Biomechanical Footwear for Knee Osteoarthritis

Recruiting at 1 trial location

Overseen By Kenneth Sams

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Geisinger Clinic

Must not be taking: Corticosteroids

Disqualifiers: BMI > 40, Rheumatic disease, 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: 12 months

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AposHealth, a non-surgical, home-based method for knee osteoarthritis (OA). The researchers aim to determine if AposHealth can serve as an alternative to knee replacement surgery and aid recovery post-surgery. Participants will use a special device at home, gradually increasing wear time, with follow-up appointments to adjust the treatment. The trial seeks individuals with knee OA who experience significant knee pain and have had symptoms for at least six months. As an unphased trial, this study offers the chance to explore a potentially innovative treatment for knee OA in a flexible, home-based setting.

Do I need to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have had corticosteroid injections in the knees in the previous 6 weeks, you are not eligible to participate.

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, if you have had corticosteroid injections in the knees in the past 6 weeks, you would not be eligible to participate.

What prior data suggests that this biomechanical footwear is safe for knee osteoarthritis?

Research has shown that AposHealth, a non-invasive treatment, is well-tolerated by people with knee osteoarthritis (OA). Studies have found that this therapy significantly reduces pain and improves movement and quality of life for these patients. No major reports of harmful side effects have emerged, indicating that the treatment is safe for use.

For those who have had a total knee replacement (TKR), researchers are studying the combination of AposHealth with regular physical therapy. This combination has shown promise as a tool for recovery after surgery, further supporting its safety and effectiveness. Overall, AposHealth appears to be a safe option for managing knee OA and aiding recovery after knee surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer a blend of innovative approaches to managing knee osteoarthritis and post-surgery recovery. AposHealth is unique because it uses biomechanical footwear to potentially improve gait and reduce knee pain through a non-invasive method. This approach allows patients to gradually increase weight-bearing activities, which can be integrated seamlessly into daily routines. In contrast, the Total Knee Replacement (TKR) and the combination of traditional physical therapy with AposHealth aim to enhance recovery post-surgery, with AposHealth potentially accelerating rehabilitation by promoting natural movement patterns. These options could provide alternatives or complements to conventional treatments, like pain medications and standard physical therapy, by offering personalized, adaptive solutions.

What evidence suggests that AposHealth biomechanical footwear is effective for knee osteoarthritis?

Studies have shown that AposHealth, one of the treatments tested in this trial, can greatly reduce pain and improve movement in people with knee osteoarthritis (OA). Research indicates a 49% reduction in pain and a 46% improvement in movement, both exceeding levels considered important for treatment success. Long-term evidence also shows that AposHealth can enhance quality of life for those with knee OA. Additionally, one study found that 89% of patients eligible for knee replacement avoided surgery for up to six years after using this treatment. This approach, which focuses on improving body movement, offers a promising non-surgical option for managing knee OA symptoms. Meanwhile, another arm of this trial involves Total Knee Replacement (TKR), a surgical procedure that serves as a comparator to evaluate the effectiveness of AposHealth. ^{1 2 3 5 6}

Who Is on the Research Team?

Michael Suk, MD

Principal Investigator

Geisinger Clinic

Are You a Good Fit for This Trial?

This trial is for men and women aged 45-80 with knee osteoarthritis, who've had symptoms for at least six months. They must have a certain level of pain and be able to understand and sign the consent form in English. It's not for those with severe balance issues, BMI over 40, recent steroid injections in the knees, major past knee surgeries (except arthroscopy), more severe non-knee pain, inflammatory diseases or recent mental health conditions.

Inclusion Criteria

ACR clinical criteria for OA of the knee

My pain level is at least moderate, scoring 5 or more.

I have had knee pain from arthritis for at least 6 months.

Exclusion Criteria

I have been diagnosed with a mental health condition like depression or anxiety in the last 3 months.

I have had balance issues, including more than 2 falls, dizziness leading to falls, or I use a walking aid.

I had major knee surgery, but it was more than 6 months ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Evaluation and Calibration

Initial consultation and calibration of the Apos device in the clinic, followed by a home-based treatment plan

1 week

1 visit (in-person), 1 visit (virtual)

Treatment

Participants receive AposHealth treatment, gradually increasing usage time up to 60 minutes with about 40% weight-bearing

12 months

Follow-up visits at 1, 3, 6, 9, and 12 months (in-person), remote follow-up after 1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• AposHealth
• Total Knee Replacement (TKR)

Trial Overview The study tests AposHealth as an alternative to Total Knee Replacement (TKR) surgery for knee osteoarthritis patients and as a post-operative tool after TKR. AposHealth is a home-based biomechanical treatment designed to improve joint function without surgery.

How Is the Trial Designed?

