Use of Synvisc® in Knee Osteoarthritis - Medico-economical Study

Completed

• Conditions: Osteoarthritis

• Registration Number: NCT02195505
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The USAGE study aims at assessing on a long-term period (two years in average) the outcome in clinical or economical term of patients with knee osteoarthritis (OA) treated or not with Synvisc®, in the 1139.4 clinical trial.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-09
• Primary Completion: 2002-04
• Status Verified: 2014-07
• Study First Submitted: 2014-07-18
• Study First Submitted QC: 2014-07-18
• Last Update Submitted: 2014-07-18
• Study First Posted: 2014-07-21
• Last Update Posted: 2014-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 374

Inclusion Criteria

• Patients have already been followed up on a nine-month period in a pragmatic medica-economical clinical trial (BI Trial No.: 1139.4)

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Lequesne index	up to 2 years	assessment of algo-functional severity of pathology
Change in Womac index	up to 2 years	assessment of symptom severity

Secondary Outcome Measures

Name	Time	Method
Medical costs related to knee osteoarthritis	up to 2 years