Efficacy and safety of Hylan G-F 20 in shoulder osteoarthritis with an intact rotator cuff. Open-label prospective multicenter study.

OBJECTIVE

To evaluate the feasibility, safety, and symptomatic efficacy of intra-articular Hylan G-F 20 in patients with shoulder osteoarthritis and an intact rotator cuff.

METHODS

Open-label, prospective, multicenter study in patients with pain scores on a visual analog scale (VAS) between 40/100 and 90/100. An intra-articular injection of 2 ml of Hylan G-F 20 was given under fluoroscopic guidance. A second injection was given after 1, 2, or 3 months in the event of inadequate pain relief. The primary evaluation criterion was the VAS pain score 3 months after the first injection. Follow-up was 6 months.

RESULTS

Of 39 included patients, 33 received a first injection and, among these, 16 received a second injection; 29 patients completed the study. No serious or severe treatment-related adverse events were recorded. There were 10 mild or moderate adverse events in eight patients. The mean VAS pain score decreased from 61.2 mm at baseline to 37.1 mm after 3 months (P<0.001), and the decrease was larger in the subgroup that required a single injection.

CONCLUSION

This prospective study shows that treatment with one or two intra-articular injections of Hylan GF 20 in patients who have shoulder osteoarthritis and an intact cuff is feasible, safe, and probably effective. Viscosupplementation using Hylan G-F 20 may constitute a helpful treatment option in patients who have shoulder osteoarthritis with an intact rotator cuff.