Abstract
Aims
The aims of this study were to validate the outcome of total elbow arthroplasty (TEA) in patients with rheumatoid arthritis (RA), and to identify factors that affect the outcome.
Methods
We searched PubMed, MEDLINE, Cochrane Reviews, and Embase from between January 2003 and March 2019. The primary aim was to determine the implant failure rate, the mode of failure, and risk factors predisposing to failure. A secondary aim was to identify the overall complication rate, associated risk factors, and clinical performance. A meta-regression analysis was completed to identify the association between each parameter with the outcome.
Results
A total of 38 studies including 2,118 TEAs were included in the study. The mean follow-up was 80.9 months (8.2 to 156). The implant failure and complication rates were 16.1% (95% confidence interval (CI) 0.128 to 0.200) and 24.5% (95% CI 0.203 to 0.293), respectively. Aseptic loosening was the most common mode of failure (9.5%; 95% CI 0.071 to 0.124). The mean postoperative ranges of motion (ROMs) were: flexion 131.5° (124.2° to 138.8°), extension 29.3° (26.8° to 31.9°), pronation 74.0° (67.8° to 80.2°), and supination 72.5° (69.5° to 75.5°), and the mean postoperative Mayo Elbow Performance Score (MEPS) was 89.3 (95% CI 86.9 to 91.6). The meta-regression analysis identified that younger patients and implants with an unlinked design correlated with higher failure rates. Younger patients were associated with increased complications, while female patients and an unlinked prosthesis were associated with aseptic loosening.
Conclusion
TEA continues to provide satisfactory results for patients with RA. However, it is associated with a substantially higher implant failure and complication rates compared with hip and knee arthroplasties. The patient’s age, sex, and whether cemented fixation and unlinked prosthesis were used can influence the outcome.
Level of Evidence: Therapeutic Level IV.
Cite this article: Bone Joint J 2020;102-B(8):967–980.
Take home message
Total elbow arthroplasty (TEA) provides satisfactory results in patients with rheumatoid arthritis (RA) but is associated with higher implant failure and complication rates compared with hip and knee arthroplasties.
The patient’s age, sex, cemented fixation, and prosthesis with unlinked designs may influence the outcome.
Younger patients were associated with increased complications, while female patients and an unlinked prosthesis were associated with aseptic loosening.
Introduction
Rheumatoid arthritis (RA) is the most common form of chronic inflammatory arthritis and affects about 1% of adults.1 It is characterized by progressive, symmetrical arthritis involving many joints, most commonly the knee, wrist and interphalangeal joints.2 The elbow is affected in between 20% and 65% of patients, often causing severe painful disability.1 In patients with severe arthritis, many forms of treatment are available to relieve pain and improve function.3,4 Total elbow arthroplasty (TEA) is commonly performed for end-stage arthritis.4 However, TEA has inferior implant survival and higher complication rates compared with arthroplasties of other major joints.6 This is usually thought to be due to the high risks associated with RA and the complex anatomy of the elbow joint.7 Major improvements in the design and materials of TEA have been made in attempts at address these issues.6 There are currently two major designs of TEA: a linked and an unlinked (semi-constrained and non-constrained) prosthesis. The unlinked design resembles the native elbow but requires intact surrounding ligamentous and soft tissue stabilizers to avoid devastating complications such as recurrent dislocation.8 On the other hand, the linked prosthesis allows for ligamentous deficiency, but has high rates of polyethylene (PE) wear secondary to the inherent stability.9 A cemented technique was introduced in an attempt to reduce the incidence of loosening.10 Most studies in the literature have focused on a single design, with only a few studies comparing different implants. Welsink et al4 described the outcome of different TEA designs with emphasis on implant survival. However, the patients included those with many different aetiologies, including post-traumatic arthritis, osteoarthritis (OA), and RA. The risk factors associated with implant failure were also not discussed. Little et al11 reported the results of TEA for studies completed before 2003. With recent advancements in the design of components and perioperative care, we aimed to provide an update on the overall outcome of TEA. Our main aim was to review the implant failure rate, complication rate, and functional performance of TEA in patients with RA, and to identify factors that affect the outcome.
Methods
A comprehensive search was completed on PubMed, MEDLINE, Cochrane Reviews, and Embase for studies evaluating TEA in patients with RA published between January 2003 and March 2019. The search was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. The following terms were used in variable combination: total elbow arthroplasty, total elbow replacement and rheumatoid arthritis. Two authors (TFC, SWT) independently conducted the searches and screened the titles and abstracts to identify relevant studies. The strategy is shown in Figure 1. If there was disagreement, a third author (HHM) was consulted and a consensus was obtained.
Fig. 1
We identified original studies in English that presented data on patients with RA who had undergone TEA. We excluded studies before 2003, patients with other aetiologies, review articles, letters to the editor, expert opinion, and studies in which data were not obtainable. For studies in which different groups were compared (e.g. linked vs unlinked prosthesis), we analyzed each group separately if possible. If there was uncertainty regarding a study, we contacted the authors to clarify our concerns. If there was disagreement between the authors, a third author was consulted.
Two authors (TFC, SWT) examined all the identified studies and extracted data using a predetermined form. The primary aim was to determine the overall implant failure rate, failure mode, and risk factors predisposing to failure. A secondary aim was to validate the complication rate, identify associated risk factors, and assess the clinical performance. In this meta-analysis we recorded the first author, year of publication, study design, number of cases, age, length of follow-up, the type and design of the implant, the use of cement, and outcome parameters as shown in Table I. In order to determine the modes of failure, we recorded the rate of aseptic loosening, septic loosening, instability, bushing wear, axle failure, and implant fractures. We also recorded all complications, such as ulnar neuropathy, triceps injury, and infection, that are pertinent to TEA. A perioperative infection was defined based on the severity of the infection. A deep infection required a surgical procedure such as irrigation and debridement with retention of the implant. Aseptic loosening was defined as the most severe type of infection with radiological evidence of loosening which required extensive debridement and removal of the implant. The clinical performance was assessed based on the range of motion (ROM) (flexion, extension, arc of motion, supination, and pronation) and Mayo Elbow Performance Score (MEPS).12
Table I.
Author, year | Study design | Number of TEA surgery | Mean age, yrs | Follow-up duration, mths | Implant type | Design | Cemented/ hybrid/ cementless |
Outcome measurements | |||
---|---|---|---|---|---|---|---|---|---|---|---|
A* | B† | C‡ | D§ | ||||||||
Lo et al,13 2003 | Case series | 17 | 58 | 36 | Coonrad-Morrey¶ | Linked | Cemented | V | V | V | V |
Potter et al,14 2003 | Case series | 2 | 60 | 74 | Kudo type 5** | Unlinked | Cemented | V | V | N/A | N/A |
Reinhard et al,15 2003 | Case series | 44 | 53 | 92.4 | Kudo type 4†† | Unlinked | Cementless | V | V | N/A | N/A |
Samijo et al,16 2003 | Case series | 35 | 63 | 98.4 | Souter-Strathclyde‡‡ | Unlinked | Cemented | V | V | V | N/A |
Van der Lugt et al,17 2004 | Case series | 204 | 61 | 76.8 | Souter-Strathclyde‡‡ | Unlinked | Cemented | V | V | V | N/A |
Willems and De Smet,18 2004 | Case series | 24 | 57.5 | 58 | Kudo type 4†† and 5** | Unlinked | Cemented | V | V | V | V |
Khatri and Stirrat,19 2005 | Case series | 47 | 59 | 82 | Souter-Strathclyde‡‡ | Unlinked | Cemented | V | V | N/A | N/A |
Lee,20 2005 | Case series | 8 | 55.5 | 39.4 | Coonrad-Morrey¶ | Linked | Cemented | V | V | V | V |
Little,21 2005 | Cohort study | 33 | 63 | 61 | Souter-Strathclyde‡‡ | Unlinked | Cemented | V | V | V | N/A |
33 | 60 | 67 | Kudo type 5** | Unlinked | Cemented | V | N/A | V | N/A | ||
33 | 65 | 68 | Coonrad-Morrey¶ | Linked | Cemented | V | N/A | V | N/A | ||
Ovesen et al,22 2005 | Case series | 43 | 56 | 82.8 | Capitello-Condylar§§ | Unlinked | Cemented | V | V | V | V |
Jensen et al,23 2006 | Case series | 20 | 64 | 60 | GSB III prosthesis¶¶ | Linked | Cemented | V | V | V | N/A |
Landor et al,24 2006 | Case series | 45 | 53 | 114 | Souter-Strathclyde‡‡ | Unlinked | Cemented | V | V | V | N/A |
Mori et al,25 2006 | Case series | 14 | 53.3 | 91 | Kudo type 5** | Unlinked | 2 cemented, 10 hybrid, 2 cementless | V | V | V | V |
Rauhaniemi et al,26 2006 | Case series | 28 | 58 | 58 | Kudo type 5** | Unlinked | 3 cemented, 25 hybrid | V | V | N/A | N/A |
Thillemann et al,27 2006 | Case series | 17 | 60 | 114 | Kudo type 3*** | Unlinked | Cemented | V | V | V | V |
Brinkman et al,28 2007 | Case series | 49 | 56 | 72 | Kudo type 5** | Unlinked | Cementless | V | V | V | N/A |
Cesar et al,29 2007 | Case series | 44 | 56 | 74 | GSB III prosthesis¶¶ | Linked | Cemented | V | V | V | N/A |
Skyttä et al,30 2008 | Cohort study | 21 | 59 | 129.6 | Souter-Strathclyde‡‡ | Unlinked | Cemented | V | V | V | N/A |
Cohort study | 21 | 62 | 81.6 | Kudo type 5** | Unlinked | Cemented | V | V | V | N/A | |
