Efficacy of UniRelieverTM Offloading Brace in the Management of Knee Osteoarthritis (UNIBRACE)

THUASNE

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Device: UniRelieverTM offloading brace (THUASNE); Device: Unloader One® X brace (Össur)

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05905809

EC43

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Group I with UniRelieverTM offloading brace

Experimental group

Description:

Patients wearing the UniRelieverTM offloading brace (THUASNE): For intervention group I, in addition to the usual care described above for the control group, patients will wear the studied UniRelieverTM offloading brace.

Treatment:

Device: UniRelieverTM offloading brace (THUASNE)

Group II with Unloader One® X brace

Experimental group

Description:

Patients wearing the Unloader One® X brace (Össur): For intervention group II, in addition to the usual care described above for the control group, patients will wear the Unloader One® X brace by Össur

Treatment:

Device: Unloader One® X brace (Össur)

Group III without orthosis

No Intervention group

Description:

Patients wearing no orthosis: In the control group, usual care is defined by: * buffer heel and/or * insoles and/or * outer edge raisin and/or * walking stick and/or * physiotherapy and/ or * analgesics oral and local depending on the patient's needs.