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.

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.

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.

Single-strand reconstruction of the lateral ulnar collateral ligament restores varus and posterolateral rotatory stability of the elbow.

Because of a lack of biomechanical studies of lateral elbow ligament reconstruction in the literature, the initial stability afforded by 3 different techniques of lateral ulnar collateral ligament reconstruction was evaluated in 8 cadaveric elbows. The arm was mounted in a testing apparatus, and passive flexion was performed with the arm in varus and valgus orientations. A pivot shift test was performed with the arm in the vertical orientation. An electromagnetic tracking device was used to quantify motion pathways. After intact testing, each specimen underwent sectioning of the radial collateral and lateral ulnar collateral ligaments from the lateral epicondyle. Reconstruction of the lateral ulnar collateral ligament was performed in a randomized sequence, consisting of proximal single-strand, distal single-strand, and double-strand tendon grafts. Division of the radial collateral and lateral ulnar collateral ligaments from the lateral epicondyle caused a significant decrease in rotational stability when the pivot shift test was being performed (P <.0001). Varus-valgus stability also decreased after transection of the radial collateral and lateral ulnar collateral ligaments (P <.0001). Reconstruction of the lateral ulnar collateral ligament restored elbow stability to that of the intact state. There was no significant difference in stability between the single- and double-strand repair techniques (P >.05). This study demonstrates that both single- and double-strand reconstructions restore varus and posterolateral elbow stability and may be considered appropriate reconstructive procedures in patients with symptomatic insufficiency of the lateral ligaments of the elbow.