Tachihara et al,31 2008 | Cohort study | 34 | 60 | 55.7 | JACE††† | Unlinked | 16 cemented, 18 cementless | V | V | V | N/A |
Cohort study | 13 | 61 | 59.5 | STABLE prosthesis‡‡‡ | Unlinked | 11 cemented, 2 cementless | V | V | V | N/A | |
Cohort study | 32 | 63 | 28.2 | Kudo type 5** | Unlinked | 17 cemented, 15 cementless | V | V | V | N/A | |
Amirfeyz and Blewitt,32 2009 | Cohort study | 31 | 67 | 53 | GSB III prosthesis¶¶ | Linked | Cemented | V | V | V | V |
Kleinlugtenbelt et al,33 2010 | Case series | 20 | 62 | 49 | iBP‡‡‡ | Unlinked | Hybrid | V | V | V | V |
Prasad and Dent,34 2010 | Cohort study | 44 | 60 | 108 | Souter-Strathclyde‡‡ | Unlinked | Cemented | V | V | N/A | N/A |
Cohort study | 55 | 62 | 60 | Coonrad-Morrey¶ | Linked | Cemented | V | V | N/A | N/A | |
Qureshi et al,35 2010 | Case series | 22 | 56 | 142.8 | Kudo type 5** | Unlinked | Cemented | V | V | V | V |
Ishii et al,36 2012 | Case series | 35 | 66 | 75.6 | GSB III prosthesis¶¶ | Linked | Cemented | V | V | N/A | N/A |
Nishida et al,37 2014 | Case series | 54 | 59 | 151.2 | Stemmed Kyocera type I**** | Unlinked | Cemented | V | V | V | V |
Nishida et al,38 2014 | Case series | 17 | 64 | 47.7 | PROSNAP elbow prosthesis§§§ | Linked | Cemented | V | V | V | N/A |
Mukka et al,39 2015 | Case series | 25 | 64 | 54 | Discovery system¶¶¶ | Linked | Cemented | V | V | V | N/A |
Ogino et al,40 2015 | Case series | 55 | 64 | 90 | Coonrad-Morrey¶ | Linked | Cemented | N/A | N/A | V | V |
Discovery system¶¶¶ | |||||||||||
Celli et al,41 2016 | Case series | 15 | 59 | 38 | Coonrad-Morrey¶ | Linked | Cemented | V | V | V | V |
Sanchez-Sotelo et al,1 2016 | Case series | 461 | 64 | 108 (median) | Coonrad-Morrey¶ | Linked | 457 Cemented, 4 Cementless | V | V | N/A | N/A |
Toulemonde et al,7 2016 | Cohort study | 45 | 63 | 62 | Coonrad-Morrey¶ | Linked | Cemented | V | V | V | V |
Williams et al,42 2016 | Case series | 22 | 59 | 64 | Coonrad-Morrey¶ | Linked | Cemented | V | V | N/A | N/A |
Hänninen et al,43 2017 | Case series | 55 | 57 | 64 | Discovery system¶ | Linked | Cemented | V | V | V | V |
Kodama et al,44 2017 | Case series | 41 | 58.9 | 141 | Kudo type 5** | Unlinked | Hybrid | V | V | V | V |
Nishida et al,45 2017 | Case series | 17 | 54.8 | 128.4 | JACE††† | Unlinked | Cementless | V | V | V | V |
Nishida et al,46 2018 | Case series | 87 | 62 | 108 | JACE† | Unlinked | Cemented | V | V | V | V |
Pham et al,47 2018 | Case series | 54 | 60 | 84 | Coonrad-Morrey¶ | Linked | Cemented | V | V | V | V |
Kondo et al,48 2019 | Case series | 75 | 64 | 62.4 | Niigata-Senami-Kyocera modular**** | Unlinked | Cemented | V | V | V | N/A |
-
*
Description of implant failures, including aseptic loosening, septic loosening, or instability.
-
†
Description of complications, including triceps disruption, ulnar neuropathy, posterior interosseous neuropathy, radial neuropathy, intraoperative fracture, intraoperative stem penetration, postoperative fracture, surgical site infection, deep infection, heterotopic ossification, or stiffness.
-
‡
Range of motion.
-
§
Mayo elbow performance score(MEPS).
-
¶
Zimmer Biomet, Warsaw, Indiana, USA.
-
**
Biomet Ltd, Swindon, UK.
-
††
Biomet Ltd, South Glamorgan, UK.
-
‡‡
Stryker Howmedica, Newbury, UK.
-
§§
Johnson & Johnson, New Brunswick, New Jersey, USA.
-
¶¶
Allo Pro AG, Baar, Switzerland.
-
***
Biomet Ltd, Swansea, UK.
-
†††
Kyocera and Kobe Steel Ltd., Kyoto, Japan.
-
‡‡‡
Kyocera Ltd, Kyoto, Japan.
-
§§§
Kyocera Medical, Osaka, Japan.
-
¶¶¶
Biomet, Warsaw, Indiana, USA.
-
****
Kyocera, Kyoto, Japan.
-
N/A, not available; TEA, total elbow arthroplasty.
The quality of the methodology of the studies was assessed independently by two authors (TFC, SWT) using the NIH Quality Assessment Tool for Case Series Studies.49 The maximum possible score on this scale is 9. ‘Good’ was defined as a score of between 7 and 9, ‘fair’ as a score between 4 and 6, and ‘poor’ as a score of < 4 (Table II). If there were disagreements, a third author was consulted.
Table II.
