Efficacy and Safety of Hylan G‐F 20 for Symptomatic Glenohumeral Osteoarthritis: A Prospective, Pilot Study
Bibliographic record
Abstract
OBJECTIVE: To determine the safety and efficacy of 2 intra-articular, fluoroscopically guided hylan G-F 20 injections for painful glenohumeral osteoarthritis. DESIGN: This study was a prospective open-label pilot investigation with both U.S. Food and Drug Administration and institutional review board approval. SETTING: Private, outpatient practice within a tertiary care, university medical school. PARTICIPANTS: Thirty-six subjects with moderate to severe glenohumeral osteoarthritis, with pain (visual analog scale [VAS] 40 mm or greater) despite following a 3-month standard, nonsurgical treatment program. INTERVENTIONS: Two injections of 2 mL hylan G-F 20, under fluoroscopic guidance confirmed by arthrography, 2 weeks apart. No new treatments were allowed during the course of the study. Analgesics were discontinued 24 hours before visits. MAIN OUTCOME MEASUREMENTS: Data collected were radiographs; rotator cuff integrity as determined with magnetic resonance imaging; VAS for pain at rest, at night, and with activity; and shoulder-related quality of life (Western Ontario Rotator Cuff Index [WORC]). Subjects were re-evaluated after each injection and at 6 weeks, 3 months, and 6 months. Changes from baseline for VAS and WORC were recorded in Excel and analyzed using SPSS. Intent-to-treat analysis was performed. The type and severity of adverse events were recorded. RESULTS: Mean VAS at baseline was 63 mm (SD 14.5). Clinically (>or=20% improvement) and statistically significant improvements (P < .001) in VAS pain were seen at 6 weeks, 3 months, and 6 months. Mean improvement in WORC at 6 months was 16.5 (P < .01), with most gains in "lifestyle" and "emotion" questions. Age, gender, body mass index, and rotator cuff pathology did not correlate with response. Three subjects described heightened pain for a few days after injections. Three subjects reported greater pain at 6 months and were unsatisfied. Four experienced no effect of treatment. There were no inflammatory reactions. CONCLUSION: Two hylan G-F 20 injections improved pain and function, and should be considered as part of a multimodal shoulder osteoarthritis treatment program.
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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 | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| 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".