Efficacy of UniRelieverTM Offloading Brace in the Management of Knee Osteoarthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-07

Study Completion Date

2023-09-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

An interventional, prospective, monocentric, randomized, open and controlled study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group I with UniRelieverTM offloading brace

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.

Group Type EXPERIMENTAL

UniRelieverTM offloading brace (THUASNE)

Intervention Type DEVICE

The patient will be instructed to wear the brace during walking and physical exercise. The investigator will explain to the patient how to adjust it

Group II with Unloader One® X brace

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

Group Type EXPERIMENTAL

Unloader One® X brace (Össur)

Intervention Type DEVICE

The patient will be instructed to wear the brace during walking and physical exercise. The investigator will explain to the patient how to adjust it

Group III without orthosis

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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UniRelieverTM offloading brace (THUASNE)

The patient will be instructed to wear the brace during walking and physical exercise. The investigator will explain to the patient how to adjust it

Intervention Type DEVICE

Unloader One® X brace (Össur)

The patient will be instructed to wear the brace during walking and physical exercise. The investigator will explain to the patient how to adjust it

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No