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CaP cement is equivalent to iliac bone graft in filling of large metaphyseal defects: 2 year prospective randomised study on distal radius osteotomies
Accepted Manuscript Title: CaP Cement is equivalent to Iliac Bone Graft in Filling of Large Metaphyseal Defects: 2 Year Prospective Randomised Study on Distal Radius Osteotomies Authors: Mona I. Winge, Magne Røkkum PII: DOI: Reference:
S0020-1383(17)30819-7 https://doi.org/10.1016/j.injury.2017.11.027 JINJ 7506
To appear in:
Injury, Int. J. Care Injured
Accepted date:
20-11-2017
Please cite this article as: Winge Mona I, Røkkum Magne.CaP Cement is equivalent to Iliac Bone Graft in Filling of Large Metaphyseal Defects: 2 Year Prospective Randomised Study on Distal Radius Osteotomies.Injury https://doi.org/10.1016/j.injury.2017.11.027 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.
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CaP Cement is equivalent to Iliac Bone Graft in Filling of Large Metaphyseal Defects: 2 Year Prospective Randomised Study on Distal Radius Osteotomies
Mona I. Winge MD1,2,3, Magne Røkkum MD PhD1,2 Division of Orthopaedic Surgery, Oslo University Hospital, Sognsvannsveien 20, 0372 Oslo,
Norway Institute of Clinical Medicine, University of Oslo, Oslo, Norway
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Corresponding author: [email protected]
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Tel: +47 23076001, Fax: +47 23076010
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Word count for abstract : 145
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Word count for main text : 2953 Number of tables : 3
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Number of figures : 10
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Abstract
The purpose of this prospective randomised study was to compare the clinical and
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radiological outcomes of injectable CaP bone cement with corticocancellous bone graft used to fill voids after corrective opening wedge osteotomies in the distal radius. 17 women/3 men, median age 56 (51.3; 61.0), underwent an open-wedge osteotomy of a dorsal malunion in the
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distal radius randomised to filling the defect either with bone graft (10) or CaP bone cement (10). Dorsal titanium locking plates were used and the wrist was plastered for 8 weeks. Follow-ups for 24 months included X-rays, CT scans, VAS on wrist and iliac crest, grip strength, ROM, Quick-DASH and Gartland & Werley scores. No difference was found between the 2 groups as to clinical outcome or radiological results with no loss of reduction.
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One bone graft patient developed a pseudarthrosis and one CaP patient suffered a plate fracture 6 months post-operatively. CaP bone cement is a good alternative to bone graft as a void filler in open-wedge osteotomies of the distal radius. The procedure is shorter, easier
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Level of Evidence Randomised controlled trial. Level I evidence.
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with the post-operative advantage of no donor site pain.
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Keywords Bone graft. Calcium phosphate bone cement. RCT. Xray. CT
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Introduction
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Malunion is an important complication after a distal radius fracture [1]. Symptomatic cases can be treated effectively with corrective osteotomies [1-5]. Defects have usually been filled
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with bone from the iliac crest [1-6] which is considered to be the gold standard for structural
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grafts [6]. Disadvantages such as donor site pain, haematomas, risk of infection and nerve injury may cause significant morbidity [7]. Injectable calcium phosphate (CaP) bone cement
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corresponds to the mineral phase of bone [8] and may be an alternative to bone grafting [912]. It is supposedly osteoconductive and animal observations imply gradual remodelling over time with later resorption and simultaneous replacement by bone [13]. CaP bone cement has
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been used in distal radius fracture treatment [14] and lately combined with corrective surgery of sequelae after radius fractures in the elderly with promising results [15, 16]. The purpose of this prospective randomised study was to compare the clinical and radiological outcomes of injectable CaP bone cement with corticocancellous bone graft used to fill voids after corrective opening wedge osteotomies in the distal radius.
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Materials and Methods The local ethics committee approved the study and the patients gave their informed consent to participate and randomisation after corrective osteotomy. A registration with clinical trials
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was made at a later date. Our null hypothesis stated that opening wedge osteotomies of the distal radius filled with CaP cement maintained their alignment as satisfactorily as
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osteotomies filled with corticocancellous bone grafts. The primary outcome was the
difference in volar angulation at 2 years. The secondary outcomes were the radiological
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parameters and functional scores. The inclusion criteria were distal radius malunion with
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dorsal deformity, disability and pain. The exclusion criteria were age under 18 years, ≥ ASA
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III, inflammatory arthritis and radio-carpal osteoarthritis. Randomisation was prepared by
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writing the two treatment options on papers and in a concealed manner were placed in an order generated manually folded and sealed in numbered envelopes impossible to disclose
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without opening.
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The same operation was performed on all patients. A tourniquet was applied before making a longitudinal dorsal skin incision over the third dorsal compartment and an oblique opening
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through the extensor retinaculum. The extensor pollicis longus (EPL) tendon was released and mobilised. The second and fourth compartments were dissected free subperiosteally, tendons held aside, Lister`s tubercle removed and the bone exposed. A thin k-wire was placed
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into the radio-carpal joint, a second was put parallel to the first one at the level of the osteotomy confirmed under fluoroscopy, determined as the site of maximum fracture displacement proximal to the radio-ulnar joint (Fig. 1). The osteotomy was done with an oscillating saw along the k-wire and perpendicular to the longitudinal axis of the radius while cooling down with water. The correction was done fluoroscopy-assisted with 2 distractors and
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with the healthy opposite wrist as a comparison. The optimal position was kept till the plate had been inserted. Temporary k-wires might be used. A titanium alloy LCP T-plate, 3.5 mm oblique-angled, (Synthes GmbH, Solothurn, Switzerland) was bent to fit the distal radius and fixed with angle locking screws. Pilot CT scans on a volunteer with titanium and steel plates attached to either wrist gave significantly less artefacts with titanium. Steel plates are the
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standard types of plates used in our unit.
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The patient was then randomised to fill the void with Norian® SRS (Skeletal Repair System,
Norian Corporation, Cupertino, CA, USA) CaP bone cement or a corticocancellous bone graft from the iliac crest. Norian® SRS consists of dry-mixed monocalcium phosphate,
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monohydrate [MCPM, Ca(H2PO4)2.H2O], α tricalcium phosphate [TCP, Ca3(PO4)2] and
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calcium carbonate (CC, CaCO3). A sodium phosphate solution is added until, within a few
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minutes, it forms a paste. It sets at 37° Celsius and its pH remains within the physiological
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range during the curing process. When it hardens it forms a carbonated hydroxyapatite i.e. dahlite by crystallisation [Ca8.8(HPO4)0.7(PO4)4.5(CO3)0.7(OH)1.3]. According to the
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manufacturer it reaches maximum resistance to compressive forces (55 MPa) in 12 hours,
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which is higher than cancellous bone and comparable to cortical bone. The tensile and shear forces are lower [13, 17, 18].
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The components of Norian® SRS were mixed together and injected immediately into the void, starting at the bottom and filling up the gap carefully to the surface (Fig. 2A). The tourniquet
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was released and after 10-12 minutes the bone cement had set. The iliac crest was anesthetised with Marcain® 0.5 % with adrenalin (Astra Zeneca, Oslo, Norway). The correct size corticocancellous bone block was formed and placed into the defect (Fig. 2B). The EPL was returned to its natural position over the dorsal plate taking care to minimise possible conflict with the metal by optimally shaping the distal end of the plate, tightening the screws
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completely and removing any loose CaP or bonegraft particles in near proximity. The extensor retinaculum was adapted with Vicryl® 3-0 and the skin was closed with Ethilon® 4-0. The arm was put in a cast for 8 weeks, changed after 2 weeks. A continuous brachial plexus block was administered as post-operative analgesia in 16/20 patients. The exceptions were one patient with lymphoedema, one with paresthesia in ulnar fingers, one in the radial fingers
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and one with signs of carpal tunnel syndrome which was released simultaneously.
Pre-operatively all patients underwent standard 90-90 posteroanterior and lateral X-rays (Figs.
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3A-B) of both wrists. X-rays of the operated wrist were taken post-operatively (Figs. 3C-D) and at 8 weeks, 3 – 6 – 12 and 24 months (Figs. 3E-F). CT-scans were obtained preoperatively and at all check-ups from 8 weeks with 0.625 mm thick slices reconstructed to 1
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mm. All images were digitalised and calibrated (PACS-Picture Archiving and
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Communication System, Sectra, Linköping, Sweden). Two investigators (MIW-MR) agreed
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on all cases. Ulna plus, radial inclination, volar angulation and radial length were measured
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[19, 20]. The distraction in the osteotomy gaps was determined on the dorsal and volar radial
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aspects of the 8 weeks lateral view. Radiological healing was defined as 3 continuous bone bridges overlapping the osteotomy gap on the X-rays or CT scans. Fixation failure would
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exclude a patient from further follow-up. We wish to present the post-operative CT scan
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remodelling in a separate article.
Pre-operatively the patients` overall health was examined, noting smoking habits and diabetes
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specifically. Functional evaluations were performed pre-operatively, at 2 - 8 weeks, 3 – 6 – 12 and 24 months. Pain at the wrist and iliac crest was assessed with a VAS from 0 to 10 where 0 indicated no pain. The grip strength was measured with JAMAR® dynamometer (J.A. 88 Preston Corp., Clifton, NJ, USA). Range of wrist motion (ROM) and forearm rotation were determined with a hand-held goniometer. The Gartland & Werley`s functional scoring system
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[20, 21] and the validated [22] and translated into norwegian Quick-DASH test [23] were completed.
Statistical analyses were performed with SPSS 17.0 (SPSS Norway AS, SPSS Inc., Chicago, USA) including independent sample t-test, non-parametric tests for independents samples i.e.
