A multicenter, randomized controlled trial comparing a second-generation uncemented trabecular metal-backed vs. cemented polyethylene glenoid component in total shoulder arthroplasty: 5-year results.

BACKGROUND: Previously, we reported early (2-year) findings from a randomized controlled trial comparing a second-generation uncemented trabecular metal-backed (TM) glenoid vs. cemented polyethylene glenoid (POLY) in patients undergoing a total shoulder arthroplasty. The purpose of the current study is to report disease-specific quality of life, clinical, patient-reported, and radiographic outcomes at midterm (5-year) from this trial. METHODS: Five surgeons from 3 centers participated. Patients 18-79 years with a primary diagnosis of glenohumeral osteoarthritis were screened for eligibility. Randomization to an uncemented TM or cemented POLY glenoid was performed intra-operatively after adequate bone stock was confirmed. Study intervals were baseline, 2- and 5-year postoperative. The primary outcome was the Western Ontario Osteoarthritis Shoulder (WOOS) quality of life score. Secondary outcomes included the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, EuroQol-5 Dimensions, and 12-Item Short Form Health Survey scores and clinical and radiographic examinations. Radiographic images were reviewed for metal debris according to Endrizzi. Mixed effects repeated measures analysis of variance for within- and between-group comparisons were performed. RESULTS: Of the 104 patients who consented, 93 were randomized (46 TM; 47 POLY). There were no differences between groups at baseline (TM: mean age 66.5 years [standard deviation (SD) 6.4], 24 male and 22 female; and POLY: mean age 68.4 years [SD 5.5], 23 male / 24 female). Mean (SD) WOOS scores at baseline and 2 and 5 years were as follows: TM, 32 (21), 92 (13), and 93 (11); POLY, 27 (15), 93 (11), and 93 (10), respectively. No statistical or clinically relevant differences were noted with patient-reported outcomes between groups. Metal debris was observed in 11 (23.9%) patients, but outcomes were not negatively impacted, and debris severity was minor (grades 1 and 2). Complication rates were similar between groups (TM: 7 of 46 [15.2%], and POLY: 8 of 47 [17.0%]; P = .813). No aseptic glenoid failures were reported, but 1 patient in the TM group required revision because of infection. CONCLUSIONS: Our short-term (2-year) findings were maintained with longer follow-up. At 5 years postoperation, there were no statistically or clinically significant differences between an uncemented second-generation TM glenoid and a cemented polyethylene glenoid with respect to disease-specific quality of life or patient-reported outcomes. No glenoid implant failures were reported, and complication rates were similar between groups. Only one complication was glenoid related (1 infection in the TM group). Metal debris was observed in 23.9% of patients with a TM glenoid but did not negatively influence implant survival, patient-reported outcomes, or shoulder function.

Glenoid Component Position Does Not Affect Short-Term Clinical and Radiologic Outcomes in Total Shoulder Arthroplasty.

