Knee Brace for Osteoarthritis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Must not be taking: Corticosteroids, Hyaluronic acid, PRP

Disqualifiers: Arthroplasty, Rheumatoid arthritis, Parkinson's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new knee brace designed for individuals with knee osteoarthritis (OA) affecting multiple parts of the knee. The Levitation Knee Brace, also known as the Levitation Tri-compartment Offloader (TCO) brace, aims to relieve pain and improve knee function by supporting all three knee compartments. Participants will either try this new brace, use a standard knee sleeve, or self-manage without any brace to determine which option works best. Suitable candidates have knee OA with pain that worsens during activities like squatting or climbing stairs, and experience less pain in the other knee. As an unphased trial, this study provides a unique opportunity to explore new methods for managing knee OA and improving quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does exclude participants who have received certain injections recently, like corticosteroids or hyaluronic acid, which might suggest some restrictions.

What prior data suggests that this knee brace is safe for managing knee osteoarthritis?

Research shows that most people find the Levitation Tri-compartment Offloader (TCO) knee brace comfortable. In earlier studies, some users experienced knee or hamstring pain while wearing the brace, but no negative reactions to the brace materials occurred. Additionally, a survey found that 95% of users reported reduced pain after using the Levitation brace. Thus, while some might feel minor discomfort, the brace is safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for knee osteoarthritis, which often include pain relievers, physical therapy, or traditional knee braces, the Levitation 2 Tri-Compartment Offloader (TCO) knee brace offers a unique approach. Researchers are excited about this brace because it actively offloads pressure from all three compartments of the knee, potentially providing superior support and pain relief. This design might help improve mobility and reduce discomfort more effectively than regular knee sleeves or self-management strategies. By focusing on reducing mechanical stress on the knee in a targeted way, the Levitation 2 TCO brace could offer a new level of relief for those struggling with osteoarthritis.

What evidence suggests that the Levitation Knee Brace is effective for osteoarthritis?

Research shows that the Levitation Tri-compartment Offloader (TCO) knee brace, which participants in this trial may receive, can help treat knee osteoarthritis (OA). Studies have found that this brace significantly reduces pressure on the knee during activities like standing up from a chair, leading to less stress and possibly less pain. Unlike most braces that support only one part of the knee, the TCO brace aids all three areas. Early results suggest that users experience improved knee function, making everyday activities easier. ^{1 2 3 4 6}

Who Is on the Research Team?

Janet L Ronsky, PhD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for Canadian adults aged 18-80 with moderate to severe knee osteoarthritis, experiencing pain during activities like squatting or climbing stairs. Eligible participants must have less pain in one knee compared to the other and a specific range of knee movement. They should understand English and be able to wear the Levitation brace.

Inclusion Criteria

Able to hear and understand study information and instructions in English

Must be able to be fit with a Levitation knee brace

I have arthritis in my knee cap and possibly the main knee joint.

Exclusion Criteria

Known allergy or adverse skin reaction to neoprene

Any contraindications for knee bracing

I have a history of rheumatoid arthritis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Review and Design

Review and improve clinical trial objectives, design, and methodology

4 weeks

Treatment

Participants are fitted with either the TCO knee brace or a knee sleeve and instructed to wear it for 3 or more hours per day for 3 months

12 weeks

Baseline, 6-week, and 3-month follow-ups

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Knowledge Translation

Interpret study results and create a knowledge translation plan

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Levitation Knee Brace

Trial Overview

The study compares the Levitation Tri-compartment Offloader (TCO) knee brace, designed to offload all three compartments of the knee joint, against standard care which includes regular knee sleeves. The goal is to see if TCO can better relieve pain and improve function in patients with multi-compartmental osteoarthritis.

How Is the Trial Designed?

Group I: Levitation 2 Tri-Compartment Offloader (TCO) knee brace Experimental Treatment 1 Intervention

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.

Group II: Knee sleeve Active Control 1 Intervention

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.

Group III: Standard of Care Self-Management Active Control 1 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 Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Bone and Joint Health Strategic Clinical Network (BJH SCN)

Collaborator

Trials

1

Recruited

30+

McCaig Institiute of Bone and Joint Health

Collaborator

Trials

1

Recruited

30+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Alberta Strategy for Patient Oriented Research Support Unit (AbSPORU)

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

The custom-made valgus knee brace (OdrA) significantly reduced pain and improved function in patients with medial knee osteoarthritis, with 76% of participants showing clinical improvement after one year.

The brace also led to a notable decrease in the use of analgesics and NSAIDs, indicating its effectiveness in managing symptoms, while maintaining an acceptable safety profile with only one serious adverse effect reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical effectiveness and safety of a distraction-rotation knee brace for medial knee osteoarthritis. Ornetti, P., Fortunet, C., Morisset, C., et al.[2016]

In a study involving 24 patients with knee osteoarthritis, all three types of knee braces (V3P-brace, VER-brace, and ACL-brace) significantly reduced pain and improved function, with pain relief ranging from 10% to 40%.

The VER-brace not only provided the most comfort and ease of daily use but also resulted in the lowest reduction in knee adduction moment (KAM), suggesting it may enhance patient compliance with brace treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-month efficacy of three knee braces in the treatment of medial knee osteoarthritis in a randomized crossover trial. Robert-Lachaine, X., Dessery, Y., Belzile, ÉL., et al.[2020]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12164062/

A feasibility randomised trial evaluating the levitation tri- ...

This study supports the feasibility of a full scale RCT evaluating the clinical effectiveness of the TCO knee brace compared to the current (conservative) ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05543486

Clinical Evaluation of the Levitation Knee Brace

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 ...

3.

pilotfeasibilitystudies.biomedcentral.com

pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-025-01660-2

A feasibility randomised trial evaluating the levitation tri ...

This study supports the feasibility of a full scale RCT evaluating the clinical effectiveness of the TCO knee brace compared to the current (conservative) ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1350453323000279

Tricompartment offloader knee brace reduces sagittal ...

Study results demonstrate that the TCO significantly reduces net knee flexion moment and quadriceps muscle activity during a chair rise and lower. •. Knee ...

5.

trial.medpath.com

trial.medpath.com/clinical-trial/f9d6476db8c2cb98/clinical-evaluation-levitation-knee-brace-knee-osteoarthritis

Clinical Evaluation of the Levitation Knee Brace - MedPath

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 ...

6.

springloadedtechnology.com

springloadedtechnology.com/2020/09/the-future-of-knee-osteoarthritis-care/

The Future of Knee Osteoarthritis Treatment: Best Practice ...

In a survey based study of current Levitation brace users, 95% of users reported reduced pain since using the Levitation brace. As well, ...