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Long-term humeral complications after Grammont-style reverse shoulder arthroplasty
ARTICLE IN PRESS J Shoulder Elbow Surg (2017) ■■, ■■–■■
www.elsevier.com/locate/ymse
ORIGINAL ARTICLE
Long-term humeral complications after Grammont-style reverse shoulder arthroplasty Francesco Ascione, MDa,b,*, Peter Domos, MD, FRCSa, Vincenzo Guarrella, MDa, Mikaël Chelli, MDc, Pascal Boileau, MDc, Gilles Walch, MDa a
Centre Orthopédique Santy, Hôpital Privé Jean Mermoz Ramsay GDS, Lyon, France Department of Shoulder Surgery, Campolongo Hospital, Salerno, Italy c Department of Orthopaedic Surgery and Sports Traumatology, Institut Universitaire Locomoteur et du Sport (IULS), Nice, France b
Background: Recent experiences with Grammont reverse shoulder arthroplasty (RSA) have revealed some problems related to the biomechanical changes of the shoulder and humeral stem complications. We analyzed humeral complications in a long-term follow-up of a large series of RSAs, searching for correlations between these and the initial etiology, the follow-up duration, and the clinical outcomes. Materials and methods: Preoperative and postoperative clinical and radiologic assessments of 1035 RSAs with a minimum 5-year follow-up (implanted in 7 specialized shoulder centers between 1993 and 2010) were retrospectively collected. Postoperative humeral complications, managed conservatively or surgically, were radiographically documented. Results: Overall, a 3.3% rate of postoperative humeral complications was found in our database. We identified 17 cases (1.6%) with postoperative humeral fractures, 15 cases (1.4%) with aseptic humeral loosening, and 3 cases (0.3%) with humeral stem disassembly. The humeral complications were more frequent in RSAs implanted for tumors, fracture sequelae, and revision for failed arthroplasty. Discussion: Humeral complications after RSA are not rare, increase with longer follow-up, and have a negative impact on functional outcomes. Postoperative humeral fractures are more frequent in elderly patients, operated on through a superior approach, and after cemented stem implantation. In the absence of associated humeral loosening, conservative treatment should be preferred. Proximal humeral bone loss (due to revisions and tumors) is the most significant risk factor for humeral loosening. Implant unscrewing was initially related to a technological problem, which has been solved, and this complication has disappeared. Level of evidence: Level IV; Case Series; Treatment Study © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. All rights reserved. Keywords: Reverse shoulder arthroplasty; clinical outcomes; complications; humeral stem; fracture; loosening; subsidence; disassembly
The Institutional Review Board of the Ethical Committee of Hôpital Privé Jean Mermoz and Centre Orthopédique Santy read the study project and deemed that it did not infringe on French ethical rules and the privacy of the patients. This committee allowed Francesco Ascione, MD, to perform this study.
*Reprint requests: Francesco Ascione, MD, Via Fiorillo 16, Torre del Greco, NA I-80059, Italy. E-mail address: [email protected] (F. Ascione).
1058-2746/$ - see front matter © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. All rights reserved. https://doi.org/10.1016/j.jse.2017.11.028
ARTICLE IN PRESS 2 Reverse shoulder arthroplasty (RSA) was originally designed to treat pseudoparalysis with cuff tear arthropathy in elderly patients,4,8,24,28 having the dual advantage of tensioning the deltoid muscle to increase its functional strength and decreasing mechanical torque at the glenoid component, thus avoiding glenoid loosening. Because of its success, the indications have expanded to treat massive rotator cuff tears, failed shoulder arthroplasties, acute fractures, fracture sequelae, rheumatoid arthritis, and tumors.22,28 Although RSA is a clinically successful concept, it implies changes in the biomechanics that might increase the potential for complications with longer follow-up. An overall 20% rate of complications has been reported after RSA, though this is related to the initial etiology and the length of follow-up.1,2,8,27,29 Initially, surgeons expected to face glenoid complications and loosening with RSA, but clinical experience has shown that bone adaption, loosening, and complications (bone lysis, implant failures) were more frequent on the humeral side.5,16,20,27 However, information regarding humeral stem complications after RSA (from treatment to final outcome) remains limited to a few small case series. The aim of this study was to analyze the humeral complications that occur after implantation of a Grammont-type RSA in a long-term follow-up of a large series. Our goal was to look for correlations between humeral complications and the initial etiology, the follow-up duration, and the clinical outcomes.
