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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01884883

Acronym

ORFEVRE

Enrollment

Registered

2013-06-24

Start date

2010-05-31

Completion date

Unknown

Last updated

2013-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

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.

Interventions

DEVICEPROTEOR Internal unicompartmental knee brace

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Pain score on visual analogic scale	Baseline	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

Measure	Time frame
Evaluation of the functional capacities: KOOS questionnaire.	baseline

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026