NCT00131768

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Nov 2003

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

March 18, 2015

Status Verified

March 1, 2015

First QC Date

August 17, 2005

Last Update Submit

March 17, 2015

Conditions

Osteoarthritis

Keywords

osteoarthritis of the anklemusculoskeletal

Outcome Measures

Primary Outcomes (1)

  • Pain relief

Interventions

Synvisc (hylan G-F 20)DEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Sportmedizinisches Institut Frankfurt am Main e.V. Orthopadie

Frankfurt, D-60528, Germany

Location

Johanna Etienne Krankenhaus

Neuss, D-41462, Germany

Location

Instituti Ortopedici Rizzoli

Bologna, 40136, Italy

Location

Ospedale Santa Chiara, Clinica Ortopedica, Universita di Pisa

Pisa, 56126, Italy

Location

Academisch Medisch Centrum

Amsterdam, 1100 DD, Netherlands

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Medical Monitor

    Genzyme, a Sanofi Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 17, 2005

First Posted

August 19, 2005

Study Start

November 1, 2003

Study Completion

February 1, 2006

Last Updated

March 18, 2015

Record last verified: 2015-03

Locations

IT(2)DE(2)NL(1)