Materials and methods Between 1993 and 2010, 1035 RSAs were performed in 7 orthopedic centers, specializing in shoulder surgery, with a minimum of 5 years’ follow-up. Of the prostheses, 77% were implanted in female patients, with a mean age of 73 years at the time of intervention and involvement of the right shoulder in 67% of cases. Experienced orthopedic surgeons (who were blinded to the clinical assessment and surgery) reviewed the radiographs. All radiologic analyses were performed at last follow-up, which occurred at a mean of 8.2 years (range, 5-20.5 years). The inclusion criteria were RSAs with a minimum 5-year followup. Preoperative, intraoperative, and postoperative data were collected. Preoperative characteristics of the patients, including age, sex, preoperative diagnosis, and previous operations, were evaluated. Intraoperative data included surgical approach, implant characteristics, ability to repair the subscapularis, and adjunctive bone graft procedures. Postoperative data included time to complications and their treatment. Postoperative humeral complications (fracture, loosening and/or migration, disassembly), managed conservatively or surgically, were radiographically documented. The deltopectoral approach was used in 80% of shoulders, and the implant was the Aequalis Reverse (Tornier, Montbonnot Saint Martin, France) in 72% of cases and Delta III (DePuy, Warsaw, IN, USA) in 16%, with a Grammont-style 155° inclination angle in all cases. Cemented stems were implanted in 88% of cases, whereas press-fit stems were used in 12%. All patients underwent preoperative and postoperative rangeof-motion assessment at last follow-up; the Constant-Murley score,13
F. Ascione et al. with the adjusted Constant score,12 and the Subjective Shoulder Value were also recorded. Humeral stem loosening was defined as the presence of complete radiolucent lines in more than 3 zones and/or tilting of the stem, according to previous studies.21,25 Scapular notching was graded according to the classification of Sirveaux et al22 into 5 stages. For statistical analysis, we used the Wilcoxon signed rank test for paired data to compare differences between the last follow-up and the preoperative values, the Kruskal-Wallis test or MannWhitney test for between-group comparisons, and the Fisher test or χ2 test to find relationships between variables. Data were collected and analyzed with the collaborative online software EasyMedStat.com (EasyMedStat, Neuilly-Sur-Seine, France).
Results The overall postoperative complication rate was 18.7% (with the major complications being infection, 4.1%; instability, 3%; neurologic problems, 2.1%; glenoid complications, 2.3%; and scapular fractures, 1.1%) in 1035 shoulders with at least 5-year follow-up. Overall, a 3.3% rate of postoperative humeral complications was found. We identified 17 cases (1.6%) with postoperative humeral fractures, 15 cases (1.4%) with aseptic humeral loosening, and 3 cases (0.3%) with humeral stem disassembly. Humeral complications were more frequent in RSAs implanted for tumors and revision for failed arthroplasty. Complications according to the etiology are detailed in Table I.
Postoperative humeral fractures Postoperative humeral fractures (Fig. 1) occurred more commonly in female patients, at a rate of 94% (vs 77% for nonfracture cases, P = .14) and, consequently, a result of lowenergy trauma. The mean age at operation was the same as that of the full series (75 years), and the dominant side was involved in 65% of cases. Of the 17 humeral fractures, 14 were reported in cases with cemented stems (82% vs 88%, P = .45). The fractures occurred at an average of 55 months after the index operation. The etiology was not found to be a risk factor (Table I).
Treatment Of the patients, 5 (29%) received conservative treatment with a brace for 3 months whereas 12 (71%) were treated surgically. Open reduction–internal fixation with a plate and screws was performed in 10 cases, whereas revision surgery with 1-stage exchange of the humeral stem was performed in 2. No significant difference was found regarding the clinical outcomes according to the treatment (Table II). At last followup, all the fractures united, and the mean Constant score was significantly lower in patients who had a humeral fracture than in those who did not (47 vs 58, P < .001).
ARTICLE IN PRESS Multicenter study of 1035 reverse arthroplasties Table I
3
Complications according to etiology
Total series Etiology Cuff tear arthropathy (Hamada grade 4 or 5) Previous cuff surgery Massive cuff tear (Hamada grade 1, 2, or 3) Primary OA Revision of HA Revision of TSA Revision of RSA Rheumatoid arthritis Tumor Fracture sequelae Acute fracture Other P value
No. of cases
Postoperative humeral fracture, n
Aseptic humeral loosening, n
Humeral disassembly, n
1035
17 (1.6%)
15 (1.4%)
3 (0.3%)
298 180 113 88 72 32 12 36 13 121 37 10
5 (1.7%) 4 (2.2%) 3 (2.7%) 0 (0%) 3 (4.2%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 1 (0.8%) 1 (2.7%) 0 (0%) .75
1 (0.3%) 1 (0.6%) 0 (0%) 0 (0%) 5 (6.9%) 1 (3.1%) 2 (16.7%) 0 (0%) 4 (30.7%) 1 (0.8%) 0 (0%) 0 (0%)
0 (0%) 0 (0%) 0 (0%) 0 (0%) 1 (1.4%) 1 (3.1%) 0 (0%) 0 (0%) 0 (0%) 1 (0.8%) 0 (0%) 0 (0%)
% humeral complications (n) 3.3% (35) 2.0% (6) 2.8% (5) 2.7% (3) 0% (0) 12.5% (9) 6.2% (2) 16.7% (2) 0% (0) 30.7% (4) 2.5% (3) 2.7% (1) 0% (0) < .001
OA, osteoarthritis; HA, hemiarthroplasty; TSA, total shoulder arthroplasty; RSA, reverse shoulder arthroplasty.
Figure 1 Postoperative humeral fracture. (A) Traumatic postoperative humeral fracture 3 years after implantation. (B) Plain radiograph 4 months after sling immobilization. (C) Complete healing 3 years after fracture.
Humeral loosening and migration of stem There were 15 cases (1.4%) of aseptic humeral loosening (Fig. 2). This complication occurred more frequently in younger patients (55 years vs 72 years without loosening, P < .001). The operative approach was deltopectoral in 87% of these cases. The etiology of the initial surgical procedure was revision arthroplasty (8 cases), tumor (4 cases), fracture sequelae (1 case), failed cuff surgery (1 case), or cuff tear arthropathy (1 case). All 15 cases had cemented stems (100% vs 78% without loosening, P = .42). Humeral loosening was not more frequent in patients with scapular notching (46% vs 65%, P = .328) or severe notching of stage 3 or 4 (22% vs 22%, P > .99).
