Comparison of Two Application Regimens for Viscosupplementation

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Viscosupplementation by intra-articular injection of hyaluronate products has recently gained popularity as a treatment modality of gonarthritis.There is not, however, a consensus on the best method.Our objective is to evaluate what is the best dosage of viscosupplementation with hyaluronic acid (OSTEONIL®) associated with 1 ml (20 mg) of triamcinolone hexacetonide. One hundred and four patients with knee osteoarthritis (KOA) were divides into 2 groups of 52 patients each to receive either a single application of 3 ampoules of OSTEONIL® + 1ml of Hexacetonide of triamcinolone or three applications of 1 ampoule of OSTEONIL®, one per week for three weeks + 1ml of Hexacetonide of triamcinolone only in the first injection. Primary endpoint was clinical results expressed by Visual Analogic Scale of pain (VAS), Western Ontario and Mcmaster Universities (WOMAC) and Lequesne questionaires at one, three, six and 12 months after the procedure

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo General Hospital

Criteria

Inclusion Criteria:

• Met the American College of Rheumatology criteria for hip osteoarthritis

• No knee intraarticular injections in the last 6 months

Exclusion Criteria:

• Severe reaction to the procedure