.0
0.016*
p-value
0.791
0.930
0.860
0.791
0.659
0.791
yes (n = 4)
18.7 ± 23.2 (3 - 53) / 9.0
1.8 ± 1.0 (1 - 3) / 2.0
22.3 ± 17.9 (12 - 49) / 14.0
no (n = 14)
27.1 ± 40.6 (2 - 125) / 7.0
p-value
0.878 5.1 ± 3.3 (2 - 10) / 4.9
1.2 ± 0.6 (1 - 2) / 1.0
3.8 ± 3.2 (1 - 9) / 3.2
no (n = 12)
35.3 ± 42.2 (3 - 125) / 12.0
7.5 ± 11.0 (1 - 36) / 2.6
27.8 ± 32.7 (0 - 89) / 9.9
p-value
0.053
0.067
Component looseninga yes (n = 6)
Unilateral versus Bilateral ASR™ THA
49.6 ± 62.4 (2 - 165) / 16.5 1.1 ± 0.2 (1 - 2) / 1.0
48.6 ± 62.4 (1 - 164) / 15.5
0.008*
0.006*
30.1 ± 60.3 (1 - 217) / 11.0 1.0 ± 0.1 (1 - 2) / 1.0
29.1 ± 60.3 (0 - 216) / 10.0
0.001*
0.098
0.098
ED
MA NU SC
0.008*
0.016*
0.851
0.125
23.3 ± 17.9 (13 - 50) / 15
1.0 ± 0.0 (1) / 1.0
6.5 ± 10.4 (1 - 36) / 1.2
20.7 ± 30.9 (0 - 89) / 5.4
0.002*
44.8 ± 71.2 (1 - 217) / 11
1.0 ± 0.2 (1.0 - 1.6) / 1.0 43.8 ± 71.2 (0 - 216) / 10.0
0.789
0.878
0.382
0.878
0.382
0.031*
8.2 ± 6.5 (1 - 15) / 8.6
1.0 ± 0.0 (1) / 1.0
7.2 ± 6.5 (0 - 14) / 7.6
0.063
0.006*
55.9 ± 73.2 (2 - 217) / 16.5 1.1 ± 0.2 (1 - 2) /1.0
54.9 ± 73.2 (1 - 216) / 15.5
< 0.001*
0.102
0.102
PT
16.9 ± 23.6 (2 - 52) / 6.7
CE
Osteolysisa
AC
Pseudotumora
RI
Overall
0.102
0.820
0.125 < 0.001*
unilateral (n = 20) 23.8 ± 35.3 (1.6 – 125) / 8.3 5.1 ± 8.9 (1 - 36) / 1.5
18.7 ± 27.5 (0 - 88.9) / 6.5 < 0.001* 37.9 ± 60.3 (1 - 217) / 14.0 1.1 ± 0.2 (1 - 2) / 1.0
36.9 ± 60.3 (0 - 216) / 13.0
< 0.001*
bilateral (n = 5)
19.5 ± 24.6 (3 - 63) / 10.2
0.063
22.3 ± 23.8 (4 - 64) / 14.0
2.8 ± 2.3 (1 - 6) / 1.3
0.063
p-value 0.272 0.974 0.408 * = Significant different; values are represented as mean ± standard deviation (minimum - maximum) / median value; delta = preoperative value - postoperative value; a = two patients were revised at a different hospital, no intraoperative data available
24.2 ± 27.1 (6 - 72) / 12.0
2.7 ± 2.9 (1 - 8) / 1.0
21.5 ± 27.8 (5 - 71) / 11.0
0.921
0.272
0.668
22
ACCEPTED MANUSCRIPT Table 5: Comparison of preoperative with postoperative clinical results (n = 20 ASR ™ THA) before revision
Flexion
100.5 ± 14.7 (70 - 130) 100.5 ± 12.9 (80 - 125)
0.999
Abduction
32.2 ± 12.1 (20 - 60)
40.0 ± 8.3 (25 - 50)
0.045*
Adduction
27.0 ± 9.6 (10 - 45)
27.9 ± 5.8 (15 - 40)
0.949
Internal Rotation
21.5 ± 9.6 (5 - 40)
20.3 ±10.6 (0 - 45)
0.789
External Rotation
24.1 ± 11.9 (5 - 50)
30.3 ± 8.3 (15 - 40)
0.101
Positive
3
0
0.250
Negative
11
SC
NU
Push & pull sign (n)
MA
Trochanteric pain (n) Positive
after revision
RI PT
Parameter
20
4
7
10
13
0
5
10
15
2
7
4
5
Moderate pain (3)
7
5
Severe pain (4)
6
2
Very severe pain (5)
1
0
Worst possible pain (6)
0
0
VRS overall
3.0 ± 1.1 (1 - 5)
2.1 ± 1.0 (1 - 4)
Trendelenburg sign (n) Positive Negative
CE
Verbal Rating Scale (n)
AC
No pain (1) Mild pain (2)
PT ED
Negative
p-values
85.9 ± 14.7 (52 - 100) 85.1 ± 14.7 (45 - 100) Harris Hip Score *=Significant different; values are presented as mean ± standard deviation (minimum - maximum)
0.688
0.250
0.016* 0.650
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ACCEPTED MANUSCRIPT Figure legend Legends:
RI PT
Figure 1A-C: Loosening zone measurement around the acetabular cup in anterior-posterior view (1A) [29,30] and around the femoral stem in anterior-posterior (1B) [28] and axial (1C) view [31], respectively.
SC
Figure 2: Follow-up flowchart
NU
Figure 3: Chrome and Cobalt values of all patients pre- and post-revision surgery
AC
CE
PT ED
MA
Figure 4: Metal ion trendline pre- and post-revision surgery
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Figure 1a
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Figure 1b
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Figure 1c
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AC
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Figure 2: Follow-up flowchart
MA
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Figure 3
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Figure 4
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