A multicenter, prospective 2-year analysis of the Sidus stem-free shoulder arthroplasty system
Bibliographic record
Abstract
Background The purpose of this multicenter, prospective study was to evaluate the efficacy and safety of a stemless total shoulder arthroplasty compared with a traditional stemmed control. Methods Ninety-five shoulders were selected for participation in this Food and Drug Administration investigational device exemption clinical trial and underwent stemless total shoulder arthroplasty. Subjects returned for follow-up at 6 weeks, 6 months, 12 months, and 2 years postoperatively. Outcome measures included pain; range of motion; American Shoulder and Elbow Surgeons, Western Ontario Osteoarthritis of the Shoulder, and Short Form 12 scores; and radiographic review. Baseline data were compared with 2-year follow-up data to determine the rate of composite clinical success compared with the stemmed control. Results All outcome assessments demonstrated significant improvements ( P ≤ .007). The mean American Shoulder and Elbow Surgeons score improved from 20 to 89 ( P < .0001), and the mean shoulder pain score decreased from 8.3 ± 1.6 to 0.7 ± 1.5 ( P < .0001). The mean Western Ontario Osteoarthritis of the Shoulder score decreased from 1443 ± 256 to 203 ± 267 ( P < .0001). On the Short Form 12, the mean physical health score increased from 33 ± 7 to 48 ± 9 ( P < .0001) and the mean mental health score increased from 50 ± 13 to 54 ± 8 ( P = .007). Mean active forward elevation increased from 97° ± 27° to 143° ± 25° ( P < .0001), and mean active external rotation increased from 21° ± 16° to 53° ± 18° ( P < .0001). Kaplan-Meier analysis showed an implant survivorship rate of 98% at 2 years. The composite clinical success rate was 87% compared with 85% for the stemmed control. Conclusions This study showed that a stemless rough-blasted humeral implant with metaphyseal bone fixation provides good clinical and radiographic outcomes and survivorship at 2 years, with outcomes comparable to a traditional stemmed implant.
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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 | 0.002 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 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 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".