Hip Viscosupplementation: What is the Best Dosage? (Hip VS)

University of Sao Paulo General Hospital

Status and phase: Unknown; Phase 4

Conditions: Osteoarthritis

Treatments: Drug: 2 ampoules of Hylan GF-20; Drug: 3 ampoules of Hylan GF-20; Drug: 1 ampoule of Hylan GF-20; Procedure: articular lavage with saline injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01810809

0255/10

Details and patient eligibility

About

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

Full 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

Enrollment: 80 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 4 patient groups

Articular Lavage

Active Comparator group

Description:

Patients from Group Zero will receive articular lavage with saline injection

Treatment:

Procedure: articular lavage with saline injection

Group 1

Experimental group

Description:

Patients from Group 1 will receive articular lavage with saline injection and viscosupplementation with 2ml (1 ampoule) of Hylan GF-20

Treatment:

Procedure: articular lavage with saline injection

Drug: 1 ampoule of Hylan GF-20

Group 2

Experimental group

Description:

Patients from Group 2 will receive articular lavage with saline injection and viscosupplementation with 4ml (2 ampoules) of Hylan GF-20

Treatment:

Procedure: articular lavage with saline injection

Drug: 2 ampoules of Hylan GF-20

Group 3

Experimental group

Description:

Patients from Group 3 will receive articular lavage with saline injection and viscosupplementation with 6ml (3 ampoules) of Hylan GF-20

Treatment:

Procedure: articular lavage with saline injection

Drug: 3 ampoules of Hylan GF-20