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Mann-Whitney and Kruskal-Wallis and two related sample test. The level of significance was set at 0.05. Data are presented as median with 25 and 75 percentiles. A power analysis was
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performed using a two-sample t-test, a level of significance at 0.05 and power of 0.90.
Clinical significance was set to a difference of 15 degrees of volar angulation, determining the
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need for eight patients in each group. Ten patients were chosen to be included in both groups.
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Results
From January 2007 to May 2009, 20 consecutive patients were included, one declined to
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participate. Patient characteristics are presented in Table 1.
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Seven wrist fractures were primarily intra-articular of which 6 were visible on the X-rays and 1 only on CT scan. One patient primarily treated with external fixator experienced an extensor
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indicis proprius rupture and needed a tendon transfer at the time of the osteotomy. Another patient was simultaneously treated for CMC1 osteoarthritis with trapeziectomy and tendon interposition. In the large opening-wedge osteotomies the titanium was noted to have a
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tendency to bend intra-operatively.
Eighteen osteotomies healed radiologically without tenderness to palpation (Table 2). One bone graft patient with some continuous wrist pain developed a pseudarthrosis in the proximal junction. X-rays and CT scans at 8 weeks, 3 months and an extra check-up at 4½ months
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verified this. Excision of the pseudarthrosis and cancellous bone grafting from the iliac crest with the dorsal plate still in place was done 6 months post-operatively, resulting in painless healing and good function. One CaP cement patient experienced dorsal tenderness from 4 months post-operatively, before she sustained a minor injury while making the bed 2 months later resulting in ulnar pain. A plate fracture was discovered at the 6-month follow-up (Fig. 4).
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Corticocancellous bone grafting from the iliac crest was done with a new dorsal plate. The
CaP cement was partly dissolved and granulated. She was excluded from further follow-up. In
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one bone graft patient the proximal junction healed at 3 months but the distal was open 3
more months. The two bone graft patients with insufficient bone healing were smokers whilst the CaP cement patient with plate fracture was not (Table 2). One CaP cement patient had
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diabetes type 2 and was operated with a wide distraction (Fig. 3-C-F). The osteotomy healed
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completely after 12 months.
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Post-operative radiographs showed the CaP cement as an opaque mass filling neatly the osteotomy gap. X-rays at 3-6 months showed radiolucent lines between the cement and bone,
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gradually filled with bone. At the one and two-year follow-up, new bone formation was seen
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within and around the CaP cement, which was partially fragmented (Figs.3-E-F). A new cortex was established along the entire osteotomy. The transition rate of the CaP cement to
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bone was slow and the majority of the cement was still present after two years. The same pattern of resorption and initial bone bridging along the surface of cement was observed in the
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one CaP cement patient who experienced a plate fracture at six months (Fig 4).
Two patients with bone grafts suffered EPL tendon ruptures at the distal edge of the plate 2 and 5 months post-operatively and needed indicis proprius transfers. The first patient also developed a pseudarthrosis and underwent simultaneous bone grafting. The second patient had a healed osteotomy and plate removal was combined with the tendon transfer. Twelve
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more patients (7 CaP cement and 5 bone graft) had plate removals done between 1 and 2 years due to local irritation from the plate and tenosynovitis-like symptoms. Some soft-tissue reaction was found around the plate and along the tendons in the areas of mechanical contact with the plate with similar findings in both groups. One CaP cement patient was operated just after 2 years with a triscaphoid fusion for osteoarthritis. The pain, registered at 24 months,
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could be referred to the triscaphoid joint and not the wrist.
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Table 2 shows the post-operative good alignment including corrections of the ulna plus, radial length, radial inclination and volar angulation, comparable to the non-operated wrist. No sustained difference between the operated groups pre- or post-operatively was found. At 24
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months the alignment was kept in both groups with no statistically significant change for any
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parameter in either group (p<0.05). Our null hypothesis was accepted.
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No functional dissimilarity was found between the groups (Table 3). The wrist pain fell
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significantly at 2 weeks (CaP cement p = 0.005; bone graft p = 0.018), and continued to fall at
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all later check-ups. The grip strength was significantly higher in the non-operated than the pre-operated wrists (CaP cement p = 0.008; bone graft p = 0.012). The level halved at 3
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months and returned to the same pre-operative strength from 6 months for both groups. The Gartland & Werley score fell significantly at 3 months (CaP cement p = 0.005; bone graft p =
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0.019) and stayed low. The Quick-DASH score fell gradually at every check-up in both groups, more slowly throughout the 24 months than the Gartland & Werley score. There was
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no difference between pre-operative ROM and 24 months as to flexion, extension or radial deviation. The only significant difference in both CaP cement and bone graft groups (p=0.011 & p=0.012) was the improved ulnar deviation. Supination was significantly worse in the CaP cement group pre-operatively (p = 0.035) but surgical correction normalised this at 24
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months. Hip pain was only noted at 2 weeks in the bone graft group (p= 0.011). All 20 patients would choose the same type of corrective surgery again.
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Discussion We found equivalent results using CaP bone cement and corticocancellous iliac crest bone
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grafts as gap fillers in opening wedge osteotomies in the distal radius. The post-operative alignment was unchanged after two years in both groups. This indicates that CaP cement retains its shape as well as corticocancellous bone grafts, consistent with the excellent
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resistance to compressive forces attributed to the bone cement. The radiological results in
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both groups were comparable to the contra-lateral wrist, confirming maintenance of the
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anatomical restoration.
The successful radiological incorporation of the 9 CaP cement osteotomies is underlined by
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the corresponding, favourable and lasting clinical results, including reduced pain, improved strength and functional scores, equally good for CaP and bone graft. Park experienced
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especially improved supination after corrective osteotomy, which correlates with our findings
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[24]. Others obtained improved flexion, extension and ulnar deviation [4, 15]. The ulnar deviation results are similar to ours. Tenosynovitis-like symptoms experienced by some patients in both groups might explain why Quick-DASH fell more slowly than the Gartland-
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Werley score.
Cigarette smoking in two bone graft patients may have contributed to one pseudarthrosis and one slow healing in the proximal osteotomy [25]. Diabetes type 2 might have delayed healing in one CaP patient [26].
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The shorter duration of surgery with bone cement was obviously due to the simpler procedure. The large surgical corrections caused probably equal amount of post-operative pain needing the same length of hospital stay. The positive aspect of using CaP cement was no donor site morbidity and pain.
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The gradual resorption of CaP cement and simultaneous new bone formation around the cement, bridging the proximal and distal radius across the osteotomy, are in accordance with
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the experimental findings of Frankenburg on dogs [13]. Remodelling of bone cement was
seen during the 2-year follow-up and a further process of new bone formation is expected to continue. The new bony connections in and around the CaP cement in 9/10 patients proved to
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resist the distractional, bending and shear forces experienced in everyday life. Our
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metaphyseal osteotomies with large surfaces of osteoblast-rich cancellous bone may be
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necessary for the integration and transformation of CaP cement into bone. It is uncertain
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whether smaller bone surfaces and the less active osteogenic bone will make it safe to use CaP cement in diaphyseal defects. We have also used CaP cement in the proximal humerus
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and radius, and it may be a good alternative in children, leaving the iliac crest untouched.
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Treatment of unstable distal radius fractures with injectable CaP cement without [14] or with insufficient [9] additional internal fixation led to loss of reduction. Supplemental skeletal
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fixation was recommended [27]. Luchetti treated six patients with a corrective osteotomy for dorsal radius malunion using CaP cement and K-wires [11]. His clinical results were satisfactory but some loss of reduction was experienced at average 33 months. Lozano-
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Calderon performed corrective radius osteotomies on six osteoporotic patients using CaP cement and fixed-angle plates [16]. All osteotomies healed. Radiological improvement from pre- to post-operative status was substantial, but no further information was given after an average follow-up of 16 months. Abramo observed no loss of correction at one year in 23/25
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patients operated for dorsal malunion with a buttress pin and radial pin plate [15]. One was lost to follow-up and one experienced no healing and a fracture at 2 months.
Titanium is more flexible than steel, and the plates were weakest just over the osteotomy, where they were probably exposed to the greatest bending forces. In one CaP patient bone
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healing was not strong enough before plate fracture at six months. Pre-fracture aching suggests unstable osteosynthesis consistent with insufficient fixation, which may also have
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caused the pseudarthrosis in one bone graft patient. Stronger designed titanium plates or steel
should be used for fixation of osteotomies with wide distractions. Both dorsal and volar distal radius plates cause tendon irritation [28-32]. The rupture incidence of EPL is reviewed
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systematically by Azzi [33]. Recommendations of careful follow-up and dorsal plate removal
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have been made [34]. Low-profile dorsal plates have not shown increased tendon irritation or
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rupture [35] and are recommended used for dorsally angulated fractures without
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compromising on the mechanical strength [36]. A cadaver study on simulated radial shaft osteotomies has demonstrated however the biomechanical superiority of a 3.5 mm plate with
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6 non-locking screws compared to a 2.7 mm with 8 locking screws [37].
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There is little detail in the literature concerning the size of the void created during openwedge osteotomies. Many seem to keep volar or dorsal cortical contact [15, 38], which is not
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the case for any of our patients (Table 1). The wide distractions need to be managed intra- and post-operatively more carefully than the small corrections where cortical contact is kept. The precise correction of the deformity, a stable plate fixation and regular follow-ups are
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important success criteria.
Reconstruction of dorsal malalignments with volar plates may be possible with small deformities requiring just an opening wedge osteotomy retaining the volar attachment without any lengthening [39]. This is rarely the case with severe deformities in our experience. Also
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the need for lengthening of the radius is difficult to ascertain before the osteotomy is performed. Some patients with small malalignments are maybe operated too early. Early and late reconstructive surgery show no difference in results [4], and the radiological alignment has only a minor influence on the long-term clinical outcome [40]. We found that dorsal access provides good control of large dorsal corrections as well as dependable and complete
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filling of the defect. Corrective osteotomies without a gap filler have been suggested in small corrections keeping volar cortical contact [41]. We would advise using a gap filler when no
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cortical contact is present between the bony parts.
A first limitation of this paper was the choice of plate. A titanium plate reduced the amount of
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artefacts on CT-scans but their weakness compared to steel plates became apparent during
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large distractions. Stronger titanium plates were not available at the time. This however
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permitted the observation of mechanical strengths of both void fillers. Secondly, the inclusion
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of only 10 patients in each group and possible skewed distribution of known and unknown
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parameters (f.ex. smoking) could be discussed. Although with a 2-year follow-up, the inclusion time needed and ability to reach results efficiently without loss to follow-up should
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be taken into account. Lastly the clinical and radiographical evaluations could have been carried out by a non-partisan examiner including blinded clinical examinations.
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The areas for future study and research are a histological examination of CaP bone cement in the operated area, long-term follow-up of CaP bone cement in near proximity to tendons, CaP
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bone cement combined with a good quality plate, post-operative casting compared to earlier mobilisation after corrective osteotomy and the use of CaP in children.
Conclusion
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The correction of radial malunions and severe deformities are possible with CaP cement, as a good alternative to bone graft. No loss of reduction was found at the 2-year follow-up. The procedure is shorter, easier, and has the post-operative advantage of no donor site pain. CaP bone cement would be a benefit as a choice in corrective osteotomies in children when the
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option of a larger bone graft from the cartilaginous iliac apophysis isn`t present.
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Conflict of interest
We declare that we have no conflict of interest in connection with this paper. All authors confirm that they have no financial and personal relationships with other people or
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organisations that could inappropriately influence (bias) this work.
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Acknowledgments
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Our acknowledgments go to Dr Ragnhild Gunderson (Department of Radiology,
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[29] Herron M, Faraj A, Craigen MA. Dorsal plating for displaced intra-articular fractures of the distal radius. Injury. 2003;34:497-502. [30] Hove LM, Nilsen PT, Furnes O, Oulie HE, Solheim E, Molster AO. Open reduction and internal fixation of displaced intraarticular fractures of the distal radius. 31 patients followed for 3-7 years. Acta Orthop Scand. 1997;68:59-63. [31] Gyuricza C, Carlson MG, Weiland AJ, Wolfe SW, Hotchkiss RN, Daluiski A. Removal of locked volar plates after distal radius fractures. J Hand Surg Am. 2011;36:982-5. [32] Rivlin M, Fernandez DL, Nagy L, Grana GL, Jupiter J. Extensor Pollicis Longus Ruptures Following Distal Radius Osteotomy Through a Volar Approach. J Hand Surg Am. 2016. [33] Azzi AJ, Aldekhayel S, Boehm KS, Zadeh T. Tendon Rupture and Tenosynovitis following Internal Fixation of Distal Radius Fractures: A Systematic Review. Plastic and reconstructive surgery. 2017;139:717e-24e. [34] Rein S, Schikore H, Schneiders W, Amlang M, Zwipp H. Results of dorsal or volar plate fixation of AO type C3 distal radius fractures: a retrospective study. J Hand Surg Am. 2007;32:954-61. [35] Yu YR, Makhni MC, Tabrizi S, Rozental TD, Mundanthanam G, Day CS. Complications of lowprofile dorsal versus volar locking plates in the distal radius: a comparative study. J Hand Surg Am. 2011;36:1135-41. [36] Kamath AF, Zurakowski D, Day CS. Low-profile dorsal plating for dorsally angulated distal radius fractures: an outcomes study. J Hand Surg Am. 2006;31:1061-7. [37] Garrigues GE, Glisson RR, Garrigues NW, Richard MJ, Ruch DS. Can locking screws allow smaller, low-profile plates to achieve comparable stability to larger, standard plates? J Orthop Trauma. 2011;25:347-54. [38] Sato K, Nakamura T, Iwamoto T, Toyama Y, Ikegami H, Takayama S. Corrective osteotomy for volarly malunited distal radius fracture. J Hand Surg Am. 2009;34:27-33, e1. [39] Rothenfluh E, Schweizer A, Nagy L. Opening wedge osteotomy for distal radius malunion: dorsal or palmar approach? J Wrist Surg. 2013;2:49-54. [40] Finsen V, Rod O, Rod K, Rajabi B, Alm-Paulsen PS, Russwurm H. The relationship between displacement and clinical outcome after distal radius (Colles') fracture. J Hand Surg Eur Vol. 2013;38:116-26. [41] Mahmoud M, El Shafie S, Kamal M. Correction of dorsally-malunited extra-articular distal radial fractures using volar locked plates without bone grafting. J Bone Joint Surg Br. 2012;94:1090-6.
Figure captions
Fig. 1. Placement of 2 parallel k-wires, the proximal one acting as a guide for the saw
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Fig. 2A. Opening wedge osteotomy with CaP bone cement and titanium dorsal plate Fig. 2B. Bone graft driven into the osteotomy gap under the titanium plate Fig. 3. Sixty-two year old female patient initially treated with closed reduction and cast for a distal radius fracture 13 months earlier. A-B. Pre-operative posteroanterior (PA) and lateral x-rays of right wrist, showing dorsal malunion. C-D. Post-operative PA and lateral views after
16
osteotomy, wide distraction and correction with CaP bone cement. E-F. PA and lateral views of right wrist 24 months after corrective osteotomy with CaP bone cement. No loss of reduction and signs of resorption of cement with simultaneous new bone formation within and around the cement visible. Fig. 4. Fifty-six year old female patient, PA view at 3 months, with a pattern of resorption
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ED
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A
N
U
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during the first 3-6 months, who experienced a plate fracture at six months.
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and initial bone bridging along the surface of cement, also observed in the other patients
A ED
PT
CC E
IP T
SC R
U
N
A
M
17
A ED
PT
CC E
IP T
SC R
U
N
A
M
18
A ED
PT
CC E
IP T
SC R
U
N
A
M
19
A ED
PT
CC E
IP T
SC R
U
N
A
M
20
A ED
PT
CC E
IP T
SC R
U
N
A
M
21
A ED
PT
CC E
IP T
SC R
U
N
A
M
22
A ED
PT
CC E
IP T
SC R
U
N
A
M
23
A ED
PT
CC E
IP T
SC R
U
N
A
M
24
A ED
PT
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IP T
SC R
U
N
A
M
25
26
Bone graft
10
10
56 (55.0; 60.5)
57 (45.5; 61.5)
Sex (n)
9F/1M
8F/2M
Dominant side
L0/R10
L2/R8
Affected side
L4/R6
L6/R4
Smokers (n)
1
4
Diabetes type 2 (n)
1
0
Primary fracture treatment (n) No reduction & cast Reduction & cast Reduction & cast + open reduction/bone graft/k-wires/cast External fixator
4 4 1 1
Intra-articular radius fractures (n)
4
Age (yrs; median, 25 and 75 % percentiles)
Intra-articular step (n) <1mm 1.2 mm Time fracture-osteotomy (yrs; median, 25 & 75 % percentiles) Operation length (minutes; median, 25 & 75 % percentiles) Hospitalisation (days; median, 25 & 75 % percentiles)
3 1
2 4 3 1
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Patients (n)
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Norian®
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128.0 (118.5; 151,3)
141.0 (128.8; 152.3)
N
U
1.7 (1.1; 2.4)
A
M
A
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Table 1. Patient characteristics
3
1.5 (0.9; 2.5)
3.0 (2.0; 3.0)
Void size (dorsal radial) (8 wks; mm; median; min-max; 25 & 75% percentiles) Void size (volar radial) (8 wks; mm; median; min-max; 25 & 75% percentiles)
3
3.0 (2.0; 4.0)
11.1 (8.3-22.7; 9.5,15.4)
11.8 (7.8-15.6; 9.8,13.8)
6.4 (4.3-16.1; 4.7,9.4)
7.1 (3.0-11.9; 6.0,9.8)
I
Non operated wrist ®
N
Norian Bone graft Norian Bone graft
Operated wrist
8 weeks 10
3 mths 10
6 mths 9
12 mths 9
24 mths 9
10
10
10
10*
10
10
3
5
1
2 0.0 (-0.8;0.0)
2** 0.0 (-1.0;0.3)
0.0 (-0.4;0.5)
1*** 0.0 (-0.8;0.5)
®
0.0 (-1.2;1.7)
3.6 (1.1;5.4)
®
1.2 (0.0;2.5) 11.8 (8.7;13.2)
4.5 (3.5;6.2) 9.0 (6.4;10.2)
0.4 (-0.9;1.3) 13.7 (11.9;14.9)
0.4 (-0.3;1.5) 13.4 (12.8;15.0)
0.9 (-0.3;1.7) 14.4 (12.1;15.3)
0.3 (0.0;1.7) 13.9 (12.7;15.4)
0.7 (-0.2;1.5) 13.8 (12.0;15.1)
11.9 (11.2;13.1)
9.3 (7.9;10.2)
12.8 (10.8;15.0)
12.9 (10.7;14.3)
12.5 (10.4;13.8)
12.8 (10.8;15.0)
12.7 (11.1;14.5)
25.8 (18.9;26.7)
18.8 (11.9;22.7)
28.2 (23.1;31.3)
29.6 (24.6;31.0)
29.9 (24.5;31.6)
29.5 (26.0;31.5)
29.4 (24.0;30.8)
24.7 (21.3;25.9)
19.6 (12.4;23.0)
25.4 (21.3;28.5)
24.7 (21.0;29.0)
23.7 (21.2;28.3)
25.0 (21.1;30.0)
25.5 (21.9;30.0)
12.6 (11.6;14.7)
-18.2 (-21.2;-9.0)
10.4 (5.5;13.9)
10.2 (5.0;12.4)
10.0 (5.4;14.0)
9.5 (6.2;14.5)
9.5 (6.4;14.3)
13.4 (11.9;15.0)
-15.8 (-28.1;-9.6)
9.4 (7.0;13.7)
9.7 (6.6;12.3)
10.9 (7.5;12.7)
10.4 (8.4;13.3)
9.9 (7.5;12.9)
Norian Bone graft
Radial length (mm)
Norian Bone graft ®
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Norian Bone graft ®
Volar angulation (degrees )
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5 0.0 (-1.0;0.3)
Ulna plus (mm)
Radial inclination (degrees)
Operated wrist
Pre-op 10
A
Radiological healing N
®
M
N
N U SC R
Non operated wrist
Norian Bone graft
A
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Table 2. Radiological results (median, 25 and 75 % percentiles) *1 pseudarthrosis reoperated at 6 months,**1 patient where healing was slower in proximal osteotomy than in distal, *** healed at 15 months (pseudarthrosis patient).
