NCT02195505

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
374

participants targeted

Target at P75+ for all trials

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

September 1, 2001

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2002

Completed
12.3 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2014

Completed
Last Updated

July 21, 2014

Status Verified

July 1, 2014

Enrollment Period

7 months

First QC Date

July 18, 2014

Last Update Submit

July 18, 2014

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (2)

  • Change in Lequesne index

    assessment of algo-functional severity of pathology

    up to 2 years

  • Change in Womac index

    assessment of symptom severity

    up to 2 years

Secondary Outcomes (1)

  • Medical costs related to knee osteoarthritis

    up to 2 years

Study Arms (2)

Synvisc®

Usual treatment of knee

nonsteroidal antiinflammatory drugs, antalgics

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

rheumatological practice

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2014

First Posted

July 21, 2014

Study Start

September 1, 2001

Primary Completion

April 1, 2002

Last Updated

July 21, 2014

Record last verified: 2014-07