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Completed

NCT Number: NCT02765685

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

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Dijon Bourgogne

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

brace ODRA (PROTEOR company)

Device

Port of the orthosis ODRA during day during 12 months, Complement to their usual care. The subjects will have for instruction to wear the brace a minimum of 6 hours a day, 5 days a week, And to remove it during the rest periods in lengthened position.

Usual Care

Other

The patients will benefit only from the coverage proposed usually, by their regular doctor and according to the notices of the medical and paramedical specialists taking care of this pathology (physiotherapists, orthopaedic osteopaths, sports medicine physician, surgeon, rheumatologists, rehabilitative doctors, etc.). In the absence of recommendations on the modalities of coverage of the gonarthrose and in front of diverse clinical habits, the "usual" said coverage can be at the same time medicinal (anti-inflammatory, painkilling, …), non-medicinal (physiotherapy, port of an orthosis, …), even surgical, according to the influencers.

Primary outcomes

  1. Pain measured using a VAS (visual analogue scale) by the patient

    Time frame: 12 months

Secondary outcomes

  1. Ratio differential cost-utility

    Time frame: 12 months

  2. Evolution of pain measured by VAS in the form of a self-questionnaire

    Time frame: 6 months

  3. Evolution of the Function score- Everyday life of the KOOS (Knee injury and osteoarthritis outcome score) self-questionnaire

    Time frame: 12 months

  4. Evolution of quality of life measured by the AMIQUAL self-questionnaire

    Time frame: 12 months

  5. Evolution de overall disease activity measured by VAS

    Time frame: 12 months

  6. Consumption of care relative to the knee osteoarthritis

    Time frame: 12 months

    Surgical operation, injectable medicinal treatments and anti-osteoarthritic of slow action, care of Support

  7. Local or general adverse effects

    Time frame: 12 months

  8. Compliance with wearing the brace

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

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

Acronym: ERGONOMIE

Important dates

Study start
2015
Primary completion
2017
First posted
May 9, 2016
Registry last updated
Aug 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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