Criteria | 1. Was the study question or objective clearly stated? | 2. Was the study population clearly and fully described, including a case definition? | 3. Were the cases consecutive? | 4. Were the subjects comparable? | 5. Was the intervention clearly described? | 6. Were the outcome measures clearly defined, valid, reliable and implemented consistently across all study participants? | 7. Was the length of follow-up adequate? | 8. Were the statistical methods well-described? | 9. Were the results well-described? | Quality of the cohort study* (score) |
---|---|---|---|---|---|---|---|---|---|---|
Lo et al,13 2003 | Y | Y | NR | Y | Y | Y | N | Y | Y | Good (7) |
Potter et al,14 2003 | Y | Y | Y | Y | Y | Y | Y | Y | Y | Good (9) |
Reinhard et al,15 2003 | Y | Y | NR | Y | Y | Y | Y | Y | Y | Good (9) |
Samijo et al,16 2003 | Y | Y | NR | Y | Y | Y | Y | Y | Y | Good (8) |
Van Der Lugt et al,17 2004 | Y | Y | CD | Y | Y | Y | Y | Y | Y | Good (8) |
Willems et al,42 2004 | Y | Y | CD | Y | Y | Y | N/A | Y | Y | Good (7) |
Khatri and Stirrat,19 2005 | Y | Y | CD | Y | Y | Y | N/A | Y | Y | Good (7) |
Lee et al,20 2005 | Y | Y | CD | Y | Y | Y | Y | Y | Y | Good (8) |
Little et al,21 2005 | Y | Y | Y | Y | Y | Y | CD | Y | Y | Good (8) |
Ovesen et al,22 2005 | Y | Y | CD | Y | Y | Y | Y | Y | Y | Good (8) |
Jensen et al,23 2006 | Y | N | CD | Y | Y | Y | Y | Y | Y | Good (7) |
Landor et al,24 2006 | Y | N | Y | Y | Y | Y | N | Y | Y | Good (7) |
Mori et al,25 2006 | Y | Y | CD | Y | N/A | Y | Y | N/A | Y | Fair (6) |
Rauhaniemi et al,26 2006 | Y | Y | CD | Y | Y | Y | Y | N | Y | Good (7) |
Thillemann et al,27 2006 | Y | Y | CD | Y | Y | Y | Y | Y | Y | Good (8) |
Brinkman et al,28 2007 | Y | Y | CD | Y | Y | Y | Y | Y | Y | Good (8) |
Cesar et al,29 2007 | Y | Y | CD | Y | Y | Y | Y | Y | Y | Good (8) |
Skyttä et al,30 2008 | Y | Y | Y | Y | Y | Y | Y | Y | Y | Good (9) |
Tachihara et al,31 2008 | Y | Y | CD | Y | Y | Y | CD | Y | Y | Good (7) |
Amirfeyz and Blewitt,32 2009 | Y | Y | CD | Y | Y | Y | CD | Y | Y | Good (7) |
Kleinlugtenbelt et al,33 2010 | Y | Y | CD | Y | Y | Y | Y | Y | Y | Good (8) |
Prasad and Dent,34 2010 | Y | CD | CD | CD | CD | Y | CD | Y | Y | Fair (4) |
Qureshi et al,35 2010 | Y | Y | Y | Y | Y | Y | Y | N | Y | Good (8) |
Ishii et al,36 2012 | Y | Y | CD | Y | Y | Y | Y | Y | Y | Good (8) |
Nishida et al,37 2014 | Y | Y | CD | CD | Y | Y | Y | N | Y | Fair (6) |
Nishida et al,38 2014 | Y | N | CD | CD | Y | Y | Y | N | Y | Fair (5) |
Mukka et al39 2015 | Y | Y | Y | Y | Y | Y | N | Y | Y | Good (8) |
Ogino et al40 2015 | Y | Y | Y | Y | Y | Y | Y | Y | Y | Good (9) |
Celli et al,41 2016 | Y | Y | Y | Y | Y | Y | Y | Y | Y | Good (9) |
Sanchez-Sotelo et al1 2016 | Y | Y | Y | Y | Y | Y | Y | Y | Y | Good (9) |
Toulemonde et al,7 2016 | Y | N | Y | Y | Y | Y | Y | Y | Y | Good (8) |
Williams et al,42 2016 | Y | N | CD | CD | N | Y | CD | N | Y | Poor (3) |
Hänninen et al,43 2017 | Y | N | CD | CD | Y | Y | Y | Y | Y | Fair (6) |
Kodama et al,44 2017 | Y | Y | CD | Y | Y | Y | Y | Y | Y | Good (8) |
Nishida et al,45 2017 | Y | Y | CD | Y | N | Y | CD | Y | Y | Fair (6) |
Nishida et al,46 2018 | Y | Y | CD | Y | Y | Y | Y | Y | Y | Good (8) |
Pham et al,47 2018 | Y | Y | CD | Y | Y | Y | Y | Y | Y | Good (8) |
Kondo et al,48 2019 | Y | Y | CD | Y | Y | Y | Y | Y | Y | Good (8) |
-
*
The maximum possible score on this scale is 9. ‘Good’ was defined as a total score of 7 to 9; ‘fair’ as a score 4 to 6, and ‘poor’ as a score of less than 4.
-
CD, cannot determine; N, no; N/A, not available; NR, not reported; Y, yes.
Statistical analysis
A meta-analysis of proportions was conducted using the Freeman-Tukey analysis under random-effects model to calculate pooled estimates with a 95% confidence interval (CI). A random-effects model was used for differences among studies such as patient characteristics, the design of the prosthesis, different surgical technique, and methodology. For potential factors that may lead to implant failure, complications, or improved functional performance, a standard multivariate linear regression analysis (β) was performed. All analyses were completed with Comprehensive Meta-Analysis (CMA) v. 3 (Biostat, Englewood, New Jersey, USA) and significance was defined as a p < 0.05.
Results
After removing duplicate studies, 456 were identified for review. Those not in English were removed and 387 were excluded after reviewing the title and abstract. Another 21 were excluded after reading the full text as the study did not meet the inclusion criteria. Five evaluated different designs of prosthesis and each was divided into groups based on the design that was reported. After exclusion, a total of 38 studies were included1,7,39-48 (Figure 1).
Baseline characteristics
A total of 2,118 patients were included. The mean follow-up was 80.9 months (28.2 to 156.0). The mean age was 61.0 years (42.6 to 67.0) and 1,705 patients (80.5%) were female. A total of 1,120 elbows (46.0%) were treated with a linked prosthesis and 2,206 elbows (90.6%) were cemented.
