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OpenTrials
Completed

NCT Number: NCT02021136

Efficacy and Safety of Rebel Reliever Brace in Patients With Symptomatic Medial Knee Osteoarthritis

The purpose of the study is to evaluate the superiority of Rebel Reliever® knee brace + standard treatment versus standard treatment alone in terms of last 24-hour pain relief after 6 weeks. in patients with medial knee osteoarthritis.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Euraxi Pharma

Joué-lès-Tours, Bp 80325, 37303, France

About this study

The main criteria is the evaluation of global knee pain during the last 24 hours at D 49 after the inclusion.

The response to the treatment will be evaluated during the inclusion visit (V1/D0) and after 6 weeks of treatment, during the following visit (V3/D49).

The level of the global pain of the patient during the last 24 hours will be collected by investigators with a VAS (0 mm = no pain ; 100mm = maximun pain) at each visit.

Who can participate

Healthy volunteers accepted: No

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

Main Inclusion Criteria:

  • Male or female over 18 years
  • BMI < or egal to 35kg/m2
  • symptomatic gonarthrose defined by a recurrent pain to the walk on 30 days during the last 2 months before the inclusion with radiological findings (grade II to IV on Kellgren-Lawrence)
  • diagnosis of medial femoro-tibial knee osteoarthrosis
  • patient with global pain intensity during the last 24hours > or egal 40 mm (EVA) at the day of selection

Main Exclusion Criteria:

  • femoro-patellar predominant arthrosis
  • septic arthritis
  • metabolic arthropathies
  • chronical rheumatismal diseases
  • other knee diseases
  • symptomatic coxarthrosis
  • controlateral gonathrosis with corticoids injections
  • any other serious disease which may interfere with the results
  • psychiatrics disorders
  • skin lesions or dermal pathologies
  • venous or arterial disorders
  • sensitivity disorders in the lower limbs (diabetes mellitus..)
  • paracetamol intolerance
  • hyaluronic acid or corticosteroid intra-articular injection in the last month prior to inclusion
  • on going knee viscosupplementation at inclusion
  • slow acting OA drugs (if started in the last 2 months prior to inclusion)
  • opioids, corticosteroids, or NSAIDs intake in the last 48 hours prior to inclusion
  • pregnant women of with no contraception
  • hepatic or renal insufficiency

Treatment and study plan

Rebel Reliever

Device

Rebel Reliever knee brace + usual antalgic treatment + physical exercises recommendations

Control

Other

Usual antalgic treatment + physical exercises recommendations

Primary outcomes

  1. Evolution of the last 24 hours knee pain (VAS)

    Time frame: Between Day 49 and Day 0

Secondary outcomes

  1. Evolution of knee pain on movement (VAS)

    Time frame: Between Day 49 and Day 0

    Evaluation with Visual Analysis Scale

  2. Evolution of Lequesne Algofunctional index score

    Time frame: Between D49 and Day 0

  3. Responder rate according to OARSI-OMERACT criteria

    Time frame: At Day 49

Other outcomes

  1. Percentage of patients with at least one adverse event or serious adverse event in each groups.

    Time frame: during the 6 weeks of brace wearing

Sponsors and collaborators

Lead sponsor

Thuasne

Industry

Registry information

Official study title

Efficacy and Safety of Rebel Reliever Brace in Medial Femorotibial Knee Osteoarthritis. Phase 3, Multicenters, Randomised and Controlled Study With 2 Parallel Groups.

Acronym: ROTOR

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 27, 2013
Registry last updated
Dec 30, 2016

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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