Efficacy of UniRelieverTM Offloading Brace in the Management of Knee Osteoarthritis

Controlled, Randomized, Open Label Study to Assess the Efficacy of UniRelieverTM Offloading Brace in the Management of Knee Osteoarthritis

The objective of this study is to assess the efficacy and performance of a new semi-rigid offloading brace in the management of knee osteoarthritis.

Osteoarthritis (OA) is one of the leading causes of physical disability in the world, affecting a growing portion of the elderly, indeed, it is estimated that 85% of all people over age 60 have some degree of OA.

A survey of 2000 French general practitioners indicated that 10% usually prescribe knee orthoses for patients with knee OA. With the increasing importance of non-pharmacological treatment in recommendations for OA, orthoses will increase in use.

The use of an offloading knee brace that encompasses the knee has proven to be a safe, cost-efficient treatment option for reducing pain and improving function. It can even delay the need for surgery.

The aim of this study is to perform a randomized, prospective, interventional, 3-arm parallel group study to look at the difference in outcome in knee osteoarthritic patient with the use of the new semi-rigid offloading brace versus knee brace comparator versus without orthosis.

Inclusion Criteria:

• Age ≥ 18 years
• Medial femorotibial knee osteoarthritis grade 2, 3 or 4 according to the Kellgren Lawrence system
• Visual Analog Scale pain ≥ 40/100 in the last 48 hours
• Signed informed consent prior to any study-mandated procedure.
• Affiliated to the General regime of the Social Security or covered by a similar health insurance system

Exclusion Criteria:

• Inability to walk or dependance on a wheelchair or use of crutches.
• Diseases that do not allow participation in the study for a period of six weeks.
• Concomitant ipsilateral patellofemoral osteoarthritis associated with a more severe pain than the one for medial OA.
• Ipsilateral osteoarthritis of the hip associated with a more severe pain than the one for medial OA.
• A body mass index over 35.
• Successful Cortisone injection within the last four weeks before the start of the study.
• Participation to any other clinical study which has an impact on the different endpoints.
• Vulnerable patient, adults being the object of a legal protective measure or enable to express their consent.
• Inability to communicate in German.