The time delay between the initial operation and the diagnosed stem loosening was 6 years (range, 1.2-15 years). The comparison of outcomes between implants with and without humeral loosening found a lower adjusted Constant score for patients with loose stems (Table III).
Treatment Of these cases, 3 were treated nonoperatively and 12 underwent revision surgery with stem exchange: long cemented stem in 12 cases and custom-made locked stem in 3 patients. Humeral allograft was used in 3 cases. Comparing the results of conservative and surgical treatments showed slightly better outcomes with conservative treatment (Table IV).
ARTICLE IN PRESS 4
F. Ascione et al. Table II Comparison of fracture clinical results according to treatment
AAE, ° AER1, ° AIR1 (out of 10), points Constant score (out of 100) Adjusted Constant score, %
Conservative treatment (5 cases)
ORIF (10 cases)
Long-stem revision (2 cases)
P value
80 6 4
94 8 2.6
100 0 5
NS NS NS
39
50
52
NS
68
75
80
NS
Table III Clinical results of patients with humeral stem loosening versus patients without stem loosening at last follow-up
AAE, ° AER1, ° AIR1 (out of 10), points Constant score (out of 100) Adjusted Constant score, %
Loosening (15 cases)
No loosening (1020 cases)
P value
115 11 4.0
129 13 4.9
NS NS NS
51
58
NS
68
87
NS
AAE, active anterior elevation; AER1, active external rotation with elbow at side; AIR1, active internal rotation hand level; NS, not significant.
AAE, active anterior elevation; AER1, active external rotation with elbow at side; AIR1, active internal rotation hand level; ORIF, open reduction– internal fixation; NS, not significant.
Humeral disassembly Humeral disassembly was observed in 3 shoulders (2 women and 1 man), with a mean age at surgery of 69 years. The right shoulder was involved in all cases; it was also the dominant side (Table I). Humeral disassembly (Fig. 3) occurred either between the diaphyseal and epiphyseal portions of the humeral component (2 cases) or between the epiphyseal part and the additional spacer (1 case). Every patient underwent subsequent revision to address the humeral component. This complication was only observed in cases operated on before 2005 and when the tuberosities were absent (2 revision surgical procedures and 1 case of post-traumatic arthritis).
To overcome this problem, in 2005, a polyethylene washer was added on the threaded part of all the humeral components. This change was successful, as we have not observed any humeral disassembly since 2005. The clinical results are summarized in Table V.
Discussion The Grammont-type RSA implants’ constraints and torsional forces can lead to changes on the humeral side, such as osteolysis, osteopenia, and development of medial and lateral cortical bone narrowing,5,19,20,23,27 due to the medialization of the implant protecting the glenoid from stresses, which are greater on the humerus.4,7,8,14 Cuff et al14 showed a significant increase in rotational micromotion in RSAs with proximal
Figure 2 Humeral loosening. (A) Humeral subsidence of cemented stem 7 years after implantation. (B) Humeral loosening 13 years after implantation (reverse shoulder arthroplasty for post-traumatic arthritis with nonunion of greater tuberosity).
ARTICLE IN PRESS Multicenter study of 1035 reverse arthroplasties
5
Table IV Clinical results according to treatment of humeral stem loosening
SSV, % AAE, ° ER1, ° Constant score Adjusted Constant score, %
Conservative treatment (3 cases)
Stem revision (12 cases)
P value
59 98 18 42.5 62.6
47.5 101 −1 41.3 55
.89 .99 .49 .91 .27
SSV, Subjective Shoulder Value; AAE, active anterior elevation; ER1, external rotation with elbow at side.
Table V Clinical results of patients who underwent revision for humeral disassembly versus those with no humeral disassembly
SSV, % AAE, ° ER1, ° IR1 (0-10), points Constant score Pain ADL Mobility Strength Total Constant score Adjusted Constant score, %
Revision for humeral disassembly
No humeral disassembly
40.8 70 1 2.4
70.3 122 13 4.5
10.1 9.4 13.1 2.7 35.4 49.7
12.2 14.3 23.4 5.4 55 82.6
SSV, Subjective Shoulder Value; AAE, active anterior elevation; ER1, external rotation with elbow at side; IR1, internal rotation hand level; ADL, activities of daily living.
bone loss and a consequent greater failure rate in modular systems, as described by other authors previously.5,7,15,28 This may be one of the modalities that leads to recurrent dislocations, stem loosening, prosthetic dissociation, and humeral component unscrewing and thus to different types of RSA failures. We identified postoperative RSA complications with the humeral stems in 3.3% of all cases. Our results are in agreement with the literature,1,2,7,16,20,27,29 but we had a significantly longer follow-up. Large and recent series have shown the increasing problem of humeral reoperations and complications, reaching a rate of 20% of all RSA complications.1,5,7,19,27 All the humeral problems showed a negative effect on functional outcomes,5-8,19 and they were unsurprisingly more common following complex cases such as revision or tumor surgery in our series.7,19,28,29 Postoperative humeral fractures were more frequent in female patients, patients with cemented stems, and patients who underwent a transdeltoid approach, which might suggest an association with weaker osteoporotic bone and surgical technique. They were generally treated by conservative methods, which did not show significant differences in terms of clinical outcomes in our series (Table II). Some assessments related to the available literature regarding the treatment of postoperative fractures can be confirmed in our series. In transverse or spiral fractures with minimal displacement, splint immobilization may ensure consolidation in 3-6 months.3 In displaced transverse fractures, plate osteosynthesis, with or without autologous bone graft, is mandatory3,9,17; in the case of associated loosening and/or instability, implant revision with a long stem was required.5 Fractures occurred more frequently in revision cases.2,28,29 Patients with humeral fractures demonstrated worse clinical results compared with the outcomes of the other analyzed cases, whichever treatment was adopted (P < .01). Although most humeral fractures after RSA are traumatic (eg, fall) in osteoporotic female patients, uncemented implants seemed to be less exposed to fracture in our series, as opposed
Figure 3 Humeral disassembly. (A) Humeral unscrewing between metallic spacer and epiphyseal part. (B) Humeral unscrewing between epiphyseal and diaphyseal components.
