Implant migration and functional outcome of Reverse Shoulder Lateralized Glenosphere Line Extension System: a study protocol for a randomized controlled trial
Bibliographic record
Abstract
BACKGROUND: Inferior scapular notching is a complication unique to reverse shoulder arthroplasty. The most efficient technique to avoid inferior scapular notching has been reported to be lateralization of the glenoid offset. This study aims to compare radiological and functional outcomes of the DELTA Xtend® Reverse Shoulder System Lateralized Glenosphere Line Extension (intervention group) with the Standard DELTA Xtend® Reverse Shoulder System (control group). We hypothesize that the lateralization improves the patient outcome by decreasing the risk of inferior scapular notching without increasing the risk of migration and loosening of glenoid component. METHODS: In this randomized controlled trial, all Danish citizens with rotator cuff arthropathy or degeneration of the glenohumeral joint with severe posterior wear and allocated for a reverse total shoulder arthroplasty at the department of orthopaedic surgery at Herlev and Gentofte Hospital, Copenhagen University Hospital, will be considered for participation. The exclusion criteria are as follows: below 50 years of age, cognitive or linguistic impairment, insufficient glenoid bone stock, previous fracture in the upper extremity and autoimmune-mediated inflammatory arthritis. There will be included a total of 122 patients of which 56 will participate in the radiostereometric analysis. This number of patients allows 20% to drop out. The co-primary outcomes are the pattern and magnitude of the migration of the glenoid component assessed by radiostereometric analysis and the Western Ontario Osteoarthritis of the Shoulder index. The secondary outcomes are inferior scapular notching, patient-reported and functional outcomes (Oxford shoulder score, Constant-Murley score and pain), side effects and complications, changes in bone mineral density and economy. The included patients will be examined before the surgery, within 1 week and 3, 6, 12 and 24 months after. DISCUSSION: No previous studies have compared the conventional reverse shoulder arthroplasty with the lateralized reverse shoulder arthroplasty in a randomized controlled trial regarding migration and functional outcome. Furthermore, radiostereometric analysis has not been used to evaluate the migration of reverse shoulder arthroplasty in a randomized controlled trial. This study intends to determine which treatment has the most optimal outcome for the benefit of future patients with an indication for reverse shoulder arthroplasty. TRIAL REGISTRATION: The study has been notified to Pactius and has approval number P-2021-231. Furthermore, the study will be registered on Clinicaltrials.gov before starting the inclusion.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.007 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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 teacher head, 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".