Knee OsteoarthritisNCT05543486
Clinical Evaluation of the Levitation Knee Brace
A study testing Levitation 2 Tri-Compartment Offloader (TCO) knee brace and Knee sleeve in people with Knee Osteoarthritis, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Levitation 2 Tri-Compartment Offloader (TCO) knee brace and Knee sleeve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 19 Aug 2021to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
- Unable to physically or mentally comply with the wearing of a knee brace
- Any contraindications for knee bracing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Levitation Knee Brace in Patients With Knee Osteoarthritis: A Pilot Study
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.
Read the detailed description
Osteoarthritis (OA) is a debilitating musculoskeletal disease affecting approximately 1/3 of Canadians over age 25. The disease is characterized by loss of cartilage in the afflicted joint and can be a major source of pain, disability, and reduced quality of life. The direct cost of OA in Canada was $2.9 billion CAD in 2010 and is expected to rise to $7.6 billion CAD by 2031. Total knee replacement (TKR) is often used to restore mobility, and the risk for expensive and invasive revision surgery is 2-5 times higher in OA patients younger than 65 years. Thus, finding an alternate early treatment intervention is imperative for societal and economic health. It is well established that excess joint loading is associated with symptoms of knee pain. Existing knee OA (KOA) braces are designed to unload part of the joint to help reduce symptoms of pain and enable patients to participate in physical activity. However, because the majority of KOA braces are designed to offload only one tibiofemoral compartment, they are not indicated for most patients who suffer from patellofemoral (PF) or multi-compartment KOA. The Levitation "Tri-Compartment Offloader" (TCO) knee brace developed by Spring Loaded Technology (SLT) was designed to reduce KOA pain by decreasing compressive forces in all three compartments of the knee with a silicone "liquid spring" providing knee extension assist. The design is predicted to lower the tensile forces of the quadriceps pulling on the knee, thereby decreasing internal joint forces in all three knee compartments. Survey evidence suggests the TCO provides pain relief and improved function to long-term wearers with KOA, especially those with involvement of the PF compartment. However, the generalizability of these benefits to a larger group needs to be investigated through a controlled clinical study involving patients with PF or multi-compartment KOA. The TCO brace provides both a proprioceptive effect as well as a mechanical effect. Soft-shell neoprene knee braces (or 'sleeves') have been shown to reduce pain in KOA patients, believed to be a result of improved proprioception. In order to better isolate and understand the mechanical effect of the extension assist mechanism of the TCO brace on patient outcomes, we require an intervention group with a proprioception intervention only, such as a neoprene sleeve, to remove the potentially confounding effect of proprioception on measured outcomes. Preliminary clinical trial priorities, design and outcome measures have been developed based on clinical outcomes of interest relating to KOA. Participation from key stakeholders including patients, healthcare providers, healthcare administrators and brace manufacturers is critical to ensure research priorities and outcomes are relevant and meaningful. This study represents an opportunity to work directly with patients in the research process, and to evaluate the outcomes of adopting a patient-oriented research approach. Therefore, the focus of this project is to (1) strengthen our preliminary clinical trial plan by refining the priorities, design and desired outcomes, and (2) complete and evaluate a pilot clinical trial based on patient and knowledge-user participation in all phases of the project.
The overall research goal is to conduct a clinical evaluation of the TCO knee brace for treating PF or multi-compartment KOA while incorporating patient participation for optimized study design, implementation and analysis of key outcome measures. This goal will be accomplished across 3 objectives (OB) that coincide with 3 distinct project phases, whereby each project phase is dependent on the outcomes of the previous project phases.
Phase 1 (OB1): Review and improve clinical trial objectives, design and methodology.
Phase 2 (OB2): Perform a pilot trial to evaluate the TCO knee brace in 30 study participants.
Phase 3 (OB3): Interpret study results and create a knowledge translation (KT) plan.
A fourth study objective (OB4) is to evaluate the impact of patient and researcher engagement on the study. This objective will be addressed throughout the duration of the study.
Study Milestones (Specific Aims - SA relating to Objectives).
SA1.1 Recruit patient partners to form the Patient Advisory Committee (PAC).
SA1.2 Plan and conduct a focus group to review clinical trial design and methodology.
SA1.3 Summarize and incorporate patient and researcher feedback into the clinical trial design.
SA2.1 Recruit pilot study participants and assign into an intervention group.
SA2.2 Collect baseline data and 3-month intervention data.
SA2.3 Perform statistical data analysis.
SA3.1 Plan and conduct a focus group to review study results and solicit ideas for dissemination.
SA3.2 Incorporate feedback into interpretation of pilot trial results.
