Chin, J Shoulder Elbow Surg 2024 - 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 - Article Summary

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

Chin, Sasyniuk, et al.·J Shoulder Elbow Surg·2024·4 citations·RCT

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.
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.

Level of evidence: Level I; Randomized Controlled Trial; Treatment Study. Copyright remains with the authors and publisher.

Supplemental

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.

Chin, Sasyniuk, et al.J Shoulder Elbow Surg20244 citationsRCT