ARTICLE IN PRESS 6 to other series.3,17,18 It can be a consequence of the poor preoperative bone stock, which required a cemented stem. Campbell et al9 suggested that over-reaming of the endosteal diaphysis for cement implantation can lead to periprosthetic fractures with increasing hoop stresses. Other reported risk factors for fractures are related to operative technique (oversized implants, poor surgical exposure, over-rotated arm during stem insertion),9,11,15 which we did not observe in our series. Humeral stem loosening as well as migration (1.4%) not only contributes to shoulder dysfunction but also may be a major contributor to the failure of the prosthesis. It involved younger and male patients probably because of higher strain and demand on the prosthesis, exclusively affected cemented stems, and negatively influenced the clinical results, as other studies have reported.10,26 The rate of humeral loosening, migration, and/or subsidence rises to 1.7% in cemented stems, whereas no cases occurred in press-fit implants (12% of arthroplasties). Although both complications mentioned negatively influenced the overall clinical results, the best treatment option is still conservative treatment in our series, if appropriate. Conservative treatment was proposed for shoulders that did not manifest a significant worsening of functional scores, severe radiographic loosening and/or migration, or proximal bone loss; this is one of the reasons immobilization provides better outcomes (3 of 15 RSAs). Otherwise, stem revision (12 cases) was a viable option to adopt with the aim of enhancing implant stability. Regarding humeral proximal defects exceeding 5 cm, an additional massive humeral allograft was used in 3 cases.5,10 Alentorn-Geli et al,2 in their review of more than 3000 surgical procedures, showed that humeral loosening can occur at a rate as high as 4% and is less common with the deltopectoral approach. Our results confirm what has been reported earlier: Proximal humeral bone loss is the main risk factor for humeral loosening.3,5-7,15,19,20 It is more frequent after RSA implantation for fracture or for fracture sequelae (because of tuberosity migration and resorption) and after tumor (because of proximal humeral resection), as well as revision surgery. In our series, revision, tumor, and fracture sequelae covered 87% of loose stem etiologies. In the absence of the greater tuberosity, the humeral component is fixed only distally and undergoes considerable rotational stress, leading to loosening and disassembly in modular implants.5,14 These mechanical factors may often be aggravated by osteoporosis and osteolysis, which are especially frequent in the case of impingement between the humeral socket and scapular pillar, causing consequent scapular notching, secondary osteolysis of the humeral bone, and instability.5,7,16,27,29 Conversely to our hypothesis, humeral loosening and/or migration and scapular notching occurrence and severity were not significantly correlated. Our series also showed that the risk of humeral aseptic loosening increases with a longer follow-up.5 Similar to the study of Chuinard et al,11 our study found humeral disassembly to be a minor problem subsequent to the design changes to the Delta III prosthesis, and fortunately, this complication was completely eliminated following
F. Ascione et al. the modification of the prosthesis design in 2005. Revision for humeral disassembly also poorly affected the outcomes.15 The major weakness of our study is its retrospective and multicenter nature, with the inherent flaws of the study design. The surgical indication and technique, as well as postoperative management, may vary between surgeons and centers. The major strengths of this study are that a large number of RSAs were included in the database and the assessment was performed blindly according to the same standardized protocol. Another positive aspect is the long follow-up to assess humeral complications after RSA. To our knowledge, there are only a few studies in the literature that have focused on humeral RSA problems in the long term.
Conclusions Humeral complications after RSA are not rare (3.3%) and have a negative impact on functional outcomes. They are more common following difficult cases such as revision for failed arthroplasty or tumor surgery. Postoperative humeral fractures (1.6%) are more frequent in elderly patients, operated on through a superior approach, and after cemented stem implantation. In the absence of associated humeral loosening, conservative treatment should be preferred. Humeral loosening (1.4%) is more frequent in cases of fracture or of fracture sequelae (because of tuberosity migration or resorption), as well as in tumors (because of proximal humeral resection). Proximal humeral bone loss remains the most frequent reason for humeral loosening (revisions and tumors). Proximal humeral reconstruction (with allograft or massive prosthesis) is of paramount importance to counteract rotational shearing forces and recurrent loosening. Implant unscrewing was related to a technological problem, which was solved in 2005, and this complication has disappeared.
Disclaimer Pascal Boileau receives royalties and fees for consulting from Wright-Tornier and FH Orthopedics and fees for consulting from Arthrex and ConMed. Gilles Walch receives royalties from Wright-Tornier and equity from Imascap. The other authors, their immediate families, and any research foundations with which they are affiliated have not received any financial payments or other benefits from any commercial entity related to the subject of this article.
