Best Effect of Viscosupplementation With Hyaluronic Acid and Triamcinolone in Patients With Knee Osteoarthritis. Prospective Randomized Study Between Two Different Applications Regimens

NCT01824485 Phase 4 COMPLETED

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

Details

Lead sponsor	University of Sao Paulo General Hospital
Phase	Phase 4
Status	COMPLETED
Enrolment	104
Start date	2013-03
Completion	2014-04

Conditions

• Osteoarthritis

Interventions

• viscosupplementation 1+1+1
• viscosupplementation 3 at once

Primary outcomes

• WOMAC — 6 months
  Pain and function assessment with WOMAC questionaire
• VAS — 6 months
  Pain assessment with Visual Analogic Scale (VAS)
• LEQUESNE — 6 months
  Pain and function assessment with Lequesne questionaire

Countries

Brazil