Implant failure rate
A total of 36 studies, with 2,063 patients, reported implant failure rates. The pooled rate was 16.1% (95% CI 0.128 to 0.200) (Figure 2, Table III). A multivariate linear regression analysis showed that younger age (β = -0.08, CI -0.16 to -0.01) and an unlinked design (β = -0.72, CI -1.27 to -0.18) were associated with a higher risk of failure. We further analyzed the pooled incidence (Table III) and risk factor for each type of failure (Table IV).
Fig. 2
Table III.
Variable | Rate or mean value (95% CI) |
---|---|
Implant failure | 0.161 (0.128 to 0.200) |
Aseptic loosening | 0.095 (0.071 to 0.124) |
Septic loosening | 0.035 (0.028 to 0.045) |
Instability | 0.053 (0.038 to 0.074) |
Bushing wear, axle failure or component fracture | 0.026 (0.019 to 0.035) |
Total complications | 0.245 (0.203 to 0.293) |
Ulnar neuropathy | 0.085 (0.057 to 0.125) |
Wound healing problems | 0.076 (0.039 to 0.144) |
Deep infection | 0.055 (0.042 to 0.071) |
Postoperative fracture | 0.052 (0.041 to 0.065) |
Triceps disruption | 0.032 (0.019 to 0.055) |
Range of motion, ° | |
Flexion | 131.5 (124.2 to 138.8) |
Extension | 29.3 (26.8 to 31.9) |
Pronation | 74 (67.8 to 80.2) |
Supination | 72.5 (69.5 to 75.5) |
Arc of ROM | 104.5 (100.3 to 108.6) |
MEPS, points | 89.3 (86.9 to 91.6) |
-
CI, confidence interval; MEPS, Mayo Elbow Performance Score; ROM, range of motion.
Table IV.
Independent variable | β-coefficient (95% CI) | p-value |
---|---|---|
Implant failure | ||
Age | -0.08 (-0.16 to -0.01) | 0.034 |
Female sex | 0.60 (-1.27 to 2.47) | 0.529 |
Cemented fixation | -0.09 (-0.89 to 0.71) | 0.830 |
Linked design | -0.72 (-1.27 to -0.18) | 0.010 |
Aseptic loosening | ||
Age | -0.01 (-0.11 to 0.08) | 0.757 |
Female sex | 2.34 (0.04 to 4.64) | 0.047 |
Cemented fixation | -0.51 (-1.36 to 0.35) | 0.246 |
Linked design | -1.02 (-1.7 to -0.34) | 0.003 |
Septic loosening | () | |
Age | -0.02 (-0.12 to 0.08) | 0.680 |
Female sex | -0.33 (-2.84 to 2.17) | 0.795 |
Cemented fixation | 0.81 (-0.63 to 2.25) | 0.270 |
Linked design | -0.31 (-0.92 to 0.29) | 0.314 |
Instability | () | |
Age | -0.14 (-0.24 to -0.04) | 0.005 |
Female sex | 0.07 (-2.55 to 2.7) | 0.957 |
Cemented fixation | -0.2 (-1.23 to 0.82) | 0.696 |
Linked design | -0.8 (-1.87 to 0.04) | 0.061 |
Bushing wear, axle failure or component fracture | ||
Age | -0.02 (-0.15 to 0.11) | 0.729 |
Female sex | 1.45 (-3.07 to 5.97) | 0.530 |
Cemented fixation | 1.65 (0.34 to 2.96) | 0.013 |
Linked design | -0.68 (-1.65 to 0.28) | 0.165 |
Total complications | ||
Age | -0.13 (-0.2 to -0.06) | <0.001 |
Female sex | -1.15 (-2.89 to 0.59) | 0.196 |
Cemented fixation | 0.11 (-0.66 to 0.88) | 0.781 |
Linked design | 0.00 (-0.46 to 0.47) | 0.994 |
Mayo Elbow Performance Score | ||
Age | 0.17 (- 0.57 to 0.91) | 0.649 |
Female sex | -0.31 (-24.86 to 24.25) | 0.980 |
Cemented Fixation | 15.53 (4.7 to 26.36) | 0.005 |
Linked design | -0.67 (-5.61 to 4.27) | 0.790 |
-
CI, confidence interval
Aseptic loosening
A total of 33 studies including 1,928 patients reported aseptic loosening rates. The pooled rate was 9.5% (95% CI 0.071 to 0.124) (Figure 3, Table III). A multivariate linear regression analysis showed that female patients (β = 2.34, 95% CI 0.04 to 4.64) and an unlinked design (β = -1.02, 95% CI -1.7 to -0.34) were risk factors for aseptic loosening (Table IV).
Fig. 3
Septic loosening
A total of 33 studies, including 1,979 patients, reported septic loosening rates. The pooled rate was 3.5% (95% CI 0.028 to 0.045) (Figure 4, Table III). A multivariate linear regression analysis did not reveal specific factors that were associated with a higher risk of septic loosening (Table IV).
Fig. 4
Instability
A total of 36 studies including 2,042 patients reported the rate of instability. The pooled rate was 5.3% (95% CI 0.038 to 0.074) (Figure 5, Table III). A multivariate linear regression showed that younger patients (β = -0.14, 95% CI -0.24 to -0.04) and a trend toward an unlinked design (β = -0.8, 95% CI -1.87 to 0.04) were risk factors for instability (Table IV).