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ORIGINAL ARTICLE
Long-term humeral complications after Grammont-style reverse shoulder arthroplasty Francesco Ascione, MDa,b,*, Peter Domos, MD, FRCSa, Vincenzo Guarrella, MDa, Mikaël Chelli, MDc, Pascal Boileau, MDc, Gilles Walch, MDa a
Centre Orthopédique Santy, Hôpital Privé Jean Mermoz Ramsay GDS, Lyon, France Department of Shoulder Surgery, Campolongo Hospital, Salerno, Italy c Department of Orthopaedic Surgery and Sports Traumatology, Institut Universitaire Locomoteur et du Sport (IULS), Nice, France b
Background: Recent experiences with Grammont reverse shoulder arthroplasty (RSA) have revealed some problems related to the biomechanical changes of the shoulder and humeral stem complications. We analyzed humeral complications in a long-term follow-up of a large series of RSAs, searching for correlations between these and the initial etiology, the follow-up duration, and the clinical outcomes. Materials and methods: Preoperative and postoperative clinical and radiologic assessments of 1035 RSAs with a minimum 5-year follow-up (implanted in 7 specialized shoulder centers between 1993 and 2010) were retrospectively collected. Postoperative humeral complications, managed conservatively or surgically, were radiographically documented. Results: Overall, a 3.3% rate of postoperative humeral complications was found in our database. We identified 17 cases (1.6%) with postoperative humeral fractures, 15 cases (1.4%) with aseptic humeral loosening, and 3 cases (0.3%) with humeral stem disassembly. The humeral complications were more frequent in RSAs implanted for tumors, fracture sequelae, and revision for failed arthroplasty. Discussion: Humeral complications after RSA are not rare, increase with longer follow-up, and have a negative impact on functional outcomes. Postoperative humeral fractures are more frequent in elderly patients, operated on through a superior approach, and after cemented stem implantation. In the absence of associated humeral loosening, conservative treatment should be preferred. Proximal humeral bone loss (due to revisions and tumors) is the most significant risk factor for humeral loosening. Implant unscrewing was initially related to a technological problem, which has been solved, and this complication has disappeared. Level of evidence: Level IV; Case Series; Treatment Study © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. All rights reserved. Keywords: Reverse shoulder arthroplasty; clinical outcomes; complications; humeral stem; fracture; loosening; subsidence; disassembly
The Institutional Review Board of the Ethical Committee of Hôpital Privé Jean Mermoz and Centre Orthopédique Santy read the study project and deemed that it did not infringe on French ethical rules and the privacy of the patients. This committee allowed Francesco Ascione, MD, to perform this study.
*Reprint requests: Francesco Ascione, MD, Via Fiorillo 16, Torre del Greco, NA I-80059, Italy. E-mail address: [email protected] (F. Ascione).
1058-2746/$ - see front matter © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. All rights reserved. https://doi.org/10.1016/j.jse.2017.11.028
ARTICLE IN PRESS 2 Reverse shoulder arthroplasty (RSA) was originally designed to treat pseudoparalysis with cuff tear arthropathy in elderly patients,4,8,24,28 having the dual advantage of tensioning the deltoid muscle to increase its functional strength and decreasing mechanical torque at the glenoid component, thus avoiding glenoid loosening. Because of its success, the indications have expanded to treat massive rotator cuff tears, failed shoulder arthroplasties, acute fractures, fracture sequelae, rheumatoid arthritis, and tumors.22,28 Although RSA is a clinically successful concept, it implies changes in the biomechanics that might increase the potential for complications with longer follow-up. An overall 20% rate of complications has been reported after RSA, though this is related to the initial etiology and the length of follow-up.1,2,8,27,29 Initially, surgeons expected to face glenoid complications and loosening with RSA, but clinical experience has shown that bone adaption, loosening, and complications (bone lysis, implant failures) were more frequent on the humeral side.5,16,20,27 However, information regarding humeral stem complications after RSA (from treatment to final outcome) remains limited to a few small case series. The aim of this study was to analyze the humeral complications that occur after implantation of a Grammont-type RSA in a long-term follow-up of a large series. Our goal was to look for correlations between humeral complications and the initial etiology, the follow-up duration, and the clinical outcomes.
