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

Randomized Controlled Trial in Internal Compartment Knee Osteoarthritis: ODRA 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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: brace ODRA (PROTEOR company); Other: Usual care

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21079
    • Chu Dijon Bourgogne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: usual care	Other: Usual care; 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.
Experimental: ODRA	Device: brace ODRA (PROTEOR company); 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.; Other: Usual care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain measured using a VAS (visual analogue scale) by the patient	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratio differential cost-utility		12 months
Evolution of pain measured by VAS in the form of a self-questionnaire		6 months
Evolution of the Function score- Everyday life of the KOOS (Knee injury and osteoarthritis outcome score) self-questionnaire		12 months
Evolution of quality of life measured by the AMIQUAL self-questionnaire		12 months
Evolution de overall disease activity measured by VAS		12 months
Consumption of care relative to the knee osteoarthritis	Surgical operation, injectable medicinal treatments and anti-osteoarthritic of slow action, care of Support	12 months
Local or general adverse effects		12 months
Compliance with wearing the brace	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.	12 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: April 29, 2016
• First Submitted That Met QC Criteria: May 6, 2016
• First Posted (Estimate): May 9, 2016

Study Record Updates

• Last Update Posted (Actual): August 22, 2018
• Last Update Submitted That Met QC Criteria: August 20, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: ORNETTI 2013