Efficacy of UniRelieverTM Offloading Brace in the Management of Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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 (Parween et al. 2019). 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 (Beaudreuil 2017). 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.

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

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Device: UniRelieverTM offloading brace (THUASNE)
* Device: Unloader One® X brace (Össur)


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: An interventional, prospective, monocentric, randomized, open and controlled study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br>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. | Device: UniRelieverTM offloading brace (THUASNE)<br>* 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<br>|
| Experimental: Group II<br>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 | Device: Unloader One® X brace (Össur)<br>* 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<br>|
| No Intervention: Group III<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain-free walking distance | The evolution of pain-free walking distance evaluated by reporting the distance that the patient can walk without pain. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee functional capacity | The evolution of knee functional capacity is evaluated by the Lequesne index completed by the patient at inclusion and six weeks of follow-up (minimum index score 0: None handicap, maximum index score 24: Handicap extremely severe) | 6 weeks | 
| Pain on loading | The evolution of pain on loading is measured via a numerical rating scale (NRS) after a thirty-minute walk at inclusion and six weeks of follow-up: 0 corresponds to no pain (better outcome) and 10 to maximum pain (worst outcome) | 6 weeks | 
| Pain at rest | The evolution of pain at rest is measured via a numerical rating scale (NRS) at inclusion and six weeks of follow-up: 0 corresponds to no pain (better outcome) and 10 to maximum pain (worst outcome) | 6 weeks | 
| Analgesic consumption | The use of analgesics is collected all along the study via a patient's diary completed by the patient every day and via the physician during the inclusion and the six weeks follow-up visit . | 6 weeks | 
| Subjective range of movement | The subjective knee range of movement is assessed qualitatively by having patients rate it as follow: 'clearly improved', 'improved', 'unchanged', 'deteriorated' 'clearly deteriorated'. | 6 weeks | 
| Objective range of movement | The objective improvement of knee range of movement is assessed quantitatively by a goniometer (range of movement measure expressed in degrees) | 6 weeks | 
| Assessment of Patient's Global Impression of Change (PGI-C) | Patient's opinion on Global Impression of Change about his/her general condition by using the PGIC questionnaire completed at the six weeks follow-up visit by the patient. The scale has 7 levels from no change or condition has got worsed(worse outcome) to a great deal better, and a considerable improvement that has made all the difference (better outcome). Intermediate levels are: almost the same, hardly any change at all; a little better, but no noticeable change, somewhat better, but the change has not made any real difference; moderately better, and a slight but noticeable change; better, and a definite improvement that has made a real and worthwhile difference | 6 weeks | 
| Assessment of compliance | The evaluation of compliance with devices during the duration of the study is reported by the investigator according to the patient's diary completed by the patient each day. | 6 weeks | 
| Assessment of patient's satisfaction | The evaluation of patient satisfaction with devices is assessed via a self-questionnaire at the end of the study | 6 weeks | 
| Assessment of safety (AE and SAEs) | The safety of the devices is evaluated by the description of Adverse Events (AEs) and Serious Adverse Events (SAEs) occurring during the study and collected by the patient via the patient's diary and the investigator during follow-up visits: number, type, frequency, intensity, relationship with the study device | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, Knee Brace, Knee functional capacity, Pain, Compliance