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

U

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

21 participants in 1 patient group

Internal unicompartmental knee brace
Other group
Treatment:
Device: PROTEOR Internal unicompartmental knee brace

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems