Smart Orthotic vs Physical Therapy for Knee Arthropathy

Overseen By Kyle Geiger, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nicolas Noiseux, MD, MS, FRCSC

Disqualifiers: Prior knee surgery, BMI > 40, others

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

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to aid recovery after knee replacement surgery. One group will attend regular physical therapy sessions, while the other will use a smart knee brace (FM2 Knee Brace) to guide exercises at home. The researchers aim to determine if the smart knee brace is as effective as traditional physical therapy. Individuals undergoing knee replacement, who own a smartphone, and plan to recover at home may qualify for this study. As an unphased trial, this study provides a unique opportunity to explore innovative recovery methods and contribute to advancements in post-surgical care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the FM2 Knee Brace is safe for rehabilitation post-TKA?

Research has shown that smart orthotic devices, such as the FM2 Knee Brace, are generally safe for use after knee surgery. Studies suggest that these smart knee braces can aid recovery from surgeries for knee osteoarthritis, similar to recovery after a total knee replacement. These devices track knee movements and assist with exercises. So far, research has not identified any major safety issues.

Although no serious side effects have been reported, it is important to note that the FM2 Knee Brace remains under testing. While early results appear promising, further research is necessary to confirm its safety and effectiveness. Prospective participants should consult their healthcare team to understand any potential risks before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FM2 Knee Brace, a smart orthotic device, because it offers a high-tech alternative to traditional physical therapy for knee arthropathy. Unlike standard treatments that rely on regular visits to a physical therapist, this smart orthotic uses advanced sensors and real-time feedback to support and enhance joint function directly, providing personalized, continuous care. This innovative approach could lead to more convenient and potentially faster improvements in mobility and pain management for patients.

What evidence suggests that this trial's treatments could be effective for knee arthropathy?

Research has shown that the Smart Orthotic FM2 Knee Brace, which participants in this trial may receive, could aid recovery after knee surgery. This brace uses technology to track and improve movement, potentially matching or even surpassing traditional physical therapy. One study found it monitored knee movements with 98.48% accuracy, effectively guiding rehabilitation exercises. Other studies suggest it might reduce pain and improve knee function post-surgery. This trial will compare the Smart Orthotic FM2 Knee Brace with outpatient physical therapy, providing insights into whether this new technology could serve as a strong alternative to regular physical therapy for those recovering from total knee replacement surgery. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

Adults aged 18-100 who need a total knee replacement and can go home after surgery. They must have a smartphone to use with the FM2 Knee Brace app. People with a BMI over 40, previous knee surgeries, or manipulation under anesthesia are not eligible.

Inclusion Criteria

I am recommended to have a total knee replacement.

I will be discharged to my home after surgery.

Possess a smartphone with capabilities to use the FocusMotion app and FM2 Knee Brace

Exclusion Criteria

I have had surgery on the same knee before.

BMI > 40

I have had a procedure to move my knee while under anesthesia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Device setup for FM2 Knee Brace group and baseline measurements of knee flexion, extension, and total arc of motion

1 visit

1 visit (in-person)

Treatment

Participants undergo rehabilitation post-TKA using either outpatient PT or FM2 Knee Brace for six weeks

6 weeks

Routine visits as per rehabilitation protocol

Follow-up

Participants are monitored for knee range of motion, therapy compliance, and complication rates at 6-week, 3-month, and 1-year post-op visits

1 year

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• FM2 Knee Brace
• Outpatient Physical Therapy
• Smart Orthotic

Trial Overview This study is comparing two ways to recover from knee replacement surgery: traditional outpatient physical therapy versus using a smart knee brace called FM2. Participants will be randomly placed in one of these two groups and followed up for one year.

How Is the Trial Designed?

Group I: Smart Orthotic Device (FM2 Knee Brace) Experimental Treatment 1 Intervention

Group II: Outpatient Physical Therapy Active Control 1 Intervention

FM2 Knee Brace is already approved in United States for the following indications:

Approved in United States as FM2 Knee Brace for:

• Rehabilitation post-total knee arthroplasty (TKA)

Who Is Running the Clinical Trial?

Nicolas Noiseux, MD, MS, FRCSC

Lead Sponsor

Trials

1

Recruited

80+

Scott Muffly

Lead Sponsor

Trials

1

Recruited

80+

Nicolas Noiseux, MD FRCSC

Lead Sponsor

Trials

1

Recruited

80+

Published Research Related to This Trial

Foot orthoses may be more effective than knee braces in improving pain and function for individuals with knee osteoarthritis, while both types of devices effectively reduce the knee adduction moment.

The review of 31 studies indicates that patients with medial compartment knee OA can benefit from using either foot orthoses or knee braces, and combining both may lead to even greater improvements in pain and function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of orthotic devices on knee adduction moment, pain and function in medial compartment knee osteoarthritis: a literature review. Baghaei Roodsari, R., Esteki, A., Aminian, G., et al.[2018]

The overall unloading brace (OUB) significantly altered knee kinematics in 32 adults, increasing the proximal-distal range of motion during both walking and jogging, which may help reduce joint stress in patients with knee injuries or osteoarthritis.

The OUB also decreased rotational movements of the knee, suggesting it could improve stability and potentially aid in rehabilitation, although further studies are needed to explore its full clinical benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kinematic study of the overall unloading brace for the knee. Guo, L., Luo, Y., Zhou, L., et al.[2023]

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]

Functional knee-braces can effectively limit abnormal movements in the knee, reducing tibiofemoral translation by 10 to 75% under mechanical loading conditions, which suggests they may help in managing knee stability.

The effectiveness of these braces varies significantly, particularly in their ability to control internal-external rotation, indicating that not all braces provide the same level of support for knee injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a knee-brace for control of tibial translation and rotation. A comparison, in cadavera, of available models. Wojtys, EM., Loubert, PV., Samson, SY., et al.[2016]

In a study of 52 patients with knee osteoarthritis, the ankle-foot orthosis (AFO) and laterally wedged shoes significantly reduced the knee adduction moment (KAM), which is beneficial for unloading the medial compartment of the knee, compared to standard shoes.

The AFO also increased the knee flexion moment (KFM) by 26% compared to control, indicating a potential change in knee mechanics, but the implications of this increase for osteoarthritis management need further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute effects of different orthotic interventions on knee loading parameters in knee osteoarthritis patients with varus malalignment. Mauricio, E., Sliepen, M., Rosenbaum, D.[2018]

Current research on functional knee bracing is extensive, but there is a lack of specific data to help clinicians choose the right brace for individual patient needs.

The authors suggest that future studies should focus on the physiological effects of knee braces and that manufacturers should take more responsibility for validating their designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The current state of functional knee bracing research. A review of the literature. Cawley, PW., France, EP., Paulos, LE.[2017]

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 use of a prophylactic knee brace in patients with knee osteoarthritis showed significant short-term improvements in vertical reaction forces on the unaffected limb, indicating a potential benefit in gait dynamics during walking.

While the brace did not lead to significant changes in subjective pain or function assessments, it did result in a prolonged stance phase in both limbs, suggesting that the brace may have lasting effects on gait mechanics even after removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of Unloading Knee Brace on Dynamic Parameters of the Stance Phase of Gait in Patients with Knee Osteoarthritis]. Lehnertová, M., Siudová, L., Janura, M., et al.[2019]

Citations

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Validation of a Smart Knee Brace - PMC The Digital Knee® is a promising approach to improving post-operative rehabilitation outcomes in patients with osteoarthritis. The Digital Knee ...

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Enhanced design and performance evaluation of a novel ... Using finite element analysis and CAD-based modeling, studies evaluate the impact of orthotic devices on knee joint stress, particularly in ...