I Norian Bone graft
N Pain wrist (VAS)
®
Norian Bone graft Norian Bone graft
Grip strength (kg)
Norian Bone graft ®
Quick-DASH score
Norian Bone graft
Norian Bone graft ®
Norian Bone graft ®
Norian Bone graft
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Radial deviation
®
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Extension
Norian Bone graft
Ulnar deviation Pronation
A
Supination
31.0 (25.8;41.0)
ED
Gartland & Werley score
®
30.0 (21.5;38.5)
M
®
®
Norian Bone graft ®
Norian Bone graft ®
Norian Bone graft
Pre-op 10
2 weeks 10
3 mths 10
6 mths 9
12 mths 9
24 mths 9
10 6.0 (5.5;8.0)
10 3.0 (0.8;4.0)
10 3.0 (1.8;4.0)
10 2.5 (2.0;5.3)
10 3.0 (1.0;3.5)
10 2.0 (0.5;3.5)
10 1.0 (0.0;1.5)
5.0 (3.5;8.0)
2.0 (1.8;4.3)
4.0 (0.8;5.3)
3.0 (1.0;5.0)
3.5 (1.5;4.3)
2.5 (1.0;4.0)
0.0 (0.0;1.0)
0.0 (0.0;0.0)
0.0 (0.0;0.0)
0.0 (0.0;0.0)
0.0 (0.0;0.0)
0.0 0.0;0.0)
0.0 (0.0;0.0)
0.0 (0.0;0.0)
0.0 (0.0;0,0)
3.00 (1.5;3.3)a
0.0 (0.0;1.0)
0.0 (0.0;0.3)
0.0 (0.0;0.0)
0.0 (0.0;0.0.)
0.0 (0.0;0.0)
21.0 (14.5;26.5)
11.0 (7.5;14.3)
20.0 (10.5;22.5)
18.0 (16.0;23.0)
21.0 (12.5;29.0)
21.0 (15.3;40.5)
13.0 (7.0;20.5)
20.0 (14.0;35.0)
23.5 (15.8;35.0)
24.0 (18.0;32.5)
44.0 (29.5;51.1)
34.7 (27.1;43.1)
25.0 (12.5;33.6)
27.3 (9.2;38.7)
6.8 (2.3;17.7)
35.0 (21.3;66.5)
43.0 (22.2;55.6)
25.0 (14.2;35.0)
13.2 (6.8;39.8)
0.0 (0.0;6.9)
13.0 (10.8;15.0)
7.5 (5.5;10.0)
6.0 (4.0;6.0)
6.0 (3.5;6.0)
4.0 (2.0;4.5)
14.0 (7.8;16.3)
6.0 (4.0;10.5)
4.0 (3.5;7.0)
4.5 (2.8;6.0)
2.0 (1.0;4.0)
45.0 (35.0;50.0)
30.0 (19.5;42.5)
50.0 (37.0;51.0)
45.0 (40.0;50.0)
40.0 (35.0;58.0)
50.0 (38.8;62.5)
30.0 (20.0;46.3)
50.0 (39.0;65.0)
50.0 (40.0;62.5)
47.5(38.8.;59.5)
65.0 (50.0;75.0)
40.0 (30.0;46.3)
50.0 (45.0;60.0)
60.0 (52.5;63.0)
64.0 (52.0;67.5)
60.0 (47.5;72.5)
42.5 (20.0;50.0)
50.0 (40.0;60.0)
60.0 (52.5;60.5)
60.0 (55.0;65.0)
21.0 (18.8;25.0)
20.0 (10.0;22.8)
20.0 (17.5;26.0)
22.0 (18.0;30.0)
22.0 (20.0;32.0)
30.0 (20.0;30.0)
20.0 (12.0;25.0)
20.0 (20.0;27.5)
24.5 (20.0;30.0)
25.5 (23.5;30.0)
(15.0;31.5)b
22.5 (20.0;26.3)
35.0 (30.0;40.0)
36.0 (32.5;40.0)
40.0 (32.0;40.0)
27.5 (18.8;35.0)c
29.0 (23.8;35.0)
35.0 (30.0;40.0)
35.0 (30.0;40.0)
39.0 (30.5;40.0)
90.0 (78.8;90.0)
90.0 (71.3;90.0)
90.0 (90.0;90.0)
90.0 (90.0;90.0)
90.0 (90.0;90.0)
90.0 (88.8;90.0)
90.0 (80.0;90.0)
90.0 (90.0;90.0)
90.0 (90.0;90.0)
90.0 (90.0;90.0)
60.0 (43.8;90.0)
45.0 (36.3;90.0)
85.0 (55.0;90.0)
90.0 (57.5;90.0)
90.0 (70.0;90.0)
90.0 (83.8;90.0)
80.0 (52.5;86.3)
80.0 (80.0;90.0)
90.0 (83.8;90.0)
90.0 (90.0;90.0)
A
®
Pain hip (VAS)
Flexion
N U SC R
®
N
22.5
Table 3. Functional evaluation (median, 25 and 75 % percentiles) ® Statistically significant findings between Norian and bone graft at 2 weeks a p = 0.011 Statistically significant difference between pre-op and 24 mths b p = 0.011 c p = 0.012
8 weeks 10
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S0020-1383(17)30819-7 https://doi.org/10.1016/j.injury.2017.11.027 JINJ 7506
To appear in:
Injury, Int. J. Care Injured
Accepted date:
20-11-2017
Please cite this article as: Winge Mona I, Røkkum Magne.CaP Cement is equivalent to Iliac Bone Graft in Filling of Large Metaphyseal Defects: 2 Year Prospective Randomised Study on Distal Radius Osteotomies.Injury https://doi.org/10.1016/j.injury.2017.11.027 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.
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CaP Cement is equivalent to Iliac Bone Graft in Filling of Large Metaphyseal Defects: 2 Year Prospective Randomised Study on Distal Radius Osteotomies
Mona I. Winge MD1,2,3, Magne Røkkum MD PhD1,2 Division of Orthopaedic Surgery, Oslo University Hospital, Sognsvannsveien 20, 0372 Oslo,
Norway Institute of Clinical Medicine, University of Oslo, Oslo, Norway
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Corresponding author: [email protected]
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Tel: +47 23076001, Fax: +47 23076010
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Word count for abstract : 145
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Word count for main text : 2953 Number of tables : 3
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Number of figures : 10
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Abstract
The purpose of this prospective randomised study was to compare the clinical and
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radiological outcomes of injectable CaP bone cement with corticocancellous bone graft used to fill voids after corrective opening wedge osteotomies in the distal radius. 17 women/3 men, median age 56 (51.3; 61.0), underwent an open-wedge osteotomy of a dorsal malunion in the
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distal radius randomised to filling the defect either with bone graft (10) or CaP bone cement (10). Dorsal titanium locking plates were used and the wrist was plastered for 8 weeks. Follow-ups for 24 months included X-rays, CT scans, VAS on wrist and iliac crest, grip strength, ROM, Quick-DASH and Gartland & Werley scores. No difference was found between the 2 groups as to clinical outcome or radiological results with no loss of reduction.
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One bone graft patient developed a pseudarthrosis and one CaP patient suffered a plate fracture 6 months post-operatively. CaP bone cement is a good alternative to bone graft as a void filler in open-wedge osteotomies of the distal radius. The procedure is shorter, easier
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Level of Evidence Randomised controlled trial. Level I evidence.
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with the post-operative advantage of no donor site pain.
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Keywords Bone graft. Calcium phosphate bone cement. RCT. Xray. CT
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Introduction
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Malunion is an important complication after a distal radius fracture [1]. Symptomatic cases can be treated effectively with corrective osteotomies [1-5]. Defects have usually been filled
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with bone from the iliac crest [1-6] which is considered to be the gold standard for structural
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grafts [6]. Disadvantages such as donor site pain, haematomas, risk of infection and nerve injury may cause significant morbidity [7]. Injectable calcium phosphate (CaP) bone cement
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corresponds to the mineral phase of bone [8] and may be an alternative to bone grafting [912]. It is supposedly osteoconductive and animal observations imply gradual remodelling over time with later resorption and simultaneous replacement by bone [13]. CaP bone cement has
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been used in distal radius fracture treatment [14] and lately combined with corrective surgery of sequelae after radius fractures in the elderly with promising results [15, 16]. The purpose of this prospective randomised study was to compare the clinical and radiological outcomes of injectable CaP bone cement with corticocancellous bone graft used to fill voids after corrective opening wedge osteotomies in the distal radius.