Materials and methods Between 1993 and 2010, 1035 RSAs were performed in 7 orthopedic centers, specializing in shoulder surgery, with a minimum of 5 years’ follow-up. Of the prostheses, 77% were implanted in female patients, with a mean age of 73 years at the time of intervention and involvement of the right shoulder in 67% of cases. Experienced orthopedic surgeons (who were blinded to the clinical assessment and surgery) reviewed the radiographs. All radiologic analyses were performed at last follow-up, which occurred at a mean of 8.2 years (range, 5-20.5 years). The inclusion criteria were RSAs with a minimum 5-year followup. Preoperative, intraoperative, and postoperative data were collected. Preoperative characteristics of the patients, including age, sex, preoperative diagnosis, and previous operations, were evaluated. Intraoperative data included surgical approach, implant characteristics, ability to repair the subscapularis, and adjunctive bone graft procedures. Postoperative data included time to complications and their treatment. Postoperative humeral complications (fracture, loosening and/or migration, disassembly), managed conservatively or surgically, were radiographically documented. The deltopectoral approach was used in 80% of shoulders, and the implant was the Aequalis Reverse (Tornier, Montbonnot Saint Martin, France) in 72% of cases and Delta III (DePuy, Warsaw, IN, USA) in 16%, with a Grammont-style 155° inclination angle in all cases. Cemented stems were implanted in 88% of cases, whereas press-fit stems were used in 12%. All patients underwent preoperative and postoperative rangeof-motion assessment at last follow-up; the Constant-Murley score,13
F. Ascione et al. with the adjusted Constant score,12 and the Subjective Shoulder Value were also recorded. Humeral stem loosening was defined as the presence of complete radiolucent lines in more than 3 zones and/or tilting of the stem, according to previous studies.21,25 Scapular notching was graded according to the classification of Sirveaux et al22 into 5 stages. For statistical analysis, we used the Wilcoxon signed rank test for paired data to compare differences between the last follow-up and the preoperative values, the Kruskal-Wallis test or MannWhitney test for between-group comparisons, and the Fisher test or χ2 test to find relationships between variables. Data were collected and analyzed with the collaborative online software EasyMedStat.com (EasyMedStat, Neuilly-Sur-Seine, France).
Results The overall postoperative complication rate was 18.7% (with the major complications being infection, 4.1%; instability, 3%; neurologic problems, 2.1%; glenoid complications, 2.3%; and scapular fractures, 1.1%) in 1035 shoulders with at least 5-year follow-up. Overall, a 3.3% rate of postoperative humeral complications was found. We identified 17 cases (1.6%) with postoperative humeral fractures, 15 cases (1.4%) with aseptic humeral loosening, and 3 cases (0.3%) with humeral stem disassembly. Humeral complications were more frequent in RSAs implanted for tumors and revision for failed arthroplasty. Complications according to the etiology are detailed in Table I.
Postoperative humeral fractures Postoperative humeral fractures (Fig. 1) occurred more commonly in female patients, at a rate of 94% (vs 77% for nonfracture cases, P = .14) and, consequently, a result of lowenergy trauma. The mean age at operation was the same as that of the full series (75 years), and the dominant side was involved in 65% of cases. Of the 17 humeral fractures, 14 were reported in cases with cemented stems (82% vs 88%, P = .45). The fractures occurred at an average of 55 months after the index operation. The etiology was not found to be a risk factor (Table I).
Treatment Of the patients, 5 (29%) received conservative treatment with a brace for 3 months whereas 12 (71%) were treated surgically. Open reduction–internal fixation with a plate and screws was performed in 10 cases, whereas revision surgery with 1-stage exchange of the humeral stem was performed in 2. No significant difference was found regarding the clinical outcomes according to the treatment (Table II). At last followup, all the fractures united, and the mean Constant score was significantly lower in patients who had a humeral fracture than in those who did not (47 vs 58, P < .001).
ARTICLE IN PRESS Multicenter study of 1035 reverse arthroplasties Table I
3
Complications according to etiology
Total series Etiology Cuff tear arthropathy (Hamada grade 4 or 5) Previous cuff surgery Massive cuff tear (Hamada grade 1, 2, or 3) Primary OA Revision of HA Revision of TSA Revision of RSA Rheumatoid arthritis Tumor Fracture sequelae Acute fracture Other P value
No. of cases
Postoperative humeral fracture, n
Aseptic humeral loosening, n
Humeral disassembly, n
1035
17 (1.6%)
15 (1.4%)
3 (0.3%)
298 180 113 88 72 32 12 36 13 121 37 10
5 (1.7%) 4 (2.2%) 3 (2.7%) 0 (0%) 3 (4.2%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 1 (0.8%) 1 (2.7%) 0 (0%) .75
1 (0.3%) 1 (0.6%) 0 (0%) 0 (0%) 5 (6.9%) 1 (3.1%) 2 (16.7%) 0 (0%) 4 (30.7%) 1 (0.8%) 0 (0%) 0 (0%)
0 (0%) 0 (0%) 0 (0%) 0 (0%) 1 (1.4%) 1 (3.1%) 0 (0%) 0 (0%) 0 (0%) 1 (0.8%) 0 (0%) 0 (0%)
% humeral complications (n) 3.3% (35) 2.0% (6) 2.8% (5) 2.7% (3) 0% (0) 12.5% (9) 6.2% (2) 16.7% (2) 0% (0) 30.7% (4) 2.5% (3) 2.7% (1) 0% (0) < .001
OA, osteoarthritis; HA, hemiarthroplasty; TSA, total shoulder arthroplasty; RSA, reverse shoulder arthroplasty.
Figure 1 Postoperative humeral fracture. (A) Traumatic postoperative humeral fracture 3 years after implantation. (B) Plain radiograph 4 months after sling immobilization. (C) Complete healing 3 years after fracture.
Humeral loosening and migration of stem There were 15 cases (1.4%) of aseptic humeral loosening (Fig. 2). This complication occurred more frequently in younger patients (55 years vs 72 years without loosening, P < .001). The operative approach was deltopectoral in 87% of these cases. The etiology of the initial surgical procedure was revision arthroplasty (8 cases), tumor (4 cases), fracture sequelae (1 case), failed cuff surgery (1 case), or cuff tear arthropathy (1 case). All 15 cases had cemented stems (100% vs 78% without loosening, P = .42). Humeral loosening was not more frequent in patients with scapular notching (46% vs 65%, P = .328) or severe notching of stage 3 or 4 (22% vs 22%, P > .99).
