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

26 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new knee brace called the Levitation Tri-compartment Offloader (TCO) for people with knee osteoarthritis affecting multiple parts of their knee. The brace helps by storing energy when the knee bends and using it to assist in straightening the knee, reducing pain and improving function. The study aims to see if this brace is more effective than current treatments.

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 data supports the effectiveness of the treatment Levitation Knee Brace for osteoarthritis?

Research shows that the Levitation knee brace helps reduce pain and improve knee function in people with knee osteoarthritis by providing support and reducing stress on the knee. Similar braces have also been effective in reducing pain and improving comfort and function in patients with knee osteoarthritis. ^{1 2 3 4 5}

Is the Levitation Knee Brace safe for humans?

The Levitation Knee Brace, also known as a tricompartment offloader (TCO) knee brace, has been studied for its effects on knee osteoarthritis and has shown to reduce pain and improve function without any reported safety concerns. Other knee braces, like the unloader and distraction-rotation braces, have also been evaluated for osteoarthritis and found to be safe, providing pain relief and improved comfort. ^{1 2 3 4 6}

How is the Levitation Knee Brace treatment different from other treatments for knee osteoarthritis?

The Levitation Knee Brace is unique because it provides an assistive knee extension moment, aiming to unload all three compartments of the knee, which can reduce pain and improve movement for people with knee osteoarthritis. This is different from other braces that typically focus on only one compartment of the knee. ^{1 2 4 6 7}

Research Team

Janet L Ronsky, PhD

Principal Investigator

University of Calgary

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Tricompartment offloader knee brace reduces sagittal plane knee moments, quadriceps muscle activity, and pain during chair rise and lower in individuals with knee osteoarthritis. [2023]

2. England pubmed.ncbi.nlm.nih.gov

The clinical effect of an unloader brace on patients with osteoarthritis of the knee, a randomized placebo controlled trial with one year follow up. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Three-month efficacy of three knee braces in the treatment of medial knee osteoarthritis in a randomized crossover trial. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical effectiveness and safety of a distraction-rotation knee brace for medial knee osteoarthritis. [2016]

5. Japan pubmed.ncbi.nlm.nih.gov

Effects of the WISH-type S-form Hip Brace on Muscle Strength in Patients with Osteoarthritis of the Hip: A Short-term Longitudinal Study. [2022]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Effects of the off-loading brace on the activation of femoral muscles -a preliminary study-. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Role of bracing in the management of knee osteoarthritis. [2013]