Fig. 5
Bushing wear, axle failure, or component fracture
A total of 33 studies including 1,986 patients reported bushing wear, axle failure or implant fracture. The pooled rate was 2.6% (95% CI 0.019 to 0.035) (Figure 6, Table III). Multivariate linear regression analysis showed that cemented fixation (β = 1.65, 95% CI 0.34 to 2.96) was a risk factor for bushing wear, axle failure, and implant fracture (Table IV).
Fig. 6
Complications
A total of 36 studies including 2,008 patients reported complication rates. The pooled total complication rate was 24.5% (95% CI 0.203 to 0.293) (Figure 7, Table III). A multivariate linear regression analysis showed that younger age (β= -0.13, 95% CI -0.2 to -0.06) was a covariate associated with higher complication rates (Table IV). The most common perioperative complications were: ulnar neuropathy (134; 8.5%), wound healing problems (21; 7.6%), deep infection (71; 5.5%), fracture (74; 5.2%), and triceps disruption (23; 3.2%) (Table III).
Fig. 7
Clinical performance
A total of 24 studies including 1,132 patients reported ROM. The pooled mean postoperative ROM was: flexion 131.5° (124.2° to 138.8°), extension 29.3° (26.8° to 31.9°), pronation 74.0° (67.8° to 80.2°), and supination was 72.5° (69.5° to 75.5°). The mean arc of flexion-extension was 104.5° (100.3° to 108.6°) (Figures 8 to 12, Table III).
Fig. 8
Fig. 9
Fig. 10
Fig. 11
Fig. 12
A total of 18 studies including 613 patients reported the MEPS. The pooled mean MEPS was 89.3 (95% CI 86.9 to 91.6) (Figure 13, Table III). A multivariate linear regression analysis showed that a cemented prosthesis (β = 15.53, 95% CI 4.7 to 26.36) was associated with improved MEPS. (Table IV).
Fig. 13
Discussion
There are few systematic reviews discussing the outcome of TEA in patients with RA in the literature. We previously compared the results for patients with RA and traumatic OA after TEA. Those with RA had a higher risk of septic loosening (odds ratio (OR) 3.96, 95% CI 1.11 to 14.12), while there was an increased risk of bushing wear, axle failure, component disassembly, and component fracture in the post-traumatic group.50 The systemic involvement of RA with potent medications such as steroids and disease-modifying antirheumatic drugs (DMARDs) may hinder the recovery of patients with RA after arthroplasty.51 Despite these challenges, several improvements in surgical technique and implant design have allowed TEA to evolve into an effective treatment for end-stage arthritis. In this study, we reviewed 38 studies to determine the failure rate and associated risk factors that may predispose to failure. A previous comprehensive review evaluating TEA in RA was conducted by Little et al.24 This study included studies up to 2003, which is now 17 years ago. During the subsequent period, advances in medical treatment, modified surgical techniques, and improved implant designs have been introduced. Welsink et al4 performed a meta-analysis with emphasis on implant designs. However, they combined different aetiologies such as post-traumatic and degenerative conditions. Patients with different aetiologies have different baseline characteristics such as immune status, bone stock, ligamentous integrity, and age. Therefore, this study updates several significant parameters after TEA in patients with RA. At a mean follow-up of 80.9 months, we noted an implant failure rate of 16.1% with aseptic loosening being the most common mode of failure. The total complication rate was 24.5% and the mean MEPS score was 89.3. TEA continues to be an excellent form of treatment for patients with RA, but additional attention should be paid to younger patients and those receiving an unlinked prosthesis as several adverse outcomes have been associated with these two factors.
In previous studies, the implant failure rate after TEA was reported to be between 4% and 32%.4,9,52 Aseptic loosening was the most common mode of failure.4,11 The overall incidence of loosening ranged from 5% to 20%, and can vary according to the design of the implant.1,11 We noted a failure rate of 16.1% which is consistent with previous reports that also included patients with mixed aetiologies.9 Aseptic loosening (9.5%) remained the most common mode of failure. Currently, aseptic loosening is thought to be caused by either inadequate initial mechanical fixation or loss of biological fixation due to particle-induced osteolysis.53 Several authors have reported that loosening is due to the multidirectional forces exerted at the implant-cement-bone interfaces.9 We performed a regression analysis of potential risk factors and further identified younger age (β = -0.08, 95% CI -0.16 to -0.11) and unlinked TEAs (β = -0.72, 95% CI -1.27 to -0.18) as risk factors that may predispose to failure. Patients with RA underwent TEA at mean age of 61.0 years, which is consistent with previous reports.4,9 The trend for higher failure rates in younger patients can be attributed to the increased levels of activity in these patients,54 which increase PE wear ultimately resulting in revision surgery.55 In a cohort study, Sanchez-Sotelo et al1 noted a gradual increase in failures with the passage of time, further raising concerns about performing TEA in young patients. There are two main reasons for the higher rate of failure in those with an unlinked TEA. First, an unlinked TEA requires larger PE bearings with larger surfaces for microabrasions.9 Secondly, a higher rate of dislocation and failure is seen if unlinked TEAs are used in patients with suboptimal surrounding capsuloligamentous structures.9
A multivariate analysis noted that women (β = 2.34, 95% CI 0.04 to 4.64) and unlinked TEAs (β = -1.02, -1.7 to -0.34) were associated with an increased risk of aseptic loosening. Currently, there is limited literature on the possible causes of increased rates of aseptic loosening in women after TEA. We hypothesize that active RA may play a role in this finding. Sokka et al56 reported that women were more likely to have a higher disease activity with increased comorbidity based on the Core Data Set measures. As RA activity progresses, the bone erosion may cause loosening at the interfaces.57
Theoretically, unlinked designs should have lower rates of loosening given the relatively superior surrounding soft tissue envelope.58 However, comparative studies have shown mixed results.6,9,11 Some authors have hypothesized that accelerated wear may be due to increased microabrasions occurring with larger PE bearings.9 Furthermore, the mixed results can be explained by the different definitions used for aseptic loosening in different studies. For instance, some authors have further subdivided aseptic loosening into radiolucency and clinical loosening.11 Further high-level studies are required to determine the association between clinical loosening and implant designs.
