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

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sportmedizinisches Institut Frankfurt am Main e.V. Orthopadie, Frankfurt, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Synvisc (hylan G-F 20)

Device

Primary outcomes

Pain relief

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Important dates

Study start: 2003
Study completion: 2006
First posted: Aug 19, 2005
Registry last updated: Mar 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed