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

Abstract

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.

• Authors: Eric Noël, Philippe Hardy, Frank-Wolfgang Hagena, Erick Laprelle, Felix Goebel, Christine Faure, Luc Favard, Pascal Gaudin, Ralph Christ, Christophe Baudot, Julia Dietl, Philippe Goupille
• Journal: Joint bone spine (Joint Bone Spine) Vol. 76 Issue 6 Pg. 670-3 (Dec 2009) ISSN: 1778-7254 [Electronic] France
• PMID: 19945321 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Biocompatible Materials
• hylan
• Hyaluronic Acid

Topics

• Adult
• Aged
• Aged, 80 and over
• Biocompatible Materials (administration & dosage)
• Female
• Health Status
• Humans
• Hyaluronic Acid (administration & dosage, analogs & derivatives)
• Injections, Intra-Articular
• Male
• Middle Aged
• Osteoarthritis (drug therapy, pathology, physiopathology)
• Pain (drug therapy, physiopathology)
• Pain Measurement
• Prospective Studies
• Quality of Life
• Rotator Cuff
• Shoulder Joint (pathology, physiopathology)
• Sickness Impact Profile
• Treatment Outcome