The time delay between the initial operation and the diagnosed stem loosening was 6 years (range, 1.2-15 years). The comparison of outcomes between implants with and without humeral loosening found a lower adjusted Constant score for patients with loose stems (Table III).
Treatment Of these cases, 3 were treated nonoperatively and 12 underwent revision surgery with stem exchange: long cemented stem in 12 cases and custom-made locked stem in 3 patients. Humeral allograft was used in 3 cases. Comparing the results of conservative and surgical treatments showed slightly better outcomes with conservative treatment (Table IV).
ARTICLE IN PRESS 4
F. Ascione et al. Table II Comparison of fracture clinical results according to treatment
AAE, ° AER1, ° AIR1 (out of 10), points Constant score (out of 100) Adjusted Constant score, %
Conservative treatment (5 cases)
ORIF (10 cases)
Long-stem revision (2 cases)
P value
80 6 4
94 8 2.6
100 0 5
NS NS NS
39
50
52
NS
68
75
80
NS
Table III Clinical results of patients with humeral stem loosening versus patients without stem loosening at last follow-up
AAE, ° AER1, ° AIR1 (out of 10), points Constant score (out of 100) Adjusted Constant score, %
Loosening (15 cases)
No loosening (1020 cases)
P value
115 11 4.0
129 13 4.9
NS NS NS
51
58
NS
68
87
NS
AAE, active anterior elevation; AER1, active external rotation with elbow at side; AIR1, active internal rotation hand level; NS, not significant.
AAE, active anterior elevation; AER1, active external rotation with elbow at side; AIR1, active internal rotation hand level; ORIF, open reduction– internal fixation; NS, not significant.
Humeral disassembly Humeral disassembly was observed in 3 shoulders (2 women and 1 man), with a mean age at surgery of 69 years. The right shoulder was involved in all cases; it was also the dominant side (Table I). Humeral disassembly (Fig. 3) occurred either between the diaphyseal and epiphyseal portions of the humeral component (2 cases) or between the epiphyseal part and the additional spacer (1 case). Every patient underwent subsequent revision to address the humeral component. This complication was only observed in cases operated on before 2005 and when the tuberosities were absent (2 revision surgical procedures and 1 case of post-traumatic arthritis).
To overcome this problem, in 2005, a polyethylene washer was added on the threaded part of all the humeral components. This change was successful, as we have not observed any humeral disassembly since 2005. The clinical results are summarized in Table V.
Discussion The Grammont-type RSA implants’ constraints and torsional forces can lead to changes on the humeral side, such as osteolysis, osteopenia, and development of medial and lateral cortical bone narrowing,5,19,20,23,27 due to the medialization of the implant protecting the glenoid from stresses, which are greater on the humerus.4,7,8,14 Cuff et al14 showed a significant increase in rotational micromotion in RSAs with proximal
Figure 2 Humeral loosening. (A) Humeral subsidence of cemented stem 7 years after implantation. (B) Humeral loosening 13 years after implantation (reverse shoulder arthroplasty for post-traumatic arthritis with nonunion of greater tuberosity).
ARTICLE IN PRESS Multicenter study of 1035 reverse arthroplasties
5
Table IV Clinical results according to treatment of humeral stem loosening
SSV, % AAE, ° ER1, ° Constant score Adjusted Constant score, %
Conservative treatment (3 cases)
Stem revision (12 cases)
P value
59 98 18 42.5 62.6
47.5 101 −1 41.3 55
.89 .99 .49 .91 .27
SSV, Subjective Shoulder Value; AAE, active anterior elevation; ER1, external rotation with elbow at side.
Table V Clinical results of patients who underwent revision for humeral disassembly versus those with no humeral disassembly
SSV, % AAE, ° ER1, ° IR1 (0-10), points Constant score Pain ADL Mobility Strength Total Constant score Adjusted Constant score, %
Revision for humeral disassembly
No humeral disassembly
40.8 70 1 2.4
70.3 122 13 4.5
10.1 9.4 13.1 2.7 35.4 49.7
12.2 14.3 23.4 5.4 55 82.6
SSV, Subjective Shoulder Value; AAE, active anterior elevation; ER1, external rotation with elbow at side; IR1, internal rotation hand level; ADL, activities of daily living.
bone loss and a consequent greater failure rate in modular systems, as described by other authors previously.5,7,15,28 This may be one of the modalities that leads to recurrent dislocations, stem loosening, prosthetic dissociation, and humeral component unscrewing and thus to different types of RSA failures. We identified postoperative RSA complications with the humeral stems in 3.3% of all cases. Our results are in agreement with the literature,1,2,7,16,20,27,29 but we had a significantly longer follow-up. Large and recent series have shown the increasing problem of humeral reoperations and complications, reaching a rate of 20% of all RSA complications.1,5,7,19,27 All the humeral problems showed a negative effect on functional outcomes,5-8,19 and they were unsurprisingly more common following complex cases such as revision or tumor surgery in our series.7,19,28,29 Postoperative humeral fractures were more frequent in female patients, patients with cemented stems, and patients who underwent a transdeltoid approach, which might suggest an association with weaker osteoporotic bone and surgical technique. They were generally treated by conservative methods, which did not show significant differences in terms of clinical outcomes in our series (Table II). Some assessments related to the available literature regarding the treatment of postoperative fractures can be confirmed in our series. In transverse or spiral fractures with minimal displacement, splint immobilization may ensure consolidation in 3-6 months.3 In displaced transverse fractures, plate osteosynthesis, with or without autologous bone graft, is mandatory3,9,17; in the case of associated loosening and/or instability, implant revision with a long stem was required.5 Fractures occurred more frequently in revision cases.2,28,29 Patients with humeral fractures demonstrated worse clinical results compared with the outcomes of the other analyzed cases, whichever treatment was adopted (P < .01). Although most humeral fractures after RSA are traumatic (eg, fall) in osteoporotic female patients, uncemented implants seemed to be less exposed to fracture in our series, as opposed
Figure 3 Humeral disassembly. (A) Humeral unscrewing between metallic spacer and epiphyseal part. (B) Humeral unscrewing between epiphyseal and diaphyseal components.