3
Materials and Methods The local ethics committee approved the study and the patients gave their informed consent to participate and randomisation after corrective osteotomy. A registration with clinical trials
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was made at a later date. Our null hypothesis stated that opening wedge osteotomies of the distal radius filled with CaP cement maintained their alignment as satisfactorily as
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osteotomies filled with corticocancellous bone grafts. The primary outcome was the
difference in volar angulation at 2 years. The secondary outcomes were the radiological
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parameters and functional scores. The inclusion criteria were distal radius malunion with
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dorsal deformity, disability and pain. The exclusion criteria were age under 18 years, ≥ ASA
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III, inflammatory arthritis and radio-carpal osteoarthritis. Randomisation was prepared by
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writing the two treatment options on papers and in a concealed manner were placed in an order generated manually folded and sealed in numbered envelopes impossible to disclose
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without opening.
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The same operation was performed on all patients. A tourniquet was applied before making a longitudinal dorsal skin incision over the third dorsal compartment and an oblique opening
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through the extensor retinaculum. The extensor pollicis longus (EPL) tendon was released and mobilised. The second and fourth compartments were dissected free subperiosteally, tendons held aside, Lister`s tubercle removed and the bone exposed. A thin k-wire was placed
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into the radio-carpal joint, a second was put parallel to the first one at the level of the osteotomy confirmed under fluoroscopy, determined as the site of maximum fracture displacement proximal to the radio-ulnar joint (Fig. 1). The osteotomy was done with an oscillating saw along the k-wire and perpendicular to the longitudinal axis of the radius while cooling down with water. The correction was done fluoroscopy-assisted with 2 distractors and
4
with the healthy opposite wrist as a comparison. The optimal position was kept till the plate had been inserted. Temporary k-wires might be used. A titanium alloy LCP T-plate, 3.5 mm oblique-angled, (Synthes GmbH, Solothurn, Switzerland) was bent to fit the distal radius and fixed with angle locking screws. Pilot CT scans on a volunteer with titanium and steel plates attached to either wrist gave significantly less artefacts with titanium. Steel plates are the
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standard types of plates used in our unit.
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The patient was then randomised to fill the void with Norian® SRS (Skeletal Repair System,
Norian Corporation, Cupertino, CA, USA) CaP bone cement or a corticocancellous bone graft from the iliac crest. Norian® SRS consists of dry-mixed monocalcium phosphate,
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monohydrate [MCPM, Ca(H2PO4)2.H2O], α tricalcium phosphate [TCP, Ca3(PO4)2] and
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calcium carbonate (CC, CaCO3). A sodium phosphate solution is added until, within a few
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minutes, it forms a paste. It sets at 37° Celsius and its pH remains within the physiological
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range during the curing process. When it hardens it forms a carbonated hydroxyapatite i.e. dahlite by crystallisation [Ca8.8(HPO4)0.7(PO4)4.5(CO3)0.7(OH)1.3]. According to the
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manufacturer it reaches maximum resistance to compressive forces (55 MPa) in 12 hours,
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which is higher than cancellous bone and comparable to cortical bone. The tensile and shear forces are lower [13, 17, 18].
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The components of Norian® SRS were mixed together and injected immediately into the void, starting at the bottom and filling up the gap carefully to the surface (Fig. 2A). The tourniquet
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was released and after 10-12 minutes the bone cement had set. The iliac crest was anesthetised with Marcain® 0.5 % with adrenalin (Astra Zeneca, Oslo, Norway). The correct size corticocancellous bone block was formed and placed into the defect (Fig. 2B). The EPL was returned to its natural position over the dorsal plate taking care to minimise possible conflict with the metal by optimally shaping the distal end of the plate, tightening the screws
5
completely and removing any loose CaP or bonegraft particles in near proximity. The extensor retinaculum was adapted with Vicryl® 3-0 and the skin was closed with Ethilon® 4-0. The arm was put in a cast for 8 weeks, changed after 2 weeks. A continuous brachial plexus block was administered as post-operative analgesia in 16/20 patients. The exceptions were one patient with lymphoedema, one with paresthesia in ulnar fingers, one in the radial fingers
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and one with signs of carpal tunnel syndrome which was released simultaneously.
Pre-operatively all patients underwent standard 90-90 posteroanterior and lateral X-rays (Figs.
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3A-B) of both wrists. X-rays of the operated wrist were taken post-operatively (Figs. 3C-D) and at 8 weeks, 3 – 6 – 12 and 24 months (Figs. 3E-F). CT-scans were obtained preoperatively and at all check-ups from 8 weeks with 0.625 mm thick slices reconstructed to 1
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mm. All images were digitalised and calibrated (PACS-Picture Archiving and
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Communication System, Sectra, Linköping, Sweden). Two investigators (MIW-MR) agreed
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on all cases. Ulna plus, radial inclination, volar angulation and radial length were measured
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[19, 20]. The distraction in the osteotomy gaps was determined on the dorsal and volar radial
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aspects of the 8 weeks lateral view. Radiological healing was defined as 3 continuous bone bridges overlapping the osteotomy gap on the X-rays or CT scans. Fixation failure would
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exclude a patient from further follow-up. We wish to present the post-operative CT scan
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remodelling in a separate article.
Pre-operatively the patients` overall health was examined, noting smoking habits and diabetes
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specifically. Functional evaluations were performed pre-operatively, at 2 - 8 weeks, 3 – 6 – 12 and 24 months. Pain at the wrist and iliac crest was assessed with a VAS from 0 to 10 where 0 indicated no pain. The grip strength was measured with JAMAR® dynamometer (J.A. 88 Preston Corp., Clifton, NJ, USA). Range of wrist motion (ROM) and forearm rotation were determined with a hand-held goniometer. The Gartland & Werley`s functional scoring system
6
[20, 21] and the validated [22] and translated into norwegian Quick-DASH test [23] were completed.
Statistical analyses were performed with SPSS 17.0 (SPSS Norway AS, SPSS Inc., Chicago, USA) including independent sample t-test, non-parametric tests for independents samples i.e.
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Mann-Whitney and Kruskal-Wallis and two related sample test. The level of significance was set at 0.05. Data are presented as median with 25 and 75 percentiles. A power analysis was
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performed using a two-sample t-test, a level of significance at 0.05 and power of 0.90.
Clinical significance was set to a difference of 15 degrees of volar angulation, determining the
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need for eight patients in each group. Ten patients were chosen to be included in both groups.
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Results
From January 2007 to May 2009, 20 consecutive patients were included, one declined to
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participate. Patient characteristics are presented in Table 1.
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Seven wrist fractures were primarily intra-articular of which 6 were visible on the X-rays and 1 only on CT scan. One patient primarily treated with external fixator experienced an extensor
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indicis proprius rupture and needed a tendon transfer at the time of the osteotomy. Another patient was simultaneously treated for CMC1 osteoarthritis with trapeziectomy and tendon interposition. In the large opening-wedge osteotomies the titanium was noted to have a
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tendency to bend intra-operatively.
Eighteen osteotomies healed radiologically without tenderness to palpation (Table 2). One bone graft patient with some continuous wrist pain developed a pseudarthrosis in the proximal junction. X-rays and CT scans at 8 weeks, 3 months and an extra check-up at 4½ months
7
verified this. Excision of the pseudarthrosis and cancellous bone grafting from the iliac crest with the dorsal plate still in place was done 6 months post-operatively, resulting in painless healing and good function. One CaP cement patient experienced dorsal tenderness from 4 months post-operatively, before she sustained a minor injury while making the bed 2 months later resulting in ulnar pain. A plate fracture was discovered at the 6-month follow-up (Fig. 4).
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Corticocancellous bone grafting from the iliac crest was done with a new dorsal plate. The
CaP cement was partly dissolved and granulated. She was excluded from further follow-up. In
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one bone graft patient the proximal junction healed at 3 months but the distal was open 3
more months. The two bone graft patients with insufficient bone healing were smokers whilst the CaP cement patient with plate fracture was not (Table 2). One CaP cement patient had
U
diabetes type 2 and was operated with a wide distraction (Fig. 3-C-F). The osteotomy healed
A
N
completely after 12 months.
M
Post-operative radiographs showed the CaP cement as an opaque mass filling neatly the osteotomy gap. X-rays at 3-6 months showed radiolucent lines between the cement and bone,
ED
gradually filled with bone. At the one and two-year follow-up, new bone formation was seen
PT
within and around the CaP cement, which was partially fragmented (Figs.3-E-F). A new cortex was established along the entire osteotomy. The transition rate of the CaP cement to
CC E
bone was slow and the majority of the cement was still present after two years. The same pattern of resorption and initial bone bridging along the surface of cement was observed in the
A
one CaP cement patient who experienced a plate fracture at six months (Fig 4).
Two patients with bone grafts suffered EPL tendon ruptures at the distal edge of the plate 2 and 5 months post-operatively and needed indicis proprius transfers. The first patient also developed a pseudarthrosis and underwent simultaneous bone grafting. The second patient had a healed osteotomy and plate removal was combined with the tendon transfer. Twelve
8
more patients (7 CaP cement and 5 bone graft) had plate removals done between 1 and 2 years due to local irritation from the plate and tenosynovitis-like symptoms. Some soft-tissue reaction was found around the plate and along the tendons in the areas of mechanical contact with the plate with similar findings in both groups. One CaP cement patient was operated just after 2 years with a triscaphoid fusion for osteoarthritis. The pain, registered at 24 months,
IP T
could be referred to the triscaphoid joint and not the wrist.
SC R
Table 2 shows the post-operative good alignment including corrections of the ulna plus, radial length, radial inclination and volar angulation, comparable to the non-operated wrist. No sustained difference between the operated groups pre- or post-operatively was found. At 24
U
months the alignment was kept in both groups with no statistically significant change for any
N
parameter in either group (p<0.05). Our null hypothesis was accepted.
A
No functional dissimilarity was found between the groups (Table 3). The wrist pain fell
M
significantly at 2 weeks (CaP cement p = 0.005; bone graft p = 0.018), and continued to fall at
ED
all later check-ups. The grip strength was significantly higher in the non-operated than the pre-operated wrists (CaP cement p = 0.008; bone graft p = 0.012). The level halved at 3
PT
months and returned to the same pre-operative strength from 6 months for both groups. The Gartland & Werley score fell significantly at 3 months (CaP cement p = 0.005; bone graft p =
CC E
0.019) and stayed low. The Quick-DASH score fell gradually at every check-up in both groups, more slowly throughout the 24 months than the Gartland & Werley score. There was
A
no difference between pre-operative ROM and 24 months as to flexion, extension or radial deviation. The only significant difference in both CaP cement and bone graft groups (p=0.011 & p=0.012) was the improved ulnar deviation. Supination was significantly worse in the CaP cement group pre-operatively (p = 0.035) but surgical correction normalised this at 24
9
months. Hip pain was only noted at 2 weeks in the bone graft group (p= 0.011). All 20 patients would choose the same type of corrective surgery again.
IP T
Discussion We found equivalent results using CaP bone cement and corticocancellous iliac crest bone
SC R
grafts as gap fillers in opening wedge osteotomies in the distal radius. The post-operative alignment was unchanged after two years in both groups. This indicates that CaP cement retains its shape as well as corticocancellous bone grafts, consistent with the excellent
U
resistance to compressive forces attributed to the bone cement. The radiological results in
N
both groups were comparable to the contra-lateral wrist, confirming maintenance of the
M
A
anatomical restoration.
The successful radiological incorporation of the 9 CaP cement osteotomies is underlined by
ED
the corresponding, favourable and lasting clinical results, including reduced pain, improved strength and functional scores, equally good for CaP and bone graft. Park experienced
PT
especially improved supination after corrective osteotomy, which correlates with our findings
CC E
[24]. Others obtained improved flexion, extension and ulnar deviation [4, 15]. The ulnar deviation results are similar to ours. Tenosynovitis-like symptoms experienced by some patients in both groups might explain why Quick-DASH fell more slowly than the Gartland-
A
Werley score.
Cigarette smoking in two bone graft patients may have contributed to one pseudarthrosis and one slow healing in the proximal osteotomy [25]. Diabetes type 2 might have delayed healing in one CaP patient [26].
10
The shorter duration of surgery with bone cement was obviously due to the simpler procedure. The large surgical corrections caused probably equal amount of post-operative pain needing the same length of hospital stay. The positive aspect of using CaP cement was no donor site morbidity and pain.
IP T
The gradual resorption of CaP cement and simultaneous new bone formation around the cement, bridging the proximal and distal radius across the osteotomy, are in accordance with
SC R
the experimental findings of Frankenburg on dogs [13]. Remodelling of bone cement was
seen during the 2-year follow-up and a further process of new bone formation is expected to continue. The new bony connections in and around the CaP cement in 9/10 patients proved to
U
resist the distractional, bending and shear forces experienced in everyday life. Our
N
metaphyseal osteotomies with large surfaces of osteoblast-rich cancellous bone may be
A
necessary for the integration and transformation of CaP cement into bone. It is uncertain
M
whether smaller bone surfaces and the less active osteogenic bone will make it safe to use CaP cement in diaphyseal defects. We have also used CaP cement in the proximal humerus
ED
and radius, and it may be a good alternative in children, leaving the iliac crest untouched.
PT
Treatment of unstable distal radius fractures with injectable CaP cement without [14] or with insufficient [9] additional internal fixation led to loss of reduction. Supplemental skeletal
CC E
fixation was recommended [27]. Luchetti treated six patients with a corrective osteotomy for dorsal radius malunion using CaP cement and K-wires [11]. His clinical results were satisfactory but some loss of reduction was experienced at average 33 months. Lozano-
A
Calderon performed corrective radius osteotomies on six osteoporotic patients using CaP cement and fixed-angle plates [16]. All osteotomies healed. Radiological improvement from pre- to post-operative status was substantial, but no further information was given after an average follow-up of 16 months. Abramo observed no loss of correction at one year in 23/25
11
patients operated for dorsal malunion with a buttress pin and radial pin plate [15]. One was lost to follow-up and one experienced no healing and a fracture at 2 months.
Titanium is more flexible than steel, and the plates were weakest just over the osteotomy, where they were probably exposed to the greatest bending forces. In one CaP patient bone
IP T
healing was not strong enough before plate fracture at six months. Pre-fracture aching suggests unstable osteosynthesis consistent with insufficient fixation, which may also have
SC R
caused the pseudarthrosis in one bone graft patient. Stronger designed titanium plates or steel
should be used for fixation of osteotomies with wide distractions. Both dorsal and volar distal radius plates cause tendon irritation [28-32]. The rupture incidence of EPL is reviewed
U
systematically by Azzi [33]. Recommendations of careful follow-up and dorsal plate removal
N
have been made [34]. Low-profile dorsal plates have not shown increased tendon irritation or
A
rupture [35] and are recommended used for dorsally angulated fractures without
M
compromising on the mechanical strength [36]. A cadaver study on simulated radial shaft osteotomies has demonstrated however the biomechanical superiority of a 3.5 mm plate with
ED
6 non-locking screws compared to a 2.7 mm with 8 locking screws [37].
PT
There is little detail in the literature concerning the size of the void created during openwedge osteotomies. Many seem to keep volar or dorsal cortical contact [15, 38], which is not
CC E
the case for any of our patients (Table 1). The wide distractions need to be managed intra- and post-operatively more carefully than the small corrections where cortical contact is kept. The precise correction of the deformity, a stable plate fixation and regular follow-ups are
A
important success criteria.
Reconstruction of dorsal malalignments with volar plates may be possible with small deformities requiring just an opening wedge osteotomy retaining the volar attachment without any lengthening [39]. This is rarely the case with severe deformities in our experience. Also
12
the need for lengthening of the radius is difficult to ascertain before the osteotomy is performed. Some patients with small malalignments are maybe operated too early. Early and late reconstructive surgery show no difference in results [4], and the radiological alignment has only a minor influence on the long-term clinical outcome [40]. We found that dorsal access provides good control of large dorsal corrections as well as dependable and complete
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filling of the defect. Corrective osteotomies without a gap filler have been suggested in small corrections keeping volar cortical contact [41]. We would advise using a gap filler when no
SC R
cortical contact is present between the bony parts.
A first limitation of this paper was the choice of plate. A titanium plate reduced the amount of
U
artefacts on CT-scans but their weakness compared to steel plates became apparent during
N
large distractions. Stronger titanium plates were not available at the time. This however
A
permitted the observation of mechanical strengths of both void fillers. Secondly, the inclusion
M
of only 10 patients in each group and possible skewed distribution of known and unknown
ED
parameters (f.ex. smoking) could be discussed. Although with a 2-year follow-up, the inclusion time needed and ability to reach results efficiently without loss to follow-up should
PT
be taken into account. Lastly the clinical and radiographical evaluations could have been carried out by a non-partisan examiner including blinded clinical examinations.
CC E
The areas for future study and research are a histological examination of CaP bone cement in the operated area, long-term follow-up of CaP bone cement in near proximity to tendons, CaP
A
bone cement combined with a good quality plate, post-operative casting compared to earlier mobilisation after corrective osteotomy and the use of CaP in children.
Conclusion
13
The correction of radial malunions and severe deformities are possible with CaP cement, as a good alternative to bone graft. No loss of reduction was found at the 2-year follow-up. The procedure is shorter, easier, and has the post-operative advantage of no donor site pain. CaP bone cement would be a benefit as a choice in corrective osteotomies in children when the
IP T
option of a larger bone graft from the cartilaginous iliac apophysis isn`t present.
SC R
Conflict of interest
We declare that we have no conflict of interest in connection with this paper. All authors confirm that they have no financial and personal relationships with other people or
A
N
U
organisations that could inappropriately influence (bias) this work.
M
Acknowledgments
ED
Our acknowledgments go to Dr Ragnhild Gunderson (Department of Radiology,
CC E
References
PT
Rikshospitalet, Oslo University Hospital)
A
[1] Fernandez DL, Ring D, Jupiter JB. Surgical management of delayed union and nonunion of distal radius fractures. J Hand Surg Am. 2001;26:201-9. [2] Fernandez DL. Correction of post-traumatic wrist deformity in adults by osteotomy, bone-grafting, and internal fixation. J Bone Joint Surg Am. 1982;64:1164-78. [3] af Ekenstam F, Hagert CG, Engkvist O, Tornvall AH, Wilbrand H. Corrective osteotomy of malunited fractures of the distal end of the radius. Scand J Plast Reconstr Surg. 1985;19:175-87. [4] Jupiter JB, Ring D. A comparison of early and late reconstruction of malunited fractures of the distal end of the radius. J Bone Joint Surg Am. 1996;78:739-48. [5] Amadio PC, Botte MJ. Treatment of malunion of the distal radius. Hand Clin. 1987;3:541-61. [6] De Long WG, Jr., Einhorn TA, Koval K, McKee M, Smith W, Sanders R, et al. Bone grafts and bone graft substitutes in orthopaedic trauma surgery. A critical analysis. J Bone Joint Surg Am. 2007;89:649-58.
