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

Osteoarthritis, Knee Clinical Trial

— ROTOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02021136
• Other study ID #: 2013-A00613-42
• Secondary ID: 2013-A00613-42
• Status: Completed
• Phase: Phase 3
• First received: October 14, 2013
• Last updated: December 29, 2016
• Start date: October 2013
• Est. completion date: September 2016

Study information

• Verified date: December 2016
• Source: Thuasne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection Authority
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: September 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Rebel Reliever
Rebel Reliever knee brace + usual antalgic treatment + physical exercises recommendations

Other:
• Control
Usual antalgic treatment + physical exercises recommendations

Locations

Country	Name	City	State
France	Euraxi Pharma	Joue-les-tours	Bp 80325

Sponsors (1)

Lead Sponsor	Collaborator
Thuasne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of patients with at least one adverse event or serious adverse event in each groups.		during the 6 weeks of brace wearing	Yes
Primary	Evolution of the last 24 hours knee pain (VAS)		Between Day 49 and Day 0	No
Secondary	Evolution of knee pain on movement (VAS)	Evaluation with Visual Analysis Scale	Between Day 49 and Day 0	No
Secondary	Evolution of Lequesne Algofunctional index score		Between D49 and Day 0	No
Secondary	Responder rate according to OARSI-OMERACT criteria		At Day 49	No