Efficacy of UniRelieverTM Offloading Brace in the Management of Knee Osteoarthritis

NCT05905809 | Completed

• 1 other identifier: EC43
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis; Knee Brace; Knee functional capacity; Pain; Compliance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Knee functional capacity

  6 weeks

• Pain on loading

  6 weeks

• Pain at rest

  6 weeks

• Analgesic consumption

  6 weeks

• Subjective range of movement

  6 weeks

Study Arms (3)

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.

Device: UniRelieverTM offloading brace (THUASNE)

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

Device: Unloader One® X brace (Össur)

Group III without orthosis

NO INTERVENTION

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.

Interventions

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

Group I with UniRelieverTM offloading brace

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

Group II with Unloader One® X brace

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thuasne: lead
• MED-RAS GmbH: collaborator

Study Sites (1)

Trauma Orthopedic Surgery Practice Center

Aachen, Friedrich-Wilhelm-Platz 5, 52062, Germany

Location

Related Publications (9)

• 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.

  PMID: 27939833 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.

  PMID: 29736571 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.

  PMID: 30243296 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.

  PMID: 25160784 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.

  PMID: 31168421 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.

  PMID: 30255369 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.

  PMID: 15094138 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.

  PMID: 21273902 BACKGROUND

• 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.

  PMID: 41331771 DERIVED

Related Links

• COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Pain; Patient Compliance

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Michael Benning, MD

  Trauma Orthopedic Surgery Practice Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: An interventional, prospective, monocentric, randomized, open and controlled study

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 15, 2023
• Study Start: June 7, 2023
• Primary Completion: September 20, 2023
• Study Completion: September 20, 2023
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)