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OpenTrials
Completed

NCT Number: NCT01884883

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

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Dijon

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PROTEOR Internal unicompartmental knee brace

Device

Other names: trademark : " PROTEOR " : code name 2H-200

Primary outcomes

  1. Pain score on visual analogic scale

    Time frame: 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

    Time frame: 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 outcomes

  1. Evaluation of the functional capacities: KOOS questionnaire.

    Time frame: baseline

  2. Evaluation of the functional capacities: KOOS questionnaire.

    Time frame: baseline + 5 weeks

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: ORFEVRE

Important dates

Study start
2010
Primary completion
2011
First posted
Jun 24, 2013
Registry last updated
Jun 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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