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.

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 2ml 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.

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 61.2mm at baseline to 37.1mm after 3 months (P<0.001), and the decrease was larger in the subgroup that required a single injection.

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.