NCT01810809

Hip Viscosupplementation: What is the Best Dosage?

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

Intraarticular injections have long been used to treat osteoarthritis. Viscosupplementation is a relatively new approach comprising the injection of hyaluronic acid into diarthrodial joints. The dosis regimen is well established for the knee joint, but there is still no consensus regarding the optimal dosage for hip viscosupplementation. Our objective is to determine the optimal dosis for hip viscosupplementation

Detailed description

Intraarticular injections have long been used to treat osteoarthritis. Viscosupplementation is a relatively new approach comprising the injection of hyaluronic acid into diarthrodial joints. Any osteoarthritic joint is eligible to this treatment modality, but the great majority of studies are for knee viscosupplementation. The dosis regimen is well established for the knee joint, but there is still no consensus regarding the optimal dosage for hip viscosupplementation. We will prospectively enroll 80 patients with hip osteoarthritis and will randomize them into four groups: Group zero will receive joint lavage with saline injection. Group 1 will receive joint lavage with saline injection and 2 ml of Hylan GF-20 (1 ampoule of Synvisc Classic®). Group 2 will receive joint lavage with saline injection and 4 ml of Hylan GF-20 (2 ampoules of Synvisc Classic®). Group 3 will receive joint lavage with saline injection and 6 ml of Hylan GF-20 (3 ampoules of Synvisc Classic®). The Visual Analogic Scale of Pain (VAS), the Western Ontario and McMaster Universities Index (WOMAC®), and Lequesne questionnaires were completed at baseline and at Weeks 1, 4, 12, and 24. Our objective is to determine the optimal dosis for hip viscosupplementation

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
PROCEDURE	articular lavage with saline injection	Patients will receive articular lavage with saline injection
DRUG	1 ampoule of Hylan GF-20	Patients will receive viscosupplementation with 2ml (1 ampoule) of Hylan GF-20
DRUG	2 ampoules of Hylan GF-20	Patients will receive viscosupplementation with 4ml (2 ampoules) of Hylan GF-20
DRUG	3 ampoules of Hylan GF-20	Patients will receive viscosupplementation with 6ml (3 ampoules) of Hylan GF-20

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-06-01
• Completion: 2014-11-01
• First posted: 2013-03-14
• Last updated: 2013-09-11

Locations

1 site across 1 country: Brazil