Clinical Evaluation of the Levitation Knee Brace

NCT05543486 | Completed

• 1 other identifier: REB20-1106
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoarthritis (OA) is a debilitating disease affecting approximately 1/3 of Canadians over the age of 25. Knee OA typically involves at least 2 of 3 compartments in the knee joint. Conservative treatments include knee braces to manage symptoms and improve joint function. Most knee OA braces are designed to offload one knee compartment, but are not usually indicated for multicompartment knee OA. The Levitation Tri-compartment Offloader (TCO) knee brace stores energy during flexion and provides extension assistance to offload all 3 knee compartments. While there is strong preliminary evidence that the TCO can provide pain relief and improved knee function to users, it is critical to determine whether this brace will have similar benefits for patients with multicompartment knee OA. This pilot randomized control trial evaluates the clinical outcomes of using the TCO in comparison to the current conservative standard of care for knee OA patients.

Conditions

Knee Osteoarthritis

Keywords

Osteoarthritis; Knee; Brace; Pain

Outcome Measures

Primary Outcomes (1)

• VAS pain score - chair rise (3 month)

  Change in VAS pain score from baseline to follow up at 3 months (primary end point). Self-reported knee pain intensity experienced over the last week during rising from a seated position, measured using a 0-100 mm visual analogue scale (VAS), where 0 mm represents no pain and 100 mm represents the worst pain imaginable.

  Change from baseline to 3-month follow up

Secondary Outcomes (14)

• VAS pain score - squatting

  Change from baseline to 6-week and 3-month follow ups

• VAS pain score - stairs

  Change from baseline to 6-week and 3-month follow ups

• VAS pain score - walking on incline

  Change from baseline to 6-week and 3-month follow ups

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Change from baseline to 6-week and 3-month follow ups

• EQ-5D Health-related quality of life score

  Change from baseline to 6-week and 3-month follow ups

Other Outcomes (8)

• Lower Extremity Activity Scale (LEAS) score

  Change from baseline to 6-week and 3-month follow ups

• Pre-intervention expectation

  Baseline

• VAS pain score - associated pain

  Change from baseline to 6-week and 3-month follow ups

Study Arms (3)

Levitation 2 Tri-Compartment Offloader (TCO) knee brace

EXPERIMENTAL

Participants in this group are sized and fitted for a Levitation 2 TCO brace and instructed to wear the brace on their affected limb for a total of 3 or more hours per day for 3 months.

Device: Levitation 2 Tri-Compartment Offloader (TCO) knee brace

Knee sleeve

ACTIVE COMPARATOR

Participants are provided with a off-the-shelf knee sleeve and instructed to wear the sleeve on their affected limb for a total of 3 or more hours per day for 3 months.

Device: Knee sleeve

Standard of Care Self-Management

NO INTERVENTION

Control group practicing conservative self-management of knee osteoarthritis without using a knee device (e.g., hard brace or sleeve) for 3 months.

Interventions

Levitation 2 Tri-Compartment Offloader (TCO) knee brace DEVICE

Spring Loaded Technology Levitation 2 Tri-Compartment Offloader (TCO) brace containing proprietary spring technology providing a knee extension assist.

Levitation 2 Tri-Compartment Offloader (TCO) knee brace

Knee sleeve DEVICE

Neenca soft knee sleeve comprised of elastic air knit fabric with a silicone padded patella inset and flexible stays on the medial and lateral sides.

Knee sleeve

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patellofemoral of combined patellofemoral and tibiofemoral knee osteoarthritis
• Kellgren-Lawrence grade ≥ 2 osteoarthritis (moderate-severe) on weight bearing tunnel view x-ray + skyline
• Experience knee pain that worsens (VAS pain score ≥ 4) with activities such as squatting, rising from seated, and going up and down stairs
• Experience less pain (VAS pain score) in the contralateral knee than in the affected knee during weight-bearing activities
• \< 7 degrees of varus/valgus knee alignment
• Knee flexion/extension range of motion from 5-100 degrees minimum
• Between the ages of 18-80
• Able to hear and understand study information and instructions in English
• Must be able to be fit with a Levitation knee brace

You may not qualify if:

• History of arthroplasty or high tibial osteotomy in the affected limb
• Surgery (excluding arthroscopy) on either lower limb within last 6 months
• Arthroscopic debridement of the affected knee within last 3 months
• Received corticosteroid injections in last 3 months
• Received hyaluronic acid or platelet-rich plasma (PRP) injections in last 6 months
• History of rheumatoid arthritis
• Symptomatic disease of the hip, ankle, or foot
• History of traumatic onset of knee pain
• A major lower limb injury within the past year requiring physiotherapy or surgery
• Previous fracture of the tibia or femur of the affected limb
• History of diabetic neuropathy or peripheral vascular disease
• Parkinson's or neurodegenerative order that may affect balance / ability to ambulate
• Use of a non-study provided knee brace on the affected limb over the study period
• Known allergy or adverse skin reaction to neoprene
• Open skin wounds present on the leg of the affected side

Sponsors & Collaborators

• University of Calgary: lead
• Bone and Joint Health Strategic Clinical Network (BJH SCN): collaborator
• McCaig Institiute of Bone and Joint Health: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Alberta Strategy for Patient Oriented Research Support Unit (AbSPORU): collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

Related Publications (17)

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  PMID: 26442224 BACKGROUND

• Sharif B, Kopec J, Bansback N, Rahman MM, Flanagan WM, Wong H, Fines P, Anis A. Projecting the direct cost burden of osteoarthritis in Canada using a microsimulation model. Osteoarthritis Cartilage. 2015 Oct;23(10):1654-63. doi: 10.1016/j.joca.2015.05.029. Epub 2015 Jun 5.

