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

University Hospital Center (CHU) Dijon Bourgogne

Status

Completed

Conditions

Knee Osteoarthritis

Treatments

Device: PROTEOR Internal unicompartmental knee brace

Study type

Interventional

Funder types

Other

Identifiers

NCT01884883

MAILLEFERT 2010

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

All

Ages

40 to 75 years old

Volunteers

No 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