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

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Device: brace ODRA (PROTEOR company); Other: Usual care

• Registration Number: NCT02765685
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2016-04-29
• Study First Submitted QC: 2016-05-06
• Study First Posted: 2016-05-09
• Primary Completion: 2017-07
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-20
• Last Update Posted: 2018-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Age ≥ 18

• Knee osteoarthritis (defined according to American College of Reumatology criteria):

  • radiological stage II, III or IV according to the Kellgren and Lawrence (KL) classification documented by a radiological examination in the previous 12 months.
  • Predominantly affecting the internal compartment (internal KL stage greater than external KL stage) and symptomatic with a Pain Visual Analogue Scale > 40/100 on the target side (side with the most symptomatic disease)

• Patients who have provided written consent

• Patients able to understand simple instructions, to read, write, and to give informed consent

• Patients with national health insurance cover

Exclusion Criteria

• Severe venous insufficiency in the lower limbs
• History of deep venous thrombosis in the lower limbs
• Inflammatory flare of knee osteoarthritis (synovial effusion) on the target side
• Person over 18 under guardianship or unable to provide consent
• Pregnant or breast-feeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ODRA	Usual care	-
usual care	Usual care	-
ODRA	brace ODRA (PROTEOR company)	-

Primary Outcome Measures

Name	Time	Method
Pain measured using a VAS (visual analogue scale) by the patient	12 months

Secondary Outcome Measures

Name	Time	Method
Evolution of the Function score- Everyday life of the KOOS (Knee injury and osteoarthritis outcome score) self-questionnaire	12 months
Ratio differential cost-utility	12 months
Evolution of pain measured by VAS in the form of a self-questionnaire	6 months
Evolution de overall disease activity measured by VAS	12 months
Evolution of quality of life measured by the AMIQUAL self-questionnaire	12 months
Consumption of care relative to the knee osteoarthritis	12 months	Surgical operation, injectable medicinal treatments and anti-osteoarthritic of slow action, care of Support
Local or general adverse effects	12 months
Compliance with wearing the brace	12 months	Average number of hours of port of the brace a day, the average number of days of port of the brace a week. The possible motives for non-observance will be brought together.; The patient will be considered compliant if he carries his brace at least 15 hours a week on average.

Trial Locations

Locations (1)

CHU Dijon Bourgogne; 🇫🇷 Dijon, France