Due to the systemic involvement of RA and the fragile soft-tissue envelope of the elbow, patients are at an increased risk of infection compared with the general population. In the current literature, the overall risk of infection for patients with RA undergoing arthroplasty ranges from 2% to 4% with a 1.8- to 4-fold increased risk of infection compared with patients with OA.51 However, most of the large studies evaluated total hip and knee arthroplasty, and few studies have discussed TEA in RA. In this study, the overall incidence of deep infection was 5.5%. Specifically, the need for a subsequent procedure such as debridement or removal of the prosthesis to manage septic loosening was 3.5%. Several authors have reported a higher infection rate for TEA compared with total hip and knee arthroplasty. Welsink et al4 reported an overall infection rate after TEA of 6.9% with a deep infection rate of 3.4% which is slightly lower than our findings. They, however, included all aetiologies including OA, RA, and post-traumatic conditions, which may account for the slightly lower incidence of severe infection. In the study conducted by Sanchez-Sotelo et al,1 which evaluated TEA in patients with RA, deep infection was diagnosed in 8%, with 2.3% requiring removal or revision TEA. Several measures have been taken to prevent infection after TEA. In particular, discontinuation of DMARDs and antibiotic-impregnated cement have shown promising results.9 With appropriate perioperative managements, TEA can be performed safely with only a small increase of infection rate despite the complex medical status of RA.
Instability
Due to the complex ligamentous-capsular structures around the elbow, instability after TEA continues to be a challenge.11 Unlinked TEAs have been associated with higher rates of instability.9 Several significant postoperative anatomical features have been described. Most notably, the trochlear notch has a diminished circumference leading to a shallow groove compared with the preoperative status.59 In addition, extensive soft tissue release, particularly of the collateral ligaments results in an unstable elbow and is more commonly seen in unlinked designs.59 In linked designs, a certain degree of motion is permitted, such as valgus-varus of the ulna, so that the elbow performs as a ‘sloppy-hinge’ joint.60 Since dislocation in a linked TEA represents failure of the axle locking mechanism or disassembly of the components, most authors have categorized instability in linked and unlinked TEAs as being different entities.11 With the variable definition of instability including dislocation, subluxation, disassembly etc., we noted a pooled mean incidence of 5.3%. In a systematic review, Little et al11 noted a 5% recurrent dislocation rate and instability in 14% of 3,618 patients. Similarly, Prkić et al9 reported an incidence of about 1% for all types of design, with only one of 9,308 patients with an linked TEA having a dislocation. We performed a regression analysis and determined that linked designs were negatively correlated with instability which confirms previous reports. This analysis also revealed younger age to be a risk factor for instability. The higher levels of activity in younger patients may cause increased stress in the soft tissues as well as increased PE wear. The combination of wear and loosening causes a higher incidence of revision surgery in younger patients.61 Therefore, some authors have recommended the use of non-replacement surgery such as debridement and interposition arthroplasty for these patients.61 In conclusion, a linked prosthesis appears to provide a more stable elbow which may correlate with better clinical performance for patients with RA.
Bushing wear, axle failure, or component fracture
Bushing wear is a common mode of failure, particularly in patients with long-term follow-up.52 In the large series reviewed by Sanchez-Sotelo et al1 , bushing wear was noted in 71 patients (23%) of the surviving elbows with a minimum of two years of follow-up (median 10 years (interquartile range (IQR) 2 to 30)). Despite this high incidence, only nine patients required revision. In another series with long-term follow-up (mean 11.3 years) of 15 patients after TEA, eight had evidence of bushing wear but only one required revision.52 In our study, the rate of bushing wear that required revision surgery was 2.6%, which is similar to previous reports.1,47,52 Several factors have been associated with bushing wear. The longevity of TEA is one of the limiting factors since it directly causes PE wear.62,63 Also, pre-existing deformity of the elbow and younger age at the time of surgery were also factors predisposing to early wear.63 Meanwhile, component fatigue fracture might be a consequence of bushing wear. Lee et al64 identified 47 patients (1.8%) with component fractures in 2,637 primary and revision TEAs. All 47 patients had periarticular osteolysis on radiographs. Of the 39 patients in whom bushing wear was quantified, it was considered to be severe in 34. In a well-fixed TEA, a cantilever loading effect can occur at the periarticular part of a stem, leading to stress concentration at this junction, and most component fractures occurred in this area (57.4%, n = 27). They suggested that component fracture might result from osteolysis caused by bushing wear. In addition, younger patients with high activity, bone deficiency, weak soft-tissue stabilizers, and a prosthesis with a titanium alloy construct are additional factors which might predispose to stem fractures.65,66 Interestingly, age was not identified as a risk factor for bushing wear and component fractures in our study. This might be because of our relatively homogenous study population involving patients with RA who have undergone primary TEA, all of whom have lower activity levels and similar soft tissue and bone stock. Moreover, we noted that a cemented TEA predisposed to bushing wear (β = 1.65, 95% CI 0.34 to 2.96). In a comprehensive review conducted by Goldberg et al,62 all four modes of mechanical wear were reported in TEA. In particular, mode 3, which is secondary to cement debris destroying the PE surface, was also observed. However, they were not able to conclude that a cemented TEA predisposed to early wear. Currently, a cemented TEA remains the preferred option for most surgeons due to the high incidence of osteoporosis seen in patients with RA; 90.6% of the patients in this study received a cemented TEA.9
Complications
The most commonly seen complications in this study were ulnar neuropathy (8.5%), wound healing problems (7.6%), deep infection (5.5%), and fractures (5.2%). The incidence of ulnar nerve neuropathy varies widely, and is between 2% and 30%.4,11 Most patients who experience ulnar neuropathy have transient symptoms, but between 4% and 8% have permanent nerve damage.67 This high incidence of neuropathy may be related to surgical technique, vascular disruption secondary to tourniquet compression, thermal injury from cement, and RA-induced peripheral neuropathy.67 Spinner et al67 noted that four of ten patients with RA had peripheral neuropathy prior to TEA. Therefore, thorough electrophysiological evaluation may be required in patients with preoperative neurological symptoms.
