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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PROTEOR Internal unicompartmental knee brace
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Dijon

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Internal unicompartmental knee brace

Arm Description

Outcomes

Primary Outcome Measures

Pain score on visual analogic scale
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.
Pain score on visual analogic scale
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.

Secondary Outcome Measures

Evaluation of the functional capacities: KOOS questionnaire.
Evaluation of the functional capacities: KOOS questionnaire.

Full Information

First Posted
June 18, 2013
Last Updated
June 21, 2013
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT01884883
Brief Title
Evaluation of a Distraction-rotation Knee Unloader Brace in Patients With Medial Knee Osteoarthritis.
Acronym
ORFEVRE
Official Title
Evaluation of a Distraction-rotation Knee Unloader Brace in Patients With Medial Knee Osteoarthritis.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internal unicompartmental knee brace
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
PROTEOR Internal unicompartmental knee brace
Other Intervention Name(s)
trademark : " PROTEOR " : code name 2H-200
Primary Outcome Measure Information:
Title
Pain score on visual analogic scale
Description
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.
Time Frame
Baseline
Title
Pain score on visual analogic scale
Description
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.
Time Frame
Baseline + 5 weeks
Secondary Outcome Measure Information:
Title
Evaluation of the functional capacities: KOOS questionnaire.
Time Frame
baseline
Title
Evaluation of the functional capacities: KOOS questionnaire.
Time Frame
baseline + 5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Francis Maillefert
Organizational Affiliation
CHU Dijon - Department of Rheumatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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