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

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Device: PROTEOR Internal unicompartmental knee brace

• Registration Number: NCT01884883
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2011-12
• Status Verified: 2013-06
• Study First Submitted: 2013-06-18
• Study First Submitted QC: 2013-06-21
• Last Update Submitted: 2013-06-21
• Study First Posted: 2013-06-24
• Last Update Posted: 2013-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Internal unicompartmental knee brace	PROTEOR Internal unicompartmental knee brace	-

Primary Outcome Measures

Name	Time	Method
Pain score on visual analogic scale	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the functional capacities: KOOS questionnaire.	baseline + 5 weeks

Trial Locations

Locations (1)

CHU de Dijon; 🇫🇷 Dijon, France