Efficacy of UniRelieverTM Offloading Brace in the Management of Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

— UNIBRACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05905809
• Other study ID #: EC43
• Status: Completed
• Phase: N/A
• Start date: June 7, 2023
• Est. completion date: September 20, 2023

Study information

• Verified date: April 2024
• Source: Thuasne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 20, 2023
• Est. primary completion date: September 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• UniRelieverTM offloading brace (THUASNE)
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
• Unloader One® X brace (Össur)
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

Locations

Country	Name	City	State
Germany	Trauma Orthopedic Surgery Practice Center	Aachen	Friedrich-Wilhelm-Platz 5

Sponsors (2)

Lead Sponsor	Collaborator
Thuasne	MED-RAS GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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