ARTICLE IN PRESS 6 to other series.3,17,18 It can be a consequence of the poor preoperative bone stock, which required a cemented stem. Campbell et al9 suggested that over-reaming of the endosteal diaphysis for cement implantation can lead to periprosthetic fractures with increasing hoop stresses. Other reported risk factors for fractures are related to operative technique (oversized implants, poor surgical exposure, over-rotated arm during stem insertion),9,11,15 which we did not observe in our series. Humeral stem loosening as well as migration (1.4%) not only contributes to shoulder dysfunction but also may be a major contributor to the failure of the prosthesis. It involved younger and male patients probably because of higher strain and demand on the prosthesis, exclusively affected cemented stems, and negatively influenced the clinical results, as other studies have reported.10,26 The rate of humeral loosening, migration, and/or subsidence rises to 1.7% in cemented stems, whereas no cases occurred in press-fit implants (12% of arthroplasties). Although both complications mentioned negatively influenced the overall clinical results, the best treatment option is still conservative treatment in our series, if appropriate. Conservative treatment was proposed for shoulders that did not manifest a significant worsening of functional scores, severe radiographic loosening and/or migration, or proximal bone loss; this is one of the reasons immobilization provides better outcomes (3 of 15 RSAs). Otherwise, stem revision (12 cases) was a viable option to adopt with the aim of enhancing implant stability. Regarding humeral proximal defects exceeding 5 cm, an additional massive humeral allograft was used in 3 cases.5,10 Alentorn-Geli et al,2 in their review of more than 3000 surgical procedures, showed that humeral loosening can occur at a rate as high as 4% and is less common with the deltopectoral approach. Our results confirm what has been reported earlier: Proximal humeral bone loss is the main risk factor for humeral loosening.3,5-7,15,19,20 It is more frequent after RSA implantation for fracture or for fracture sequelae (because of tuberosity migration and resorption) and after tumor (because of proximal humeral resection), as well as revision surgery. In our series, revision, tumor, and fracture sequelae covered 87% of loose stem etiologies. In the absence of the greater tuberosity, the humeral component is fixed only distally and undergoes considerable rotational stress, leading to loosening and disassembly in modular implants.5,14 These mechanical factors may often be aggravated by osteoporosis and osteolysis, which are especially frequent in the case of impingement between the humeral socket and scapular pillar, causing consequent scapular notching, secondary osteolysis of the humeral bone, and instability.5,7,16,27,29 Conversely to our hypothesis, humeral loosening and/or migration and scapular notching occurrence and severity were not significantly correlated. Our series also showed that the risk of humeral aseptic loosening increases with a longer follow-up.5 Similar to the study of Chuinard et al,11 our study found humeral disassembly to be a minor problem subsequent to the design changes to the Delta III prosthesis, and fortunately, this complication was completely eliminated following
F. Ascione et al. the modification of the prosthesis design in 2005. Revision for humeral disassembly also poorly affected the outcomes.15 The major weakness of our study is its retrospective and multicenter nature, with the inherent flaws of the study design. The surgical indication and technique, as well as postoperative management, may vary between surgeons and centers. The major strengths of this study are that a large number of RSAs were included in the database and the assessment was performed blindly according to the same standardized protocol. Another positive aspect is the long follow-up to assess humeral complications after RSA. To our knowledge, there are only a few studies in the literature that have focused on humeral RSA problems in the long term.
Conclusions Humeral complications after RSA are not rare (3.3%) and have a negative impact on functional outcomes. They are more common following difficult cases such as revision for failed arthroplasty or tumor surgery. Postoperative humeral fractures (1.6%) are more frequent in elderly patients, operated on through a superior approach, and after cemented stem implantation. In the absence of associated humeral loosening, conservative treatment should be preferred. Humeral loosening (1.4%) is more frequent in cases of fracture or of fracture sequelae (because of tuberosity migration or resorption), as well as in tumors (because of proximal humeral resection). Proximal humeral bone loss remains the most frequent reason for humeral loosening (revisions and tumors). Proximal humeral reconstruction (with allograft or massive prosthesis) is of paramount importance to counteract rotational shearing forces and recurrent loosening. Implant unscrewing was related to a technological problem, which was solved in 2005, and this complication has disappeared.
Disclaimer Pascal Boileau receives royalties and fees for consulting from Wright-Tornier and FH Orthopedics and fees for consulting from Arthrex and ConMed. Gilles Walch receives royalties from Wright-Tornier and equity from Imascap. The other authors, their immediate families, and any research foundations with which they are affiliated have not received any financial payments or other benefits from any commercial entity related to the subject of this article.
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