SA3.3 Create and implement knowledge dissemination plan.
SA4.1 Create framework to evaluate patient and researcher engagement.
SA4.2 Implement evaluation tool to evaluate patient and researcher engagement.
SA4.3 Analyze and summarize results of engagement evaluation.
KOA affects over 14 million individuals in North America. In Canada, the economic burden of OA cost the healthcare system approximately $27.5B in 2010. A significant portion of the economic burden is related to indirect costs from loss of employment, tax dollars, and disability compensation. This is largely driven by a lack of appropriate solutions for KOA patients to maintain independence and mobility. The Levitation TCO knee brace represents a promising new technology for reducing pain and maintaining mobility in patients who have, or are developing KOA. Generating scientific evidence on the effectiveness of the TCO brace will allow patients and healthcare providers to make informed decisions regarding their treatment options for KOA. Involving patients directly in the study design, conduct, interpretation and dissemination activities will increase the relevance and utility of results and the overall impact. If proven effective, this solution will allow patients to continue working and living the lifestyle they enjoy for much longer than they would otherwise. Given the high prevalence of KOA, the TCO brace has the potential to significantly improve quality of life for millions of Canadians, while significantly reducing the economic burden of KOA in Canada and beyond.
- Conditions
- Knee Osteoarthritis
- Being tested
- Levitation 2 Tri-Compartment Offloader (TCO) knee brace, Knee sleeve
- Keywords
- Osteoarthritis, Knee, Brace, Pain
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levitation 2 Tri-Compartment Offloader (TCO) knee braceDevice
Spring Loaded Technology Levitation 2 Tri-Compartment Offloader (TCO) brace containing proprietary spring technology providing a knee extension assist.
Knee sleeveDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 3-month follow up
Secondary outcomes (14)
VAS pain score - squatting
Change in VAS pain score from baseline to follow ups at 6 weeks and 3 months.
Self-reported knee pain intensity experienced over the last week during squatting, measured using a 0-100 mm visual analogue scale (VAS), where 0 mm represents no pain and 100 mm represents the worst pain imaginable.
Measured: Change from baseline to 6-week and 3-month follow ups
VAS pain score - stairs
Change in VAS pain score from baseline to follow ups at 6 weeks and 3 months.
Self-reported knee pain intensity experienced over the last week during stairs, measured using a 0-100 mm visual analogue scale (VAS), where 0 mm represents no pain and 100 mm represents the worst pain imaginable.
Measured: Change from baseline to 6-week and 3-month follow ups
VAS pain score - walking on incline
Change in VAS pain score from baseline to follow ups at 6 weeks and 3 months.
Self-reported knee pain intensity experienced over the last week during walking on an incline, measured using a 0-100 mm visual analogue scale (VAS), where 0 mm represents no pain and 100 mm represents the worst pain imaginable.
Measured: Change from baseline to 6-week and 3-month follow ups
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Change in KOOS from baseline to follow ups at 6 weeks and 3 months.
Knee Injury and Osteoarthritis Outcome Score (KOOS) encompasses 42-tiems (question) across 5 sub-scales: Pain (9 items); Symptoms (7 items); Activities of Daily Living Function (17 items); Sport and Recreation Function (5 items); Quality of Life (4 items). Each item uses a Likert scale with five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems). Each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
Measured: Change from baseline to 6-week and 3-month follow ups
EQ-5D Health-related quality of life score
Change in EQ-5D health-related quality of life score from baseline to follow ups at 6 weeks and 3 months.
Health related quality of life score is collected using the 5-item descriptive system of the EQ-5D questionnaire covering five dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The level (score) for the five dimensions is combined into a 5-digit number that describes the patient's health state.
Measured: Change from baseline to 6-week and 3-month follow ups
30 second chair stand test
Change in 30 second chair stand test score from baseline to follow up at 3 months.
The maximum number of sit to stand repetitions from a stationary chair (seat height = 44 cm) that can be completed in 30 seconds.
Measured: Change from baseline to 3-month follow up
40m fast-paced walk test
Change in 40m fast-paced walk test score from baseline to follow up at 3 months.
The amount of time in seconds it taken to walk a 40 meters along a 10 meter long gait platform, moving as quickly as without running.
Measured: Change from baseline to 3-month follow up
Stair climb test
Change in stair climb test score from baseline to follow up at 3 months.
The amount of time in seconds to ascend and immediately descend a 5-step staircase (step height = 19 cm) as quickly as possible without running or skipping steps.
Measured: Change from baseline to 3-month follow up
Timed up and go test
Change in stair climb test score from baseline to follow up at 3 months.
