Knee Brace for Knee Osteoarthritis

Overseen By Mathieu Germain Robitaille, M.Sc. in kinesiology

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: TOPMED

Disqualifiers: Tricompartmental gonarthrosis, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new custom knee brace, or custom knee orthosis, designed for individuals with knee osteoarthritis, specifically medial gonarthrosis (arthritis affecting the inner knee). The researchers aim to determine if the brace can ease symptoms by aligning the knee and improving comfort. Participants will use the brace for eight weeks to assess its impact on daily life. Those with medial gonarthrosis who currently use a standard O3D knee brace may find this trial suitable. As an unphased trial, it offers a unique opportunity to explore innovative solutions for knee osteoarthritis and potentially enhance 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. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this knee orthosis is safe for treating knee osteoarthritis?

A previous study found knee braces to be a generally safe option for people with knee osteoarthritis. Reports show that these braces are well-tolerated, with very few side effects. Some users may experience mild discomfort or skin irritation, but these issues are usually minor and manageable.

Research also shows that custom knee braces, like the one tested in this trial, are designed to fit more comfortably and work better. This custom fit helps reduce potential discomfort and improves the overall experience for the user. Overall, evidence suggests that wearing a custom knee brace is a safe way to manage symptoms of knee osteoarthritis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for knee osteoarthritis, which often involve pain medications or invasive procedures, the custom knee orthosis targets the condition by providing personalized support and alignment. This knee brace is unique because it is tailored specifically to the individual's knee structure, especially for those with medial gonarthrosis, offering a more precise fit and potentially reducing pain and improving mobility more effectively. Researchers are excited about this approach because it offers a non-invasive alternative that can be used continuously without the side effects associated with medications.

What evidence suggests that this knee orthosis is effective for knee osteoarthritis?

Research has shown that custom knee braces can reduce pain and improve movement for people with knee osteoarthritis. This trial will evaluate the effectiveness of a custom knee orthosis for patients with medial gonarthrosis. One study found that an unloader brace, a special type of custom knee brace, significantly reduced pain and improved function. Another study highlighted that custom braces are particularly effective for treating osteoarthritis on the inner side of the knee, often outperforming some other treatments. However, some research suggests that after 12 months, braces might not significantly reduce pain or improve quality of life. Overall, custom knee braces may offer short-term relief and improved movement for those with knee osteoarthritis. ^{6 7 8 9 10}

Who Is on the Research Team?

Edith Martin, Phd.

Principal Investigator

TOPMED

Are You a Good Fit for This Trial?

This trial is for individuals with knee osteoarthritis, a common joint condition that causes pain and stiffness. Participants should be seeking treatment to improve their daily activities limited by this chronic disease. Specific eligibility criteria are not provided.

Inclusion Criteria

Receiving a regular model of the O3D orthosis

I have arthritis in the inner part of my knee.

Exclusion Criteria

Having completed the delivery appointment for an O3D orthosis

I have arthritis in all three compartments of my knee.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a custom knee orthosis to treat knee gonarthrosis symptoms

8 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Custom Knee Orthosis

Trial Overview The study is testing the effectiveness of a custom knee orthosis designed by O3D Inc., which aims to alleviate symptoms of knee gonarthrosis (osteoarthritis) by compensating for biomechanical deficits in patients.

How Is the Trial Designed?

Group I: medial gonarthrosis Experimental Treatment 1 Intervention

Patients with medial gonarthrosis

Custom Knee Orthosis is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Knee Orthosis for:

• Knee gonarthrosis
• Osteoarthritis

Approved in United States as Knee Orthosis for:

• Knee gonarthrosis
• Osteoarthritis
• Post-operative knee support

Approved in Canada as Knee Orthosis for:

• Knee gonarthrosis
• Osteoarthritis

Who Is Running the Clinical Trial?

TOPMED

Lead Sponsor

Trials

10

Recruited

290+

O3D inc.

Collaborator

Trials

1

Recruited

50+

Natural Sciences and Engineering Research Council, Canada

Collaborator

Trials

63

Recruited

3,000+

Published Research Related to This Trial

A custom-made hinged knee brace designed for patients with medial knee osteoarthritis significantly reduced the peak knee adduction moment (KAM) compared to a standard hinged knee brace, indicating improved biomechanical support (P=0.004).

The custom brace also allowed for a greater peak knee flexion angle during the swing phase of walking, enhancing mobility (P=0.004), which is crucial for patients with knee OA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a custom-made hinged knee brace with knee flexion support for patients with knee osteoarthritis:a preliminary study. Ota, S., Kanai, A., Torii, Y., et al.[2022]

The study involving 17 healthy participants demonstrated that using a 4-point knee orthosis significantly reduces maximum knee abduction and increases knee adduction, indicating effective load relief for osteoarthritis.

The knee brace caused a shift in knee movement patterns in 69% to 75% of dynamic tests, suggesting that individual movement patterns may influence the effectiveness of the brace, highlighting the need for personalized approaches in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a knee brace in dynamic motion-An instrumented gait analysis. Siebers, HL., Eschweiler, J., Pinz, J., et al.[2020]

Knee sleeves may help reduce pain and provide subjective improvement for patients with knee osteoarthritis, but they do not significantly affect disability levels.