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[7] Arrington ED, Smith WJ, Chambers HG, Bucknell AL, Davino NA. Complications of iliac crest bone graft harvesting. Clin Orthop Relat Res. 1996:300-9. [8] Constantz BR, Ison IC, Fulmer MT, Poser RD, Smith ST, VanWagoner M, et al. Skeletal repair by in situ formation of the mineral phase of bone. Science. 1995;267:1796-9. [9] Gangopadhyay S, Ravi K, Packer G. Dorsal plating of unstable distal radius fractures using a bioabsorbable plating system and bone substitute. J Hand Surg Br. 2006;31:93-100. [10] Sennwald G, Della Santa D. [Utility of bone substitutes: study of 101 distal radius fractures]. Chir Main. 2001;20:454-7. [11] Luchetti R. Corrective osteotomy of malunited distal radius fractures using carbonated hydroxyapatite as an alternative to autogenous bone grafting. J Hand Surg Am. 2004;29:825-34. [12] Winge MI, Reikeras O, Rokkum M. Calcium phosphate bone cement: a possible alternative to autologous bone graft. A radiological and biomechanical comparison in rat tibial bone. Arch Orthop Trauma Surg. 2011;131:1035-41. [13] Frankenburg EP, Goldstein SA, Bauer TW, Harris SA, Poser RD. Biomechanical and histological evaluation of a calcium phosphate cement. J Bone Joint Surg Am. 1998;80:1112-24. [14] Kopylov P, Adalberth K, Jonsson K, Aspenberg P. Norian SRS versus functional treatment in redisplaced distal radial fractures: a randomized study in 20 patients. J Hand Surg Br. 2002;27:538-41. [15] Abramo A, Tagil M, Geijer M, Kopylov P. Osteotomy of dorsally displaced malunited fractures of the distal radius: no loss of radiographic correction during healing with a minimally invasive fixation technique and an injectable bone substitute. Acta Orthop. 2008;79:262-8. [16] Lozano-Calderon S, Moore M, Liebman M, Jupiter JB. Distal radius osteotomy in the elderly patient using angular stable implants and Norian bone cement. J Hand Surg Am. 2007;32:976-83. [17] Goodman SB, Bauer TW, Carter D, Casteleyn PP, Goldstein SA, Kyle RF, et al. Norian SRS cement augmentation in hip fracture treatment. Laboratory and initial clinical results. Clin Orthop Relat Res. 1998:42-50. [18] Mattsson P, Alberts A, Dahlberg G, Sohlman M, Hyldahl HC, Larsson S. Resorbable cement for the augmentation of internally-fixed unstable trochanteric fractures. A prospective, randomised multicentre study. J Bone Joint Surg Br. 2005;87:1203-9. [19] Mishra PK, Nagar M, Gaur SC, Gupta A. Morphometry of distal end radius in the Indian population: A radiological study. Indian journal of orthopaedics. 2016;50:610-5. [20] Gartland JJ, Jr., Werley CW. Evaluation of healed Colles' fractures. J Bone Joint Surg Am. 1951;33A:895-907. [21] Souer JS, Lozano-Calderon SA, Ring D. Predictors of wrist function and health status after operative treatment of fractures of the distal radius. J Hand Surg Am. 2008;33:157-63. [22] Liem IS, Kolling C, Marks M, Nelissen RG, Goldhahn J. Development of a score set to measure function and quality of life in patients suffering from elbow pathology. Arch Orthop Trauma Surg. 2012;132:831-7. [23] Finsen V. [Norwegian version of the DASH questionnaire for examination of the arm shoulders and hand]. Tidsskr Nor Laegeforen. 2008;128:1070. [24] Park MJ, Lee YB, Kim HG. Surgical correction for supination loss following malunited radial fractures. Acta Orthop Belg. 2012;78:175-82. [25] Moghaddam A, Zimmermann G, Hammer K, Bruckner T, Grutzner PA, von Recum J. Cigarette smoking influences the clinical and occupational outcome of patients with tibial shaft fractures. Injury. 2011;42:1435-42. [26] Pscherer S, Sandmann GH, Ehnert S, Nussler AK, Stockle U, Freude T. Delayed Fracture Healing in Diabetics with Distal Radius Fractures. Acta Chir Orthop Traumatol Cech. 2015;82:268-73. [27] Higgins TF, Dodds SD, Wolfe SW. A biomechanical analysis of fixation of intra-articular distal radial fractures with calcium-phosphate bone cement. J Bone Joint Surg Am. 2002;84-A:1579-86. [28] Lozano-Calderon SA, Brouwer KM, Doornberg JN, Goslings JC, Kloen P, Jupiter JB. Long-term outcomes of corrective osteotomy for the treatment of distal radius malunion. J Hand Surg Eur Vol. 2010;35:370-80.
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[29] Herron M, Faraj A, Craigen MA. Dorsal plating for displaced intra-articular fractures of the distal radius. Injury. 2003;34:497-502. [30] Hove LM, Nilsen PT, Furnes O, Oulie HE, Solheim E, Molster AO. Open reduction and internal fixation of displaced intraarticular fractures of the distal radius. 31 patients followed for 3-7 years. Acta Orthop Scand. 1997;68:59-63. [31] Gyuricza C, Carlson MG, Weiland AJ, Wolfe SW, Hotchkiss RN, Daluiski A. Removal of locked volar plates after distal radius fractures. J Hand Surg Am. 2011;36:982-5. [32] Rivlin M, Fernandez DL, Nagy L, Grana GL, Jupiter J. Extensor Pollicis Longus Ruptures Following Distal Radius Osteotomy Through a Volar Approach. J Hand Surg Am. 2016. [33] Azzi AJ, Aldekhayel S, Boehm KS, Zadeh T. Tendon Rupture and Tenosynovitis following Internal Fixation of Distal Radius Fractures: A Systematic Review. Plastic and reconstructive surgery. 2017;139:717e-24e. [34] Rein S, Schikore H, Schneiders W, Amlang M, Zwipp H. Results of dorsal or volar plate fixation of AO type C3 distal radius fractures: a retrospective study. J Hand Surg Am. 2007;32:954-61. [35] Yu YR, Makhni MC, Tabrizi S, Rozental TD, Mundanthanam G, Day CS. Complications of lowprofile dorsal versus volar locking plates in the distal radius: a comparative study. J Hand Surg Am. 2011;36:1135-41. [36] Kamath AF, Zurakowski D, Day CS. Low-profile dorsal plating for dorsally angulated distal radius fractures: an outcomes study. J Hand Surg Am. 2006;31:1061-7. [37] Garrigues GE, Glisson RR, Garrigues NW, Richard MJ, Ruch DS. Can locking screws allow smaller, low-profile plates to achieve comparable stability to larger, standard plates? J Orthop Trauma. 2011;25:347-54. [38] Sato K, Nakamura T, Iwamoto T, Toyama Y, Ikegami H, Takayama S. Corrective osteotomy for volarly malunited distal radius fracture. J Hand Surg Am. 2009;34:27-33, e1. [39] Rothenfluh E, Schweizer A, Nagy L. Opening wedge osteotomy for distal radius malunion: dorsal or palmar approach? J Wrist Surg. 2013;2:49-54. [40] Finsen V, Rod O, Rod K, Rajabi B, Alm-Paulsen PS, Russwurm H. The relationship between displacement and clinical outcome after distal radius (Colles') fracture. J Hand Surg Eur Vol. 2013;38:116-26. [41] Mahmoud M, El Shafie S, Kamal M. Correction of dorsally-malunited extra-articular distal radial fractures using volar locked plates without bone grafting. J Bone Joint Surg Br. 2012;94:1090-6.
Figure captions
Fig. 1. Placement of 2 parallel k-wires, the proximal one acting as a guide for the saw
A
Fig. 2A. Opening wedge osteotomy with CaP bone cement and titanium dorsal plate Fig. 2B. Bone graft driven into the osteotomy gap under the titanium plate Fig. 3. Sixty-two year old female patient initially treated with closed reduction and cast for a distal radius fracture 13 months earlier. A-B. Pre-operative posteroanterior (PA) and lateral x-rays of right wrist, showing dorsal malunion. C-D. Post-operative PA and lateral views after
16
osteotomy, wide distraction and correction with CaP bone cement. E-F. PA and lateral views of right wrist 24 months after corrective osteotomy with CaP bone cement. No loss of reduction and signs of resorption of cement with simultaneous new bone formation within and around the cement visible. Fig. 4. Fifty-six year old female patient, PA view at 3 months, with a pattern of resorption
A
CC E
PT
ED
M
A
N
U
SC R
during the first 3-6 months, who experienced a plate fracture at six months.