Postoperative wound problems after TEA were noted in between 5.5% and 9% of patients.11,68 Despite this high incidence, Jeon et al68 noted that 88.7% of 97 patients were able to retain the prosthesis with only 11.3% requiring resection arthroplasty. In particular, RA was a risk factor, suggesting again that they are more vulnerable to serious infection. Appropriate prophylactic management in these patients may reduce wound complications and deep infections.
In the review conducted by Prkić et al,9 periprosthetic fractures were the third-most commonly encountered mode of failure after aseptic loosening and deep infection. This high incidence may be due to the weakened bone stock around TEA predisposing to fracture.9
In addition to the complications mentioned above, humeral and ulnar osteolysis, heterotopic ossification, intraoperative fractures, and axillary vein thrombosis have been reported after TEA.4,6,11,69
ROM and clinical performance
Although the primary goal of TEA is pain-relief in patients with end-stage arthritis (Larsen grade70 4 or grade 5), improvement in clinical performance (e.g. Disabilities of the Arm, Shoulder and Hand71 (DASH) scores and MEPS) and ROM remains critical. Morrey et al72 reported that the elbow can accomplish most daily activities with an arc of motion between 30° to 130° and 100° of forearm rotation (50° each of supination and pronation). The pooled mean ROM in this current study was 131.5°, 29.3°, 74.0°, and 72.5° for flexion, extension, supination, and pronation, respectively, suggesting that patients with RA can perform most daily activities after TEA. Dysfunction of the extensor mechanism due to triceps deficiency has been frequently discussed as a cause of limited movement after TEA.41 In our study, only 3.2% of the patients had triceps disruption.
In terms of clinical performance, the pooled mean MEPS was 89.3 points at a mean follow-up of 80.9 months. This finding is consistent with previous reports that TEA can lead to a satisfactory clinical performance in selected patients.9,21 A regression analysis revealed that cemented implants correlated with improved MEPS. Currently, most surgeons advocate the use of a cemented TEA mainly because of osteoporosis in these patients.6,10 In addition, loosening was less commonly seen with cemented implants which could partly explain the improved MEPS.10 Further studies with emphasis on cemented versus cementless implants are required to analyze the differences.
Limitations
This study has limitations. First, we only included studies that were written in English. Secondly, due to the nature of our research question, the level of evidence of the studies which were included was low (III or IV). Thirdly, we could only analyze factors including age, sex, cemented or cementless fixation, and linked or unlinked design that were clearly stated in most studies. Factors that might determine outcome including RA disease activity, the baseline activity level of patients, or surgeons’ experience could not be analyzed. We stratified all implants into linked or unlinked for analysis rather than to directly validate implant brands as risk factors because the brands were largely heterogenous in the included studies. Lastly, we included studies that were published over a time span of almost 17 years between 2003 and 2019. The studies may have several differences such as heterogenous designs, modified surgical techniques, and different follow-up times. Nonetheless, this study provides an updated review for physicians and revealed several differences compared with the comprehensive review performed by Little et al11 in 2005.
In conclusion, TEA continues to provide satisfactory results in patients with RA. In this comprehensive review, the overall implant failure rate was 16.1% and the complication rate was 24.5%. Aseptic loosening remains the most common mode of failure after TEA. Importantly, younger patients and unlinked TEAs were associated with implant failure while female sex correlated with aseptic loosening. These results can be of use when counselling patients about the expectations of TEA.
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Author contributions
T-F. A. Chou: Conceptualized the study, Performed the statistical analysis, Wrote and critically revised the manuscript.
H-H. Ma: Conceptualized the study, Carried out the literature search, Collected, analyzed, and interpreted the data, Performed the statistical analysis.
J-H. Wang: Conceptualized the study, Performed the statistical analysis, Wrote the manuscript.
S-W. Tsai: Conceptualized the study, Carried out the literature search, Collected, analyzed, and interpreted the data, Performed the statistical analysis, Wrote and critically revised the manuscript.
C-F. Chen: Wrote and critically revised the manuscript.
P-K. Wu: Performed the statistical analysis, Critically revised the manuscript.
W-M Chen: Performed the statistical analysis, Critically revised the manuscript.
Funding statement
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This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives (CC BY-NC-ND 4.0) licence, which permits the copying and redistribution of the work only, and provided the original author and source are credited. See https://creativecommons.org/licenses/by-nc-nd/4.0/.
This article was primary edited by J. Scott.