Valgus knee bracing shows promise in decreasing pain and disability in medial knee osteoarthritis, improving quality of life and knee function, although results can be inconsistent and side effects like discomfort and thrombophlebitis have been reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical practice guidelines for rest orthosis, knee sleeves, and unloading knee braces in knee osteoarthritis. Beaudreuil, J., Bendaya, S., Faucher, M., et al.[2020]

The study involving 16 patients with mild-to-moderate medial knee osteoarthritis found that both one-degree-of-freedom (1-DOF) and two-degrees-of-freedom (2-DOF) knee orthoses significantly reduced the external knee adduction moment during walking, indicating potential benefits in alleviating knee stress.

The two-DOF knee orthosis improved gait parameters such as walking speed and stride length compared to the one-DOF orthosis, and it was reported to be more comfortable during deep knee flexion, suggesting it may enhance patient compliance and overall effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Knee Orthosis with Two Degrees of Freedom Joint Design on Gait and Sit-to-Stand Task in Patients with Medial Knee Osteoarthritis. Fesharaki, SA., Farahmand, F., Saeedi, H., et al.[2022]

Customized knee braces were tested on three normal subjects to measure the forces and moments at the hinges during various activities, revealing that hinge design had only moderate differences in performance.

However, significant mismatches in knee motion and brace motion were observed when hinges were misaligned by 12 mm, affecting ligament tension and potentially causing discomfort, highlighting the importance of proper brace design and placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The forces in a knee brace as a function of hinge design and placement. Regalbuto, MA., Rovick, JS., Walker, PS.[2017]

A systematic review of four trials involving 444 patients with knee osteoarthritis found that braces and laterally wedged insoles can significantly improve pain and physical function compared to control groups, with braces showing better outcomes than neoprene sleeves.

Laterally wedged insoles not only reduced the intake of non-steroidal anti-inflammatory drugs (NSAIDs) by 23.9% but also had better patient compliance compared to neutral insoles, although strapped insoles were associated with more adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Braces and orthoses for treating osteoarthritis of the knee. Brouwer, RW., Jakma, TS., Verhagen, AP., et al.[2018]

New knee brace designs show promise in improving patient outcomes for various conditions, including post-injury recovery and knee osteoarthritis, compared to traditional braces.

The article reviews significant advancements in knee bracing technology, supported by clinical research, highlighting their potential benefits in rehabilitation and management of knee-related issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovations in functional and rehabilitative knee bracing. Hewlett, J., Kenney, J.[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]

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]

A systematic review of 13 studies involving 1356 participants found inconclusive evidence regarding the effectiveness of knee braces and foot/ankle orthoses in reducing pain, improving function, and enhancing quality of life for individuals with knee osteoarthritis.

Moderate-quality evidence indicated no significant difference in pain and function between patients using laterally wedged insoles and those using neutral insoles, suggesting that the optimal choice of orthosis for knee osteoarthritis remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Braces and orthoses for treating osteoarthritis of the knee. Duivenvoorden, T., Brouwer, RW., van Raaij, TM., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7173742/

Braces and orthoses for treating osteoarthritis of the knee - PMC probably results in little or no difference in reducing pain and improving function, stiffness and quality of life after 12 months (moderate‐quality evidence).

2. sciencedirect.com sciencedirect.com/science/article/pii/S1063458424013657

Knee braces for knee osteoarthritis: A scoping review and ... The effectiveness of self-adjustable custom and off-the-shelf bracing in the treatment of varus gonarthrosis. J Bone Joint Surg Am, 88 (12) (2006 Dec), pp ...

3. oarsijournal.com oarsijournal.com/article/S1063-4584%2821%2900011-X/fulltext

Effectiveness, safety, and cost–utility of a knee brace in ... The ERGONOMIE RCT demonstrated significant clinical benefits of an unloader custom-made knee brace in terms of improvements in pain, function, ...

4. esskajournals.onlinelibrary.wiley.com esskajournals.onlinelibrary.wiley.com/doi/10.1002/ksa.12312

Knee braces and foot orthoses multimodal 3‐month treatment ... The VER-brace obtained more effectiveness than FO on pain and KAM after 3 months for medial knee osteoarthritis and the combined treatment did ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6204633/

Effectiveness of Valgus Offloading Knee Braces in the ... Objective: To determine the effectiveness of valgus offloader braces in improving clinical outcomes for patients with medial compartment knee osteoarthritis.

6. sciencedirect.com sciencedirect.com/science/article/pii/S106345842100011X

Effectiveness, safety, and cost–utility of a knee brace in ... This pragmatic, multicenter, open-label, randomized controlled trial (RCT) aimed to compare the effectiveness, safety, and cost–utility of a custom-made knee ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2881986/

Medial Knee Osteoarthritis Treated by Insoles or Braces Our data suggest a laterally wedged insole may be an alternative to valgus bracing for noninvasively treating symptoms of medial knee OA.

8. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39936&ver=14

Proposed LCD - Knee Orthoses (DL33318) The proposed LCD proposes modifications to the coverage criteria for knee orthoses with single or double upright, adjustable flexion and extension joint, medial ...

9. oarsijournal.com oarsijournal.com/article/S1063-4584(24)01365-7/fulltext

Knee braces for knee osteoarthritis: A scoping review and ... Knee braces for knee osteoarthritis: A scoping review and narrative synthesis of interventions in randomised controlled trials

10. blueshieldca.com blueshieldca.com/content/dam/bsca/en/provider/docs/medical-policies/Knee-Braces-Custom.pdf

Medical Policy BSC1.05 Knee Braces (Custom) ... I. Custom-fabricated functional or derotation knee braces may be considered medically necessary, when all of the following are met (this ...