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Internal Compartment Knee Osteoarthritis: ODRA (Orthosis Distraction and Rotation for osteoArthritis) Made-to-measure Hinged Knee Brace Versus Usual Care. — ERGONOMIE  

Knee Osteoarthritis Clinical Trial

Official title:
Randomized Controlled Trial in Internal Compartment Knee Osteoarthritis: ODRA Made-to-measure Hinged Knee Brace Versus Usual Care.

Clinical Trial Summary

This is a biomedical study on a medical device. 120 patients will participate in this study and will be split into 2 groups:

- 60 patients in the "usual care" group: these patients will receive the usual care proposed by their doctor for 12 months.

- 60 patients in the "ODRA" group: these patients will wear the ODRA brace for 12 months in addition to their usual care. They will be instructed to wear the brace for at least 6 hours per day, 5 days per week and to take it off during rest periods when lying down.

The distribution of patients in the groups will be randomized. For this study, patients will be followed for 12 months, spread over 3 visits: inclusion visit, follow-up visit at 6 months and 12 months.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02765685
Study type Interventional
Source Centre Hospitalier Universitaire Dijon
Contact
Status Completed
Phase N/A
Start date February 2015
View Details
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