A MULTICENTRE, RANDOMIZED, CONTROLLED TRIAL COMPARING A SECOND-GENERATION UNCEMENTED TRABECULAR METAL-BACKED WITH A CEMENTED POLYETHYLENE GLENOID COMPONENT IN TOTAL SHOULDER ARTHROPLASTY: FIVE-YEAR RESULTS
Bibliographic record
Abstract
Previously, we reported early findings (two-year) from a randomized controlled trial comparing a second-generation uncemented trabecular metal (TM) glenoid versus cemented polyethylene glenoid (POLY) in patients undergoing a total shoulder arthroplasty (TSA). The purpose of the current study is to report medium-term (five-year) results from this trial. Approval to conduct this multi-centre randomized trial was obtained from the appropriate institutional ethics boards. Five fellowship-trained surgeons from three centres participated. Patients 18–79 years with a primary diagnosis of glenohumeral osteoarthritis were screened for eligibility. Ineligibility criteria included: significant glenoid bone loss; major joint trauma; avascular necrosis; chronic dislocation; rotator cuff or inflammatory arthropathy; massive rotator cuff tear; previous shoulder surgery; muscle paralysis; Charcot arthropathy; life expectancy Of the 104 patients consented, 93 were randomized (46 TM; 47 POLY). There were no group differences at baseline (TM: 66.5yo (SD6.4); 24M/22F and POLY: 68.4yo (SD5.5); 23M/24F). No significant or clinically important differences were found with patient-reported outcomes, range of motion, or strength between groups at five-years postoperative. All outcomes in both groups improved significantly from baseline however, only minor improvements were observed between two- and five-years. With respect to the primary outcome (WOOS), the mean (SD) scores at baseline, two- and five-years were: TM: 32 (21), 92 (13), 93 (11) and POLY: 27 (15), 93 (11) and 93 (10), respectively. Metal debris was observed in 11 (23.9%) patients, but outcomes were not negatively impacted. Debris severity was minor (Grade 1 = 9pts; Grade 2 = 2pts) and remained stable in all but one patient who progressed from Grade 1 (years two-four) to Grade 2 in year five. Seven patients in each group experienced a complication. Of these, 6 (13%) in the TM and 4 (8.5%) in the POLY required a re-operation or revision. Only one patient experienced a glenoid-related complication requiring revision; this patient was in the TM group and had glenoid loosening due to infection. No catastrophic glenoid implant failures were observed. At five-years postoperative, there were no statistically or clinically significant differences between the two implants with respect to patient-reported outcomes, shoulder function, and complication rates. There were no catastrophic failures of the second-generation TM glenoid component. 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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.006 | 0.007 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.004 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".