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

Knee Osteoarthritis Clinical Trial

— ORFEVRE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01884883
• Other study ID #: MAILLEFERT 2010
• Status: Completed
• Phase: N/A
• First received: June 18, 2013
• Last updated: June 21, 2013
• Start date: May 2010

Study information

• Verified date: June 2013
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• PROTEOR Internal unicompartmental knee brace

Locations

Country	Name	City	State
France	CHU de Dijon	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Evaluation of the functional capacities: KOOS questionnaire.		baseline	No
Secondary	Evaluation of the functional capacities: KOOS questionnaire.		baseline + 5 weeks	No