IP T
and initial bone bridging along the surface of cement, also observed in the other patients
A ED
PT
CC E
IP T
SC R
U
N
A
M
17
A ED
PT
CC E
IP T
SC R
U
N
A
M
18
A ED
PT
CC E
IP T
SC R
U
N
A
M
19
A ED
PT
CC E
IP T
SC R
U
N
A
M
20
A ED
PT
CC E
IP T
SC R
U
N
A
M
21
A ED
PT
CC E
IP T
SC R
U
N
A
M
22
A ED
PT
CC E
IP T
SC R
U
N
A
M
23
A ED
PT
CC E
IP T
SC R
U
N
A
M
24
A ED
PT
CC E
IP T
SC R
U
N
A
M
25
26
Bone graft
10
10
56 (55.0; 60.5)
57 (45.5; 61.5)
Sex (n)
9F/1M
8F/2M
Dominant side
L0/R10
L2/R8
Affected side
L4/R6
L6/R4
Smokers (n)
1
4
Diabetes type 2 (n)
1
0
Primary fracture treatment (n) No reduction & cast Reduction & cast Reduction & cast + open reduction/bone graft/k-wires/cast External fixator
4 4 1 1
Intra-articular radius fractures (n)
4
Age (yrs; median, 25 and 75 % percentiles)
Intra-articular step (n) <1mm 1.2 mm Time fracture-osteotomy (yrs; median, 25 & 75 % percentiles) Operation length (minutes; median, 25 & 75 % percentiles) Hospitalisation (days; median, 25 & 75 % percentiles)
3 1
2 4 3 1
SC R
Patients (n)
IP T
Norian®
ED
128.0 (118.5; 151,3)
141.0 (128.8; 152.3)
N
U
1.7 (1.1; 2.4)
A
M
A
CC E
PT
Table 1. Patient characteristics
3
1.5 (0.9; 2.5)
3.0 (2.0; 3.0)
Void size (dorsal radial) (8 wks; mm; median; min-max; 25 & 75% percentiles) Void size (volar radial) (8 wks; mm; median; min-max; 25 & 75% percentiles)
3
3.0 (2.0; 4.0)
11.1 (8.3-22.7; 9.5,15.4)
11.8 (7.8-15.6; 9.8,13.8)
6.4 (4.3-16.1; 4.7,9.4)
7.1 (3.0-11.9; 6.0,9.8)
I
Non operated wrist ®
N
Norian Bone graft Norian Bone graft
Operated wrist
8 weeks 10
3 mths 10
6 mths 9
12 mths 9
24 mths 9
10
10
10
10*
10
10
3
5
1
2 0.0 (-0.8;0.0)
2** 0.0 (-1.0;0.3)
0.0 (-0.4;0.5)
1*** 0.0 (-0.8;0.5)
®
0.0 (-1.2;1.7)
3.6 (1.1;5.4)
®
1.2 (0.0;2.5) 11.8 (8.7;13.2)
4.5 (3.5;6.2) 9.0 (6.4;10.2)
0.4 (-0.9;1.3) 13.7 (11.9;14.9)
0.4 (-0.3;1.5) 13.4 (12.8;15.0)
0.9 (-0.3;1.7) 14.4 (12.1;15.3)
0.3 (0.0;1.7) 13.9 (12.7;15.4)
0.7 (-0.2;1.5) 13.8 (12.0;15.1)
11.9 (11.2;13.1)
9.3 (7.9;10.2)
12.8 (10.8;15.0)
12.9 (10.7;14.3)
12.5 (10.4;13.8)
12.8 (10.8;15.0)
12.7 (11.1;14.5)
25.8 (18.9;26.7)
18.8 (11.9;22.7)
28.2 (23.1;31.3)
29.6 (24.6;31.0)
29.9 (24.5;31.6)
29.5 (26.0;31.5)
29.4 (24.0;30.8)
24.7 (21.3;25.9)
19.6 (12.4;23.0)
25.4 (21.3;28.5)
24.7 (21.0;29.0)
23.7 (21.2;28.3)
25.0 (21.1;30.0)
25.5 (21.9;30.0)
12.6 (11.6;14.7)
-18.2 (-21.2;-9.0)
10.4 (5.5;13.9)
10.2 (5.0;12.4)
10.0 (5.4;14.0)
9.5 (6.2;14.5)
9.5 (6.4;14.3)
13.4 (11.9;15.0)
-15.8 (-28.1;-9.6)
9.4 (7.0;13.7)
9.7 (6.6;12.3)
10.9 (7.5;12.7)
10.4 (8.4;13.3)
9.9 (7.5;12.9)
Norian Bone graft
Radial length (mm)
Norian Bone graft ®
ED
Norian Bone graft ®
Volar angulation (degrees )
27
5 0.0 (-1.0;0.3)
Ulna plus (mm)
Radial inclination (degrees)
Operated wrist
Pre-op 10
A
Radiological healing N
®
M
N
N U SC R
Non operated wrist
Norian Bone graft
A
CC E
PT
Table 2. Radiological results (median, 25 and 75 % percentiles) *1 pseudarthrosis reoperated at 6 months,**1 patient where healing was slower in proximal osteotomy than in distal, *** healed at 15 months (pseudarthrosis patient).
I Norian Bone graft
N Pain wrist (VAS)
®
Norian Bone graft Norian Bone graft
Grip strength (kg)
Norian Bone graft ®
Quick-DASH score
Norian Bone graft
Norian Bone graft ®
Norian Bone graft ®
Norian Bone graft
CC E
Radial deviation
®
PT
Extension
Norian Bone graft
Ulnar deviation Pronation
A
Supination
31.0 (25.8;41.0)
ED
Gartland & Werley score
®
30.0 (21.5;38.5)
M
®
®
Norian Bone graft ®
Norian Bone graft ®
Norian Bone graft
Pre-op 10
2 weeks 10
3 mths 10
6 mths 9
12 mths 9
24 mths 9
10 6.0 (5.5;8.0)
10 3.0 (0.8;4.0)
10 3.0 (1.8;4.0)
10 2.5 (2.0;5.3)
10 3.0 (1.0;3.5)
10 2.0 (0.5;3.5)
10 1.0 (0.0;1.5)
5.0 (3.5;8.0)
2.0 (1.8;4.3)
4.0 (0.8;5.3)
3.0 (1.0;5.0)
3.5 (1.5;4.3)
2.5 (1.0;4.0)
0.0 (0.0;1.0)
0.0 (0.0;0.0)
0.0 (0.0;0.0)
0.0 (0.0;0.0)
0.0 (0.0;0.0)
0.0 0.0;0.0)
0.0 (0.0;0.0)
0.0 (0.0;0.0)
0.0 (0.0;0,0)
3.00 (1.5;3.3)a
0.0 (0.0;1.0)
0.0 (0.0;0.3)
0.0 (0.0;0.0)
0.0 (0.0;0.0.)
0.0 (0.0;0.0)
21.0 (14.5;26.5)
11.0 (7.5;14.3)
20.0 (10.5;22.5)
18.0 (16.0;23.0)
21.0 (12.5;29.0)
21.0 (15.3;40.5)
13.0 (7.0;20.5)
20.0 (14.0;35.0)
23.5 (15.8;35.0)
24.0 (18.0;32.5)
44.0 (29.5;51.1)
34.7 (27.1;43.1)
25.0 (12.5;33.6)
27.3 (9.2;38.7)
6.8 (2.3;17.7)
35.0 (21.3;66.5)
43.0 (22.2;55.6)
25.0 (14.2;35.0)
13.2 (6.8;39.8)
0.0 (0.0;6.9)
13.0 (10.8;15.0)
7.5 (5.5;10.0)
6.0 (4.0;6.0)
6.0 (3.5;6.0)
4.0 (2.0;4.5)
14.0 (7.8;16.3)
6.0 (4.0;10.5)
4.0 (3.5;7.0)
4.5 (2.8;6.0)
2.0 (1.0;4.0)
45.0 (35.0;50.0)
30.0 (19.5;42.5)
50.0 (37.0;51.0)
45.0 (40.0;50.0)
40.0 (35.0;58.0)
50.0 (38.8;62.5)
30.0 (20.0;46.3)
50.0 (39.0;65.0)
50.0 (40.0;62.5)
47.5(38.8.;59.5)
65.0 (50.0;75.0)
40.0 (30.0;46.3)
50.0 (45.0;60.0)
60.0 (52.5;63.0)
64.0 (52.0;67.5)
60.0 (47.5;72.5)
42.5 (20.0;50.0)
50.0 (40.0;60.0)
60.0 (52.5;60.5)
60.0 (55.0;65.0)
21.0 (18.8;25.0)
20.0 (10.0;22.8)
20.0 (17.5;26.0)
22.0 (18.0;30.0)
22.0 (20.0;32.0)
30.0 (20.0;30.0)
20.0 (12.0;25.0)
20.0 (20.0;27.5)
24.5 (20.0;30.0)
25.5 (23.5;30.0)
(15.0;31.5)b
22.5 (20.0;26.3)
35.0 (30.0;40.0)
36.0 (32.5;40.0)
40.0 (32.0;40.0)
27.5 (18.8;35.0)c
29.0 (23.8;35.0)
35.0 (30.0;40.0)
35.0 (30.0;40.0)
39.0 (30.5;40.0)
90.0 (78.8;90.0)
90.0 (71.3;90.0)
90.0 (90.0;90.0)
90.0 (90.0;90.0)
90.0 (90.0;90.0)
90.0 (88.8;90.0)
90.0 (80.0;90.0)
90.0 (90.0;90.0)
90.0 (90.0;90.0)
90.0 (90.0;90.0)
60.0 (43.8;90.0)
45.0 (36.3;90.0)
85.0 (55.0;90.0)
90.0 (57.5;90.0)
90.0 (70.0;90.0)
90.0 (83.8;90.0)
80.0 (52.5;86.3)
80.0 (80.0;90.0)
90.0 (83.8;90.0)
90.0 (90.0;90.0)
A
®
Pain hip (VAS)
Flexion
N U SC R
®
N
22.5
Table 3. Functional evaluation (median, 25 and 75 % percentiles) ® Statistically significant findings between Norian and bone graft at 2 weeks a p = 0.011 Statistically significant difference between pre-op and 24 mths b p = 0.011 c p = 0.012
8 weeks 10
28