The amount of time in seconds taken to rise from a stationary chair, walk 3 meters forward, turn, walk 3 meters back to the chair, and sit back down in the chair, moving as quickly as possible without running.
Measured: Change from baseline to 3-month follow up
6 minute walk test
Change in 6 minute walk test score from baseline to follow up at 3 months.
The maximum amount of distance in meters that can be walked in 6 minutes along a 10 meter gait platform, moving as quickly as possible without running.
Measured: Change from baseline to 3-month follow up
Quadriceps strength
Change in quadriceps strength from baseline to follow up at 3 months.
Quadriceps strength refers to maximal voluntary isometric contraction the quadriceps muscles at 45 degrees of knee bend measured in Newton meters (Nm) using a Biodex Medical Systems dynamometer. Quadriceps strength score is recorded as average peak torque in Nm across 3 maximal quadriceps contractions lasting 3 seconds with a 1 minute rest between contractions.
Measured: Change from baseline to 3-month follow up
Hamstrings strength
Change in hamstrings strength from baseline to follow up at 3 months.
Hamstrings strength refers to the maximal voluntary isometric contraction of the hamstrings muscles at 15 degrees of knee bend measured as peak torque in Newton meters (Nm) using a Biodex Medical Systems dynamometer. Hamstrings strength score is recorded as average peak torque in Nm across 3 maximal hamstrings contractions lasting 3 seconds with a 1 minute rest between contractions.
Measured: Change from baseline to 3-month follow up
EQ-VAS
Change in EQ-VAS score from baseline to follow ups at 6 weeks and 3 months.
The EQ VAS records self-rated health on a 0-100 vertical visual analogue scale (VAS), where 0 is labelled as "The worst health you can imagine" and 100 is labelled as "The best health you can imagine."
Measured: Change from baseline to 6-week and 3-month follow ups
VAS pain score - chair rise (6 week)
Change in VAS pain score from baseline to follow up at 6 weeks.
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.
Measured: Change from baseline to 6-week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start19 Aug 2021
- Primary completion29 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, parallel arm
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Bone and Joint Health Strategic Clinical Network (BJH SCN), McCaig Institiute of Bone and Joint Health, Canadian Institutes of Health Research (CIHR), Alberta Strategy for Patient Oriented Research Support Unit (AbSPORU)
- Responsible party
- Sponsor
- Investigators
- Janet L Ronsky, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543486
- Sponsor's protocol ID
- REB20-1106
- Status last verified
- Jan 2024
- First submitted
- 6 Sep 2022
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Birtwhistle R, Morkem R, Peat G, Williamson T, Green ME, Khan S, Jordan KP. Prevalence and management of osteoarthritis in primary care: an epidemiologic cohort study from the Canadian Primary Care Sentinel Surveillance Network. CMAJ Open. 2015 Jul 17;3(3):E270-5. doi: 10.9778/cmajo.20150018. eCollection 2015 Jul-Sep.
PubMed 26442224Sharif 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.
PubMed 26050868Carr 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.
PubMed 22398175Felson DT. The sources of pain in knee osteoarthritis. Curr Opin Rheumatol. 2005 Sep;17(5):624-8. doi: 10.1097/01.bor.0000172800.49120.97.
PubMed 16093843Heekin 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.
PubMed 23873317Budarick 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.
PubMed 31523751Kirkley A, Webster-Bogaert S, Litchfield R, Amendola A, MacDonald S, McCalden R, Fowler P. The effect of bracing on varus gonarthrosis. J Bone Joint Surg Am. 1999 Apr;81(4):539-48. doi: 10.2106/00004623-199904000-00012.
PubMed 10225800Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, Bombardier C, Felson D, Hochberg M, van der Heijde D, Dougados M. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis. 2005 Jan;64(1):29-33. doi: 10.1136/ard.2004.022905. Epub 2004 Jun 18.
PubMed 15208174KELLGREN 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.
PubMed 13498604Murphy 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.
PubMed 18759314Suri 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.
PubMed 22632687Cherian 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.
PubMed 25499679Dobson 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.
PubMed 23680877Deshpande 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.
