Premium
Efficacy and Safety of Hylan G‐F 20 for Symptomatic Glenohumeral Osteoarthritis: A Prospective, Pilot Study
Author(s) -
Brander Victoria Anne,
Gomberawalla Ameer,
Chambers Michelle,
Bowen Mark,
Nuber Gordon
Publication year - 2010
Publication title -
pmandr
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.617
H-Index - 66
eISSN - 1934-1563
pISSN - 1934-1482
DOI - 10.1016/j.pmrj.2010.02.010
Subject(s) - medicine , visual analogue scale , osteoarthritis , physical therapy , adverse effect , prospective cohort study , rotator cuff , quality of life (healthcare) , surgery , alternative medicine , nursing , pathology
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 (≥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.