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

NCT02765685 | Completed

• 1 other identifier: ORNETTI 2013
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (8)

• 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

Study Arms (2)

ODRA

EXPERIMENTAL

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

usual care

ACTIVE COMPARATOR

Other: Usual care

Interventions

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.

ODRA

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.

ODRA; usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2016
• First Posted: May 9, 2016
• Study Start: February 1, 2015
• Primary Completion: July 1, 2017
• Last Updated: August 22, 2018

Record last verified: 2018-08

Locations

FR (1)