Clinical trial NCT02765685: Internal Compartment Knee Osteoarthritis: ODRA (Orthosis Distraction and Rotation for osteoArthritis) Made-to-measure Hinged Knee Brace Versus Usual Care.
Official title: Randomized Controlled Trial in Internal Compartment Knee Osteoarthritis: ODRA Made-to-measure Hinged Knee Brace Versus Usual Care.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-05-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain measured using a VAS (visual analogue scale) by the patient
timeFrame: 12 months
Secondary outcomes:
measure: Ratio differential cost-utility
timeFrame: 12 months
measure: Evolution of pain measured by VAS in the form of a self-questionnaire
timeFrame: 6 months
measure: Evolution of the Function score- Everyday life of the KOOS (Knee injury and osteoarthritis outcome score) self-questionnaire
timeFrame: 12 months
measure: Evolution of quality of life measured by the AMIQUAL self-questionnaire
timeFrame: 12 months
measure: Evolution de overall disease activity measured by VAS
timeFrame: 12 months
measure: Consumption of care relative to the knee osteoarthritis
timeFrame: 12 months
measure: Local or general adverse effects
timeFrame: 12 months
measure: Compliance with wearing the brace
timeFrame: 12 months
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References: