Efficacy and safety of hylan G-F 20 for symptomatic glenohumeral osteoarthritis: a prospective, pilot study.

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.