Clinical trial NCT05905809: Efficacy of UniRelieverTM Offloading Brace in the Management of Knee Osteoarthritis
Official title: Controlled, Randomized, Open Label Study to Assess the Efficacy of UniRelieverTM Offloading Brace in the Management of Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis
Knee Brace
Knee functional capacity
Pain
Compliance
Lead sponsor: Thuasne
Sponsor class: INDUSTRY
Collaborators: name: MED-RAS GmbH
First posted: 2023-06-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An interventional, prospective, monocentric, randomized, open and controlled study
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain-free walking distance
timeFrame: 6 weeks
Secondary outcomes:
measure: Knee functional capacity
timeFrame: 6 weeks
measure: Pain on loading
timeFrame: 6 weeks
measure: Pain at rest
timeFrame: 6 weeks
measure: Analgesic consumption
timeFrame: 6 weeks
measure: Subjective range of movement
timeFrame: 6 weeks
measure: Objective range of movement
timeFrame: 6 weeks
measure: Assessment of Patient's Global Impression of Change (PGI-C)
timeFrame: 6 weeks
measure: Assessment of compliance
timeFrame: 6 weeks
measure: Assessment of patient's satisfaction
timeFrame: 6 weeks
measure: Assessment of safety (AE and SAEs)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Trauma Orthopedic Surgery Practice Center
state: Friedrich-Wilhelm-Platz 5
Study officials:
affiliation: Trauma Orthopedic Surgery Practice Center
name: Michael Benning, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.