PubMed 27014966Bombardier 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Levitation Knee Brace in Patients With Knee Osteoarthritis: A Pilot Study
- ClinicalTrials.gov ID
- NCT05543486
- Acronym / sponsor ID
- REB20-1106
- Conditions
- Knee Osteoarthritis
- Keywords
- Osteoarthritis, Knee, Brace, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Bone and Joint Health Strategic Clinical Network (BJH SCN), McCaig Institiute of Bone and Joint Health, Canadian Institutes of Health Research (CIHR), Alberta Strategy for Patient Oriented Research Support Unit (AbSPORU)
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 29 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Osteoarthritis (OA) is a debilitating musculoskeletal disease affecting approximately 1/3 of Canadians over age 25. The disease is characterized by loss of cartilage in the afflicted joint and can be a major source of pain, disability, and reduced quality of life. The direct cost of OA in Canada was $2.9 billion CAD in 2010 and is expected to rise to $7.6 billion CAD by 2031. Total knee replacement (TKR) is often used to restore mobility, and the risk for expensive and invasive revision surgery is 2-5 times higher in OA patients younger than 65 years. Thus, finding an alternate early treatment intervention is imperative for societal and economic health. It is well established that excess joint loading is associated with symptoms of knee pain. Existing knee OA (KOA) braces are designed to unload part of the joint to help reduce symptoms of pain and enable patients to participate in physical activity. However, because the majority of KOA braces are designed to offload only one tibiofemoral compartment, they are not indicated for most patients who suffer from patellofemoral (PF) or multi-compartment KOA. The Levitation "Tri-Compartment Offloader" (TCO) knee brace developed by Spring Loaded Technology (SLT) was designed to reduce KOA pain by decreasing compressive forces in all three compartments of the knee with a silicone "liquid spring" providing knee extension assist. The design is predicted to lower the tensile forces of the quadriceps pulling on the knee, thereby decreasing internal joint forces in all three knee compartments. Survey evidence suggests the TCO provides pain relief and improved function to long-term wearers with KOA, especially those with involvement of the PF compartment. However, the generalizability of these benefits to a larger group needs to be investigated through a controlled clinical study involving patients with PF or multi-compartment KOA. The TCO brace provides both a proprioceptive effect as well as a mechanical effect. Soft-shell neoprene knee braces (or 'sleeves') have been shown to reduce pain in KOA patients, believed to be a result of improved proprioception. In order to better isolate and understand the mechanical effect of the extension assist mechanism of the TCO brace on patient outcomes, we require an intervention group with a proprioception intervention only, such as a neoprene sleeve, to remove the potentially confounding effect of proprioception on measured outcomes. Preliminary clinical trial priorities, design and outcome measures have been developed based on clinical outcomes of interest relating to KOA. Participation from key stakeholders including patients, healthcare providers, healthcare administrators and brace manufacturers is critical to ensure research priorities and outcomes are relevant and meaningful. This study represents an opportunity to work directly with patients in the research process, and to evaluate the outcomes of adopting a patient-oriented research approach. Therefore, the focus of this project is to (1) strengthen our preliminary clinical trial plan by refining the priorities, design and desired outcomes, and (2) complete and evaluate a pilot clinical trial based on patient and knowledge-user participation in all phases of the project.
The overall research goal is to conduct a clinical evaluation of the TCO knee brace for treating PF or multi-compartment KOA while incorporating patient participation for optimized study design, implementation and analysis of key outcome measures. This goal will be accomplished across 3 objectives (OB) that coincide with 3 distinct project phases, whereby each project phase is dependent on the outcomes of the previous project phases.
Phase 1 (OB1): Review and improve clinical trial objectives, design and methodology.
Phase 2 (OB2): Perform a pilot trial to evaluate the TCO knee brace in 30 study participants.
Phase 3 (OB3): Interpret study results and create a knowledge translation (KT) plan.
A fourth study objective (OB4) is to evaluate the impact of patient and researcher engagement on the study. This objective will be addressed throughout the duration of the study.
Study Milestones (Specific Aims - SA relating to Objectives).
SA1.1 Recruit patient partners to form the Patient Advisory Committee (PAC).
SA1.2 Plan and conduct a focus group to review clinical trial design and methodology.
SA1.3 Summarize and incorporate patient and researcher feedback into the clinical trial design.
SA2.1 Recruit pilot study participants and assign into an intervention group.
SA2.2 Collect baseline data and 3-month intervention data.
SA2.3 Perform statistical data analysis.
SA3.1 Plan and conduct a focus group to review study results and solicit ideas for dissemination.
SA3.2 Incorporate feedback into interpretation of pilot trial results.
SA3.3 Create and implement knowledge dissemination plan.
SA4.1 Create framework to evaluate patient and researcher engagement.
SA4.2 Implement evaluation tool to evaluate patient and researcher engagement.
SA4.3 Analyze and summarize results of engagement evaluation.