  PMID: 26050868 BACKGROUND

• Carr AJ, Robertsson O, Graves S, Price AJ, Arden NK, Judge A, Beard DJ. Knee replacement. Lancet. 2012 Apr 7;379(9823):1331-40. doi: 10.1016/S0140-6736(11)60752-6. Epub 2012 Mar 6.

  PMID: 22398175 BACKGROUND

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  PMID: 16093843 BACKGROUND

• Heekin RD, Fokin AA. Incidence of bicompartmental osteoarthritis in patients undergoing total and unicompartmental knee arthroplasty: is the time ripe for a less radical treatment? J Knee Surg. 2014 Feb;27(1):77-81. doi: 10.1055/s-0033-1349401. Epub 2013 Jul 19.

  PMID: 23873317 BACKGROUND

• Budarick AR, MacKeil BE, Fitzgerald S, Cowper-Smith CD. Design Evaluation of a Novel Multicompartment Unloader Knee Brace. J Biomech Eng. 2020 Jan 1;142(1):014502. doi: 10.1115/1.4044818.

  PMID: 31523751 BACKGROUND

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  PMID: 10225800 BACKGROUND

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  PMID: 15208174 BACKGROUND

• KELLGREN JH, LAWRENCE JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957 Dec;16(4):494-502. doi: 10.1136/ard.16.4.494. No abstract available.

  PMID: 13498604 BACKGROUND

• Murphy L, Schwartz TA, Helmick CG, Renner JB, Tudor G, Koch G, Dragomir A, Kalsbeek WD, Luta G, Jordan JM. Lifetime risk of symptomatic knee osteoarthritis. Arthritis Rheum. 2008 Sep 15;59(9):1207-13. doi: 10.1002/art.24021.

  PMID: 18759314 BACKGROUND

• Suri P, Morgenroth DC, Hunter DJ. Epidemiology of osteoarthritis and associated comorbidities. PM R. 2012 May;4(5 Suppl):S10-9. doi: 10.1016/j.pmrj.2012.01.007.

  PMID: 22632687 BACKGROUND

• Cherian JJ, Bhave A, Kapadia BH, Starr R, McElroy MJ, Mont MA. Strength and Functional Improvement Using Pneumatic Brace with Extension Assist for End-Stage Knee Osteoarthritis: A Prospective, Randomized trial. J Arthroplasty. 2015 May;30(5):747-53. doi: 10.1016/j.arth.2014.11.036. Epub 2014 Nov 29.

  PMID: 25499679 BACKGROUND

• Dobson F, Hinman RS, Roos EM, Abbott JH, Stratford P, Davis AM, Buchbinder R, Snyder-Mackler L, Henrotin Y, Thumboo J, Hansen P, Bennell KL. OARSI recommended performance-based tests to assess physical function in people diagnosed with hip or knee osteoarthritis. Osteoarthritis Cartilage. 2013 Aug;21(8):1042-52. doi: 10.1016/j.joca.2013.05.002. Epub 2013 May 13.

  PMID: 23680877 BACKGROUND

• Deshpande BR, Katz JN, Solomon DH, Yelin EH, Hunter DJ, Messier SP, Suter LG, Losina E. Number of Persons With Symptomatic Knee Osteoarthritis in the US: Impact of Race and Ethnicity, Age, Sex, and Obesity. Arthritis Care Res (Hoboken). 2016 Dec;68(12):1743-1750. doi: 10.1002/acr.22897. Epub 2016 Nov 3.

  PMID: 27014966 BACKGROUND

• Bombardier C, Hawker GA, Mosher D. The impact of arthritis in Canada: Today and over the next 30 years. Arthritis Alliance of Canda, 2011. https://www.arthritisalliance.ca/images/PDF/eng/Initiatives/20111022_2200_impact_of_arthritis.pdf

  BACKGROUND

• McGibbon CA, Mohamed A. Knee load reduction from an energy storing mechanical brace: a simulation study. 20th Biennial meeting, Canadian Society of Biomechanics, Halifax, Canada, Aug 2018.

  BACKGROUND

• Bishop EL, Bonhomme J, Joffe M, Cowper-Smith C, Ronsky JL, Clark ML. A feasibility randomised trial evaluating the levitation tri-compartment offloader knee brace for multicompartment knee osteoarthritis. Pilot Feasibility Stud. 2025 Jun 13;11(1):81. doi: 10.1186/s40814-025-01660-2.

  PMID: 40514746 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Janet L Ronsky, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes are assessed by a blinded examiner
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, parallel arm

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 16, 2022
• Study Start: August 19, 2021
• Primary Completion: September 29, 2022
• Study Completion: September 30, 2022
• Last Updated: March 30, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)