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

University Hospital Center (CHU) Dijon Bourgogne

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Other: Usual care; Device: brace ODRA (PROTEOR company)

Study type: Interventional

Funder types: Other

Identifiers

NCT02765685

ORNETTI 2013

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 2 patient groups

ODRA

Experimental group

Treatment:

Device: brace ODRA (PROTEOR company)

Other: Usual care

usual care

Active Comparator group

Treatment:

Other: Usual care