BACKGROUND: Malpositioning of the glenoid component in total shoulder arthroplasty (TSA) remains the primary source of loosening. The purpose of this study is firstly, to quantify postoperative glenoid component position in patients having a TSA and secondly, to explore whether glenoid component radiolucency is associated with glenoid position, clinical outcomes and patient-reported measures in the short-term (two year) follow-up period. METHODS: This study was a sub-study of a larger clinical trial that included patients who underwent a TSA and who were randomized into two different glenoid types with a minimum two-year follow-up period. Post-operative radiographic assessments (six weeks and two years) were used to measure glenoid component position (version, inclination, offset) and humeral head centering anterior-posterior (AP) and superior-inferior (SI), and to assess glenoid component radiolucent scoring (modified Lazarus). Pre-operative X-rays were used to measure glenoid version, inclination and Walch classification. Patient-reported measures (PROMs) included the EQ-5D health slider and the Western Ontario Osteoarthritis (WOOS) and American Shoulder and Elbow Surgeons (ASES) score and were captured at baseline and two years postoperative. Clinical outcomes including range of motion and complications were also documented. Statistical analysis included t-tests and regression modeling. RESULTS: Ninety-one patients with an average age of 69.9 ± 6.2 years were included in this study. Glenoid component position improved significantly in version (-19.4 ± 8.6° to -17.7 ± 8.5°; p < 0.045) and inclination (11.5 ± 7.1° to 5.9 ± 6.3°; p < 0.00001) from preoperative to six weeks postoperative. Glenoid component offset in SI and humeral head centering in AP remained unchanged throughout the follow-up. Radiolucency (Lazarus classification) was recorded in 21 cases (17.3%) with a Lazarus score of 1 (15 cases) and 2 (6 cases). The EQ-5D health slider, WOOS and ASES, and ROM confirmed continuous improvements from the preoperative scores to the two-year follow-up (p < 0.05). Regression models showed no correlation between glenoid component radiolucency at two years and the postoperative week six glenoid component position; however, female gender was a significant variable. CONCLUSION: Glenoid component changes from its original native glenoid were observed following TSA. Glenoid inclination was improved more than version from baseline, and the humeral head remained well-centered in AP and SI at two years. Radiolucency of the glenoid at two years is not negatively associated with PROMs or component position; however, female gender was identified as a significant predictor and warrants further investigation. Complications are not associated with glenoid position or radiolucency, but longer-term follow-up is required.

Two-year results of a multi-centre, randomized controlled trial comparing a second-generation uncemented trabecular metal-backed versus cemented polyethylene glenoid component in total shoulder arthroplasty.

AIMS: To report early (two-year) postoperative findings from a randomized controlled trial (RCT) investigating disease-specific quality of life (QOL), clinical, patient-reported, and radiological outcomes in patients undergoing a total shoulder arthroplasty (TSA) with a second-generation uncemented trabecular metal (TM) glenoid versus a cemented polyethylene glenoid (POLY) component. METHODS: Five fellowship-trained surgeons from three centres participated. Patients aged between 18 and 79 years with a primary diagnosis of glenohumeral osteoarthritis were screened for eligibility. Patients were randomized intraoperatively to either a TM or POLY glenoid component. Study intervals were: baseline, six weeks, six-, 12-, and 24 months postoperatively. The primary outcome was the Western Ontario Osteoarthritis Shoulder QOL score. Radiological images were reviewed for metal debris. Mixed effects repeated measures analysis of variance for within and between group comparisons were performed. RESULTS: A total of 93 patients were randomized (46 TM; 47 POLY). No significant or clinically important differences were found with patient-reported outcomes at 24-month follow-up. Regarding the glenoid components, there were no complications or revision surgeries in either group. Grade 1 metal debris was observed in three (6.5%) patients with TM glenoids at 24 months but outcomes were not negatively impacted. CONCLUSION: Early results from this RCT showed no differences in disease-specific QOL, radiographs, complication rates, or shoulder function between uncemented second-generation TM and cemented POLY glenoids at 24 months postoperatively. Revision surgeries and reoperations were reported in both groups, but none attributed to glenoid implant failure. At 24 months postoperatively, Grade 1 metal debris was found in 6.5% of patients with a TM glenoid but did not negatively influence patient-reported outcomes. Longer-term follow-up is needed and is underway. Cite this article: Bone Jt Open 2021;2(9):728-736.

Current concepts in instrumented knee-laxity testing.

BACKGROUND: Instrumented knee laxity testing devices have been used in both the clinical and research setting to evaluate persons with injuries about the knee. The ability to accurately and reproducibly quantify knee motion has the potential to greatly benefit both clinical practice and research by improving the validity of the research involving treatment of knee-ligament injuries. STUDY DESIGN: Systematic review; Level of evidence, 4. METHODS: A thorough literature review was performed, and a systematic overview is provided evaluating the methods of use and the evidence for the use of instrumented knee laxity testing devices. RESULTS: Devices that provide measurements of knee laxity have evolved during the past 30 years. The authors describe in detail their proper use and the best estimates of their validity based on clinical studies. CONCLUSION: The review suggests that the KT-1000 knee arthrometer and the Rolimeter provide best results when testing anterior laxity at the knee, whereas the Telos device is superior for the assessment of posterior laxity.

Anterior acromioplasty for the shoulder impingement syndrome: long-term outcome.

This study reanalyzes a group of patients who had anterior acromioplasty between 1975 and 1979, whose results were reported in 1990 at a mean 8-year follow-up, to identify any continuing problems or new complications, to assess the frequency of further surgery, and to define long-term outcome. Thirty-two patients were included. The mean follow-up was 25 years (range, 21 to 27 years). All had the impingement syndrome. At surgery, there was tendon and bursal inflammation with fibrosis in 28 shoulders and a small rotator cuff tear in 4. Five shoulders have required additional surgery: distal clavicle excision in one, revision anterior acromioplasty in one, and repair of a new rotator cuff tear in three. Of the shoulders, 23 (72%) were reported as having no or slight pain. Positive patient satisfaction was expressed in 28 (88%). Comparisons were made to the opposite shoulder in this older patient group. The mean within-patient difference between the operative shoulder and the opposite shoulder on the Simple Shoulder Test was 0.4, with scores of 8.9 for the operative side and 9.3 for the opposite side (P = .47). The mean difference in the American Shoulder and Elbow Surgeon's score was 8.6 points, with scores of 75 for the operative side and 83 for the opposite side (P = .02). The results of open acromioplasty for the impingement syndrome are usually maintained over time. Acromioplasty does not always prevent the need for subsequent rotator cuff surgery, but the rate of reoperation has remained relatively low in the long follow-up period.

Revision shoulder arthroplasty with positive intraoperative cultures: the value of preoperative studies and intraoperative histology.

Currently, there are no reported results of patients without overt infection who had a positive intraoperative culture during revision shoulder arthroplasty. We therefore reviewed the intraoperative and preoperative investigations as well as the postoperative course of these patients who had positive intraoperative cultures. We reviewed the results of 75 shoulders without overt infection that underwent revision shoulder arthroplasty at our institution between January 1, 1974 and December 31, 2002 who had positive intraoperative cultures. Preoperatively, the results of 67 (93%) of 72 white-blood-cell counts were negative, 64 (91%) of 70 polymorphonuclear percentage distributions were negative, and 36 (86%) of 42 samples of erythrocyte sedimentation rate were negative. C-reactive protein concentration was measured in 16 patients, of which 12 (75%) had negative results. Results of intraoperative histologic evaluations were negative in 67 (92%) of 73 patients. The most common pathogen cultured was Propionibacterium acnes in 45 of 75, followed by Staphylococcus epidermidis in 10 of 75. Another operation was necessary in 10 (13%) of 75 shoulders to decrease pain or improve function. The mean time to re-revision was 2.5 years. The data from this study suggest that there are no good preoperative or intraoperative investigations to detect who will have a positive intraoperative culture at the time of revision shoulder arthroplasty.

Complications of total shoulder arthroplasty: are they fewer or different?

There has been significant evolution of total shoulder arthroplasty design and improvement in technique over the past 25 years, but there is no information available as to whether this has translated into lower complication rates or different sorts of complications. The purpose of this study was to determine the contemporary complications and their frequency. Between 1990 and 2000, 431 total shoulder arthroplasties were performed with a cemented all-polyethylene glenoid component. Follow-up averaged 4.2 years. Complications were categorized by type as early or late and as minor, major, or major requiring reoperation. In total, 53 surgical complications occurred in 53 patients (12%). Of these, 32 were major complications (7.4%), with 17 of these requiring reoperation. Index complications in order of frequency included rotator cuff tearing, postoperative glenohumeral instability, and periprosthetic humeral fracture. Notably, glenoid and humeral component loosening requiring reoperation occurred in only 1 shoulder. Developing a complication was unrelated to diagnosis, previous surgery, age, sex, humeral head size, or cementing or not cementing the humeral component. Data from the contemporary patient group suggest that there are fewer complications of shoulder arthroplasty and less need for reoperation. Especially striking is the near absence of component revision because of loosening or other mechanical factors. Periprosthetic humeral fractures are more common; the explanation for this warrants further study.