Efficacy of UniRelieverTM Offloading Brace in the Management of Knee Osteoarthritis
- Conditions
- Osteoarthritis, Knee
- Interventions
- Device: UniRelieverTM offloading brace (THUASNE)Device: Unloader One® X brace (Össur)
- Registration Number
- NCT05905809
- Lead Sponsor
- Thuasne
- 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.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group I with UniRelieverTM offloading brace UniRelieverTM offloading brace (THUASNE) 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 II with Unloader One® X brace Unloader One® X brace (Össur) 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
- Primary Outcome Measures
Name Time Method Pain-free walking distance 6 weeks The evolution of pain-free walking distance evaluated by reporting the distance that the patient can walk without pain.
- Secondary Outcome Measures
Name Time Method Knee functional capacity 6 weeks 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)
Assessment of compliance 6 weeks 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.
Pain on loading 6 weeks 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)
Pain at rest 6 weeks 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)
Subjective range of movement 6 weeks The subjective knee range of movement is assessed qualitatively by having patients rate it as follow:
* 'clearly improved',
* 'improved',
* 'unchanged',
* 'deteriorated'
* 'clearly deteriorated'.Analgesic consumption 6 weeks 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 .
Objective range of movement 6 weeks The objective improvement of knee range of movement is assessed quantitatively by a goniometer (range of movement measure expressed in degrees)
Assessment of safety (AE and SAEs) 6 weeks 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 deviceAssessment of Patient's Global Impression of Change (PGI-C) 6 weeks 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
Assessment of patient's satisfaction 6 weeks The evaluation of patient satisfaction with devices is assessed via a self-questionnaire at the end of the study
Trial Locations
- Locations (1)
Trauma Orthopedic Surgery Practice Center
🇩🇪Aachen, Friedrich-Wilhelm-Platz 5, Germany