A Study of the Safety and Efficacy of Synvisc in Patients With Symptomatic Ankle Osteoarthritis

Genzyme

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis

Treatments: Device: Synvisc (hylan G-F 20)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00131768

SYNV-003-02

Details and patient eligibility

About

This clinical study is to evaluate the safety and efficacy of Synvisc in patients with symptomatic ankle osteoarthritis (OA). Patients will be given Synvisc, with the possible administration of a second injection where insufficient symptomatic pain relief was experienced during the initial 3 months follow up period.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with symptomatic OA pain of ankle (talo-crural)

Exclusion criteria

• Patients with current or prior conditions or treatments that would impede measurements of efficacy or safety

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)