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

June 21, 2013 updated by: Centre Hospitalier Universitaire Dijon
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • CHU de DIJON

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Internal unicompartmental knee brace
Device: PROTEOR Internal unicompartmental knee brace
Other Names:
  • trademark : " PROTEOR " : code name 2H-200

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score on visual analogic scale
Time Frame: Baseline
Pain was self-evaluated by patient on visual analogic scale (VAS: 0-100, 0 = no pain at all; 100 = worst pain appendix 1). Such pain is widely used and validated in the literature for the evaluation of knee osteoarthritis treatment outcome.
Baseline
Pain score on visual analogic scale
Time Frame: Baseline + 5 weeks
Pain was self-evaluated by patient on visual analogic scale (VAS: 0-100, 0 = no pain at all; 100 = worst pain appendix 1). Such pain is widely used and validated in the literature for the evaluation of knee osteoarthritis treatment outcome.
Baseline + 5 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the functional capacities: KOOS questionnaire.
Time Frame: baseline
baseline
Evaluation of the functional capacities: KOOS questionnaire.
Time Frame: baseline + 5 weeks
baseline + 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Investigators

  • Principal Investigator: Jean-Francis Maillefert, CHU Dijon - Department of Rheumatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

June 18, 2013

First Submitted That Met QC Criteria

June 21, 2013

First Posted (Estimate)

June 24, 2013

Study Record Updates

Last Update Posted (Estimate)

June 24, 2013

Last Update Submitted That Met QC Criteria

June 21, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAILLEFERT 2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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