Evaluation of a Distraction-rotation Knee Unloader Brace in Patients With Medial Knee Osteoarthritis.

NCT ID: NCT01884883

Last Updated: 2013-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Brief Summary

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The aim of this study is to confirm the biomechanical effects and evaluate functional benefits of a new knee brace combining valgus inducing effect on medial compartment and leg external rotation during the stance phase in patients with symptomatic medial knee osteoarthritis.

Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Internal unicompartmental knee brace

Group Type OTHER

PROTEOR Internal unicompartmental knee brace

Intervention Type DEVICE

Interventions

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PROTEOR Internal unicompartmental knee brace

Intervention Type DEVICE

Other Intervention Names

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trademark : " PROTEOR " : code name 2H-200

Eligibility Criteria

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Inclusion Criteria

* Patient understanding simple order and able to give written consent.
* Man or woman with age between 40 et 75 years
* Unilateral medial symptomatic knee osteoarthritis, defined using the American College of Rheumatology classification
* Radiologic grade II, III ou IV (Kellgren et Lawrence (KL) classification)
* Medial knee compartment (Medial K\&L g rade higher than lateral K\&L grade
* Knee pain \> 40/100 on visual analog scale and \<30/100 for the other
* No change in medical treatment for at least 3 months.
* Latest radiographic image \< 12 months before inclusion

Exclusion Criteria

* Patient without healthcare insurance.
* Inflammatory knee arthritis,
* Indication of knee surgery
* Pregnancy, breastfeeding
* Associate neurologic or orthopaedic affection that interferes with gait analysis
* Rapidly destructive arthritis.
* Alzheimer's disease, Parkinson's disease, motor neuronal disorders
* Patient under guardianship or tutelage
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Francis Maillefert

Role: PRINCIPAL_INVESTIGATOR

CHU Dijon - Department of Rheumatology

Locations

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CHU de Dijon

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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MAILLEFERT 2010

Identifier Type: -

Identifier Source: org_study_id

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