Evaluation of a Distraction-rotation Knee Unloader Brace in Patients With Medial Knee Osteoarthritis.
ORFEVRE
1 other identifier
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 18, 2013
CompletedFirst Posted
Study publicly available on registry
June 24, 2013
CompletedJune 24, 2013
June 1, 2013
1.6 years
June 18, 2013
June 21, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Baseline
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.
Baseline + 5 weeks
Secondary Outcomes (2)
Evaluation of the functional capacities: KOOS questionnaire.
baseline
Evaluation of the functional capacities: KOOS questionnaire.
baseline + 5 weeks
Study Arms (1)
Internal unicompartmental knee brace
OTHERInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Dijon
Dijon, 21079, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Francis Maillefert
CHU Dijon - Department of Rheumatology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2013
First Posted
June 24, 2013
Study Start
May 1, 2010
Primary Completion
December 1, 2011
Last Updated
June 24, 2013
Record last verified: 2013-06