KOA affects over 14 million individuals in North America. In Canada, the economic burden of OA cost the healthcare system approximately $27.5B in 2010. A significant portion of the economic burden is related to indirect costs from loss of employment, tax dollars, and disability compensation. This is largely driven by a lack of appropriate solutions for KOA patients to maintain independence and mobility. The Levitation TCO knee brace represents a promising new technology for reducing pain and maintaining mobility in patients who have, or are developing KOA. Generating scientific evidence on the effectiveness of the TCO brace will allow patients and healthcare providers to make informed decisions regarding their treatment options for KOA. Involving patients directly in the study design, conduct, interpretation and dissemination activities will increase the relevance and utility of results and the overall impact. If proven effective, this solution will allow patients to continue working and living the lifestyle they enjoy for much longer than they would otherwise. Given the high prevalence of KOA, the TCO brace has the potential to significantly improve quality of life for millions of Canadians, while significantly reducing the economic burden of KOA in Canada and beyond.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective, randomized, parallel arm
| Arm | Type | Receives |
|---|---|---|
| Levitation 2 Tri-Compartment Offloader (TCO) knee brace | Experimental | Device: Levitation 2 Tri-Compartment Offloader (TCO) knee braceParticipants 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. |
| Knee sleeve | Active comparator | Device: Knee sleeveParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levitation 2 Tri-Compartment Offloader (TCO) knee braceSpring Loaded Technology Levitation 2 Tri-Compartment Offloader (TCO) brace containing proprietary spring technology providing a knee extension assist. | Device | Levitation 2 Tri-Compartment Offloader (TCO) knee brace |
| Knee sleeveNeenca soft knee sleeve comprised of elastic air knit fabric with a silicone padded patella inset and flexible stays on the medial and lateral sides. | Device | Knee sleeve |
Primary outcome
VAS pain score - chair rise (3 month)
Time frame: Change from baseline to 3-month follow up
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.
14 secondary outcomes
VAS pain score - squatting
Time frame: Change from baseline to 6-week and 3-month follow ups
VAS pain score - stairs
Time frame: Change from baseline to 6-week and 3-month follow ups
VAS pain score - walking on incline
Time frame: Change from baseline to 6-week and 3-month follow ups
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Change from baseline to 6-week and 3-month follow ups
EQ-5D Health-related quality of life score
Time frame: Change from baseline to 6-week and 3-month follow ups
30 second chair stand test
Time frame: Change from baseline to 3-month follow up
40m fast-paced walk test
Time frame: Change from baseline to 3-month follow up
Stair climb test
Time frame: Change from baseline to 3-month follow up
Timed up and go test
Time frame: Change from baseline to 3-month follow up
6 minute walk test
Time frame: Change from baseline to 3-month follow up
Quadriceps strength
Time frame: Change from baseline to 3-month follow up
Hamstrings strength
Time frame: Change from baseline to 3-month follow up
EQ-VAS
Time frame: Change from baseline to 6-week and 3-month follow ups
VAS pain score - chair rise (6 week)
Time frame: Change from baseline to 6-week follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Background: PubMed 26442224Birtwhistle R, Morkem R, Peat G, Williamson T, Green ME, Khan S, Jordan KP. Prevalence and management of osteoarthritis in primary care: an epidemiologic cohort study from the Canadian Primary Care Sentinel Surveillance Network. CMAJ Open. 2015 Jul 17;3(3):E270-5. doi: 10.9778/cmajo.20150018. eCollection 2015 Jul-Sep.
- Background: PubMed 26050868Sharif 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.
- Background: PubMed 22398175Carr 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.
- Background: PubMed 16093843Felson DT. The sources of pain in knee osteoarthritis. Curr Opin Rheumatol. 2005 Sep;17(5):624-8. doi: 10.1097/01.bor.0000172800.49120.97.
- Background: PubMed 23873317Heekin 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.
- Background: PubMed 31523751Budarick 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.
- Background: PubMed 10225800Kirkley A, Webster-Bogaert S, Litchfield R, Amendola A, MacDonald S, McCalden R, Fowler P. The effect of bracing on varus gonarthrosis. J Bone Joint Surg Am. 1999 Apr;81(4):539-48. doi: 10.2106/00004623-199904000-00012.
- Background: PubMed 15208174Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, Bombardier C, Felson D, Hochberg M, van der Heijde D, Dougados M. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis. 2005 Jan;64(1):29-33. doi: 10.1136/ard.2004.022905. Epub 2004 Jun 18.
- Background: PubMed 13498604KELLGREN 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.
- Background: PubMed 18759314Murphy 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.
- Background: PubMed 22632687Suri 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.
- Background: PubMed 25499679Cherian 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet L Ronsky, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levitation 2 Tri-Compartment Offloader (TCO) knee brace and Knee sleeve in people with Knee Osteoarthritis, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS pain score - chair rise (3 month) (time frame: Change from baseline to 3-month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05543486, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.