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| Name | Class |
|---|---|
| MED-RAS GmbH | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I with UniRelieverTM offloading brace | Experimental | 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 | Experimental | 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 III without orthosis | No Intervention | Patients wearing no orthosis: In the control group, usual care is defined by:
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UniRelieverTM offloading brace (THUASNE) | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Benning, MD | Trauma Orthopedic Surgery Practice Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trauma Orthopedic Surgery Practice Center | Aachen | Friedrich-Wilhelm-Platz 5 | 52062 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27939833 | Background | Beaudreuil J. Orthoses for osteoarthritis: A narrative review. Ann Phys Rehabil Med. 2017 Apr;60(2):102-106. doi: 10.1016/j.rehab.2016.10.005. Epub 2016 Dec 6. | |
| 29736571 | Background | Grazina R, Andrade R, Bastos R, Costa D, Pereira R, Marinhas J, Maestro A, Espregueira-Mendes J. Clinical Management in Early OA. Adv Exp Med Biol. 2018;1059:111-135. doi: 10.1007/978-3-319-76735-2_5. |
| Label | URL |
|---|---|
| COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) | View source |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| D010146 | Pain |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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An interventional, prospective, monocentric, randomized, open and controlled study
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| Unloader One® X brace (Össur) | 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 |
|
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:
| 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:
| 6 weeks |
| 30243296 | Background | Hjartarson HF, Toksvig-Larsen S. The clinical effect of an unloader brace on patients with osteoarthritis of the knee, a randomized placebo controlled trial with one year follow up. BMC Musculoskelet Disord. 2018 Sep 22;19(1):341. doi: 10.1186/s12891-018-2256-7. |
| 25160784 | Background | Maleki M, Arazpour M, Joghtaei M, Hutchins SW, Aboutorabi A, Pouyan A. The effect of knee orthoses on gait parameters in medial knee compartment osteoarthritis: A literature review. Prosthet Orthot Int. 2016 Apr;40(2):193-201. doi: 10.1177/0309364614547411. Epub 2014 Aug 26. |
| 31168421 | Background | Parween R, Shriram D, Mohan RE, Lee YHD, Subburaj K. Methods for evaluating effects of unloader knee braces on joint health: a review. Biomed Eng Lett. 2019 Jan 23;9(2):153-168. doi: 10.1007/s13534-019-00094-z. eCollection 2019 May. |
| 30255369 | Background | Petersen W, Ellermann A, Henning J, Nehrer S, Rembitzki IV, Fritz J, Becher C, Albasini A, Zinser W, Laute V, Ruhnau K, Stinus H, Liebau C. Non-operative treatment of unicompartmental osteoarthritis of the knee: a prospective randomized trial with two different braces-ankle-foot orthosis versus knee unloader brace. Arch Orthop Trauma Surg. 2019 Feb;139(2):155-166. doi: 10.1007/s00402-018-3040-8. Epub 2018 Sep 25. |
| 15094138 | Background | Pham T, van der Heijde D, Altman RD, Anderson JJ, Bellamy N, Hochberg M, Simon L, Strand V, Woodworth T, Dougados M. OMERACT-OARSI initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited. Osteoarthritis Cartilage. 2004 May;12(5):389-99. doi: 10.1016/j.joca.2004.02.001. |
| 21273902 | Background | Raja K, Dewan N. Efficacy of knee braces and foot orthoses in conservative management of knee osteoarthritis: a systematic review. Am J Phys Med Rehabil. 2011 Mar;90(3):247-62. doi: 10.1097/PHM.0b013e318206386b. |
| 41331771 | Derived | Benning M, Villet S, Marques A, Hilgers RD. The effectiveness of the UniReliever offloading knee brace for treating medial knee osteoarthritis: A randomized clinical trial. Prosthet Orthot Int. 2025 Dec 3. doi: 10.1097/PXR.0000000000000503. Online ahead of print. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |