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

• Sponsor: Centre Hospitalier Universitaire Dijon (Other)
• Overall Status: Completed
• CT.gov ID: NCT01884883
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arm: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Device: PROTEOR Internal unicompartmental knee brace	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of a Distraction-rotation Knee Unloader Brace in Patients With Medial Knee Osteoarthritis.
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: Internal unicompartmental knee brace	Device: PROTEOR Internal unicompartmental knee brace; Other Names: trademark : " PROTEOR " : code name 2H-200

Outcome Measures

Primary Outcome Measures

1. 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.

2. Pain score on visual analogic scale [Baseline + 5 weeks]

   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 Outcome Measures

1. Evaluation of the functional capacities: KOOS questionnaire. [baseline]

2. Evaluation of the functional capacities: KOOS questionnaire. [baseline + 5 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Dijon	Dijon		France	21079

Sponsors and Collaborators

• Centre Hospitalier Universitaire Dijon

Investigators

• Principal Investigator: Jean-Francis Maillefert, CHU Dijon - Department of Rheumatology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire Dijon
• ClinicalTrials.gov Identifier: NCT01884883
• Other Study ID Numbers: MAILLEFERT 2010
• First Posted: Jun 24, 2013
• Last Update Posted: Jun 24, 2013
• Last Verified: Jun 1, 2013

• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

No Results Posted as of Jun 24, 2013