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

Trial Summary

What is the purpose of this trial?

This will be a prospective, randomized, noninferiority clinical trial comparing rehabilitation methods post-total knee arthroplasty (TKA). Population of interest is adult hip/knee clinic patients over age 18 who are indicated for unilateral primary total knee arthroplasty. All TKA patients are prescribed physical therapy (PT) for rehabilitation post-operatively. The investigators will compare this current treatment with a new, validated, wearable smart knee brace (FM2 Knee Brace) that can be used for rehabilitation post-TKA. Following enrollment in the study, the investigators will match and randomize participants into two cohorts (outpatient PT versus FM2 Knee Brace). Outpatient PT group will be prescribed routine six-week course of outpatient PT (no pool exercises, remainder at therapist's discretion) to start as soon as possible upon discharge. The FM2 Knee Brace group will complete device set up at pre-op visit and will be prescribed 3-4 exercises to complete at their discretion over six weeks. The investigators will collect measurements of knee flexion, extension, total arc of motion at pre-op visit and at 6-week, 3-month, and 1-year post-op visits. The investigators will also plan to record additional PROs, therapy compliance, and complication rates. The investigators will compare the two groups to test whether the new FM2 Knee Brace is noninferior to regular PT when recovering from TKA, and if the new technology could be an alternative to outpatient PT.

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 data supports the effectiveness of the FM2 Knee Brace treatment for knee arthropathy?

Research shows that knee braces can reduce pain and improve function in people with knee osteoarthritis by decreasing the knee adduction moment, which is a measure of the load on the knee joint. Innovative knee brace designs have been found to improve patient outcomes compared to traditional braces, making them a promising option for managing knee conditions. ^{1 2 3 4 5}

Is the Smart Orthotic (FM2 Knee Brace) safe for use in humans?

Research on knee braces, including the FM2 Knee Brace, suggests they are generally safe for use in humans. Studies have shown that knee braces can help with pain relief and improve function in people with knee osteoarthritis, although individual experiences may vary. ^{1 5 6 7 8}

What makes the FM2 Knee Brace treatment unique for knee arthropathy?

The FM2 Knee Brace, also known as the Smart Orthotic, is unique because it features a two-degrees-of-freedom joint design that optimizes the knee's movement, potentially improving gait and sit-to-stand tasks for patients with knee osteoarthritis. This innovative design aims to enhance biomechanical and clinical effectiveness compared to traditional knee braces. ^{1 2 3 6 9}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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 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]

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]

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]

References

1. China pubmed.ncbi.nlm.nih.gov

Innovations in functional and rehabilitative knee bracing. [2020]

2. England 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. [2018]

3. 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]

4. England pubmed.ncbi.nlm.nih.gov

Kinematic study of the overall unloading brace for the knee. [2023]

5. 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]

6. Czech Republic pubmed.ncbi.nlm.nih.gov

[Effect of Unloading Knee Brace on Dynamic Parameters of the Stance Phase of Gait in Patients with Knee Osteoarthritis]. [2019]

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

The current state of functional knee bracing research. A review of the literature. [2017]

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

Use of a knee-brace for control of tibial translation and rotation. A comparison, in cadavera, of available models. [2016]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Acute effects of different orthotic interventions on knee loading parameters in knee osteoarthritis patients with varus malalignment. [2018]