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

U

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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