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

50 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Custom Knee Orthosis, Knee Orthosis, Knee Brace, KO for knee osteoarthritis?

Research shows that knee braces can reduce pain and improve physical function in people with knee osteoarthritis. Different types of knee braces, like the VER-brace, have been found to offer additional comfort and effectiveness, which can help people stick with the treatment. ^{1 2 3 4 5}

Is wearing a knee brace for knee osteoarthritis generally safe for humans?

Research indicates that knee braces for knee osteoarthritis are generally safe and can reduce pain and improve function. Some discomfort may occur, but certain designs, like the VER-brace, offer better comfort and compliance. ^{4 5 6 7 8}

How is the custom knee orthosis treatment different from other treatments for knee osteoarthritis?

The custom knee orthosis is unique because it is designed to reduce the knee adduction moment (the inward force on the knee) while allowing for better knee flexion during walking, which is not typically achieved by standard knee braces. ^{1 2 7 9 10}

What is the purpose of this trial?

The aging population is steadily increasing, partly due to increasing life expectancy. At the same time, chronic diseases, including those affecting the musculoskeletal system (e.g., osteoarthritis), whose prevalence increases with age, limit the daily activities of those affected and thus affect more and more people. Arthrosis is the most common form of these diseases worldwide. According to the l'Institut de la statistique du Québec, nearly one in two Quebecers aged 15 and over is affected by a chronic health problem. Knee orthosis is one form of treatment that helps patients suffering from knee gonarthrosis. This treatment aims to compensate for certain biomechanical deficits in patients. A variety of joint configurations exists to target specific biomechanical deficits. A constant challenge for companies manufacturing orthoses is transmitting the orthosis's biomechanical effect to the patient. The desired effect requires a change in the forces applied inside the knee, but the orthosis cannot directly transmit forces to the patient's bones due to its external nature to the body. Customization of orthoses is crucial to improve the transmission of the biomechanical effect as well as tolerance to it. O3D Inc. aims to validate the effectiveness of its new custom orthosis for treating knee gonarthrosis symptoms.

Research Team

Edith Martin, PhD

Principal Investigator

TOPMED

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

References

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

Braces and orthoses for treating osteoarthritis of the knee. [2023]

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

Braces and orthoses for treating osteoarthritis of the knee. [2018]

3. China pubmed.ncbi.nlm.nih.gov

Innovations in functional and rehabilitative knee bracing. [2020]

4. 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]

5. Oman 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. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

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

7. Japan 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. [2022]

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

The forces in a knee brace as a function of hinge design and placement. [2017]

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

The effect of a knee brace in dynamic motion-An instrumented gait analysis. [2020]

10. France pubmed.ncbi.nlm.nih.gov

Clinical practice guidelines for rest orthosis, knee sleeves, and unloading knee braces in knee osteoarthritis. [2020]