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 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 | 0.003 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 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".