Hip Viscosupplementation: What is the Best Dosage?

Phase 4

• Conditions: Osteoarthritis
• Interventions: Procedure: articular lavage with saline injection; Drug: 1 ampoule of Hylan GF-20; Drug: 2 ampoules of Hylan GF-20; Drug: 3 ampoules of Hylan GF-20

• Registration Number: NCT01810809
• Lead Sponsor: University of Sao Paulo General Hospital

Brief 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

Study Timeline

• Study First Submitted: 2013-03-11
• Study First Submitted QC: 2013-03-11
• Study First Posted: 2013-03-14
• Study Start: 2013-04
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-10
• Last Update Posted: 2013-09-11
• Primary Completion: 2014-06
• Study Completion: 2014-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Met the American College of Rheumatology criteria for hip osteoarthritis
• No hip intraarticular injections in the last 6 months

Exclusion Criteria

• Severe reaction to the procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Articular Lavage	articular lavage with saline injection	Patients from Group Zero will receive articular lavage with saline injection
Group 1	articular lavage with saline injection	Patients from Group 1 will receive articular lavage with saline injection and viscosupplementation with 2ml (1 ampoule) of Hylan GF-20
Group 1	1 ampoule of Hylan GF-20	Patients from Group 1 will receive articular lavage with saline injection and viscosupplementation with 2ml (1 ampoule) of Hylan GF-20
Group 2	articular lavage with saline injection	Patients from Group 2 will receive articular lavage with saline injection and viscosupplementation with 4ml (2 ampoules) of Hylan GF-20
Group 2	2 ampoules of Hylan GF-20	Patients from Group 2 will receive articular lavage with saline injection and viscosupplementation with 4ml (2 ampoules) of Hylan GF-20
Group 3	articular lavage with saline injection	Patients from Group 3 will receive articular lavage with saline injection and viscosupplementation with 6ml (3 ampoules) of Hylan GF-20
Group 3	3 ampoules of Hylan GF-20	Patients from Group 3 will receive articular lavage with saline injection and viscosupplementation with 6ml (3 ampoules) of Hylan GF-20

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Instituto de Ortopedia e Traumatologia HC-FMUSP; 🇧🇷 São Paulo, SP, Brazil