Group I: Post TKR traditional physical therapy (PT) and AposHealth Experimental Treatment 2 Interventions

Patients who have had a knee replacement and were assigned to the traditional PT+ AposHealth group will follow Geisinger post-operative rehab protocol and will also receive AposHealth and follow the rehabilitation protocol. AposHealth will start six weeks post-op and will continue for 12 months. Patients will receive AposHealth similar to the non-invasive group, i.e., will have an initial evaluation (IE) and calibration of the Apos device, have a remote FU after one week from IE and in-clinic FUs at 1, 3 6, 9 and 12 months.

Group II: AposHealth Experimental Treatment 1 Intervention

Following the initial consultation and calibration of the Apos device in the clinic, the patients will receive from his therapist a home-based treatment plan. This usually includes wearing the device for about 20 minutes with about 20% of weight-bearing (patient is instructed to wear the Apos and just be with the device and go about his/her daily routine). A gradual increase in usage time is prescribed reaching up to 60 min wear time with about 40% weight-bearing. Patients are requested to return to follow-up (FU) appointments after 1, 3, 6, 9 and 12 months. In addition, patients will have a remote FU after 1-week to confirm they use AposHealth as advised. During the follow-up appointment, re-assessment of clinical outcomes and gait patterns are performed and the calibration of the Apos device is adjusted as needed. The treatment plan is adjusted, and patients are encouraged to continue to wear the device regularly at home.

Group III: Total Knee Replacement (TKR) Active Control 1 Intervention

Patients will undergo TKR according to Geisinger's policy, guidelines and care protocol. The study baseline visit will occur 6 weeks postoperative for TKR groups.

AposHealth is already approved in United States, European Union, Canada for the following indications:

Approved in United States as AposHealth for:

• Knee osteoarthritis

Approved in European Union as AposHealth for:

• Knee osteoarthritis

Approved in Canada as AposHealth for:

• Knee osteoarthritis

Who Is Running the Clinical Trial?

Geisinger Clinic

Lead Sponsor

Trials

159

Recruited

1,976,000+

Apos Medical and Sports Technology Ltd.

Industry Sponsor

Trials

7

Recruited

700+

Apos Medical Assets Ltd. (AMA)

Collaborator

Trials

1

Recruited

150+

Published Research Related to This Trial

In a study of 220 participants with knee osteoarthritis, those using biomechanical footwear experienced a significant reduction in knee pain after 24 weeks, with a mean pain score improvement from 4.3 to 1.3, compared to a reduction from 4.0 to 2.6 in the control group.

The biomechanical footwear also showed improvements in physical function and stiffness, with fewer serious adverse events reported in the biomechanical group (2.7%) compared to the control group (8.3%), although none were related to the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Biomechanical Footwear on Knee Pain in People With Knee Osteoarthritis: The BIOTOK Randomized Clinical Trial. Reichenbach, S., Felson, DT., Hincapié, CA., et al.[2023]

Walking in custom-made biomechanical footwear (BF) led to significantly greater activation of knee stabilizing muscles, particularly the semitendinosus, lateral gastrocnemius, and tibialis anterior, compared to walking barefoot or with a knee brace.

The study suggests that BF may enhance muscle engagement during walking, which could be beneficial for rehabilitation purposes, indicating a need for further research on its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of biomechanical footwear on upper and lower leg muscle activity in comparison with knee brace and normal walking. Ylinen, J., Pennanen, A., Weir, A., et al.[2021]

A study involving 56 elderly women with knee osteoarthritis will assess the long-term effects of wearing minimalist shoes (Moleca®) for six months, focusing on pain relief and functional improvements in knee OA.

The trial aims to demonstrate that these shoes can reduce knee pain and improve joint function and gait biomechanics, offering a low-cost and accessible treatment option for managing osteoarthritis symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a long-term use of a minimalist footwear versus habitual shoe on pain, function and mechanical loads in knee osteoarthritis: a randomized controlled trial. Trombini-Souza, F., Fuller, R., Matias, A., et al.[2022]

In a case-control study analyzing footwear and osteoarthritis (OA) risks among participants, persistent users of high and narrow heeled shoes did not show a significant increase in knee or hip OA, suggesting that these shoe types may not be as detrimental as previously thought.

Interestingly, women who developed hip OA were found to have changed their footwear habits, possibly to alleviate pain, indicating that the relationship between shoe type and OA may be influenced by individual experiences rather than a direct causal link.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-reported adult footwear and the risks of lower limb osteoarthritis: the GOAL case control study. McWilliams, DF., Muthuri, S., Muir, KR., et al.[2021]

After 6 months of wearing flat, flexible footwear (mobility shoes), participants with knee osteoarthritis experienced an 18% reduction in knee loading, indicating improved biomechanics and potential pain relief.

The study also found that even after removing the mobility shoes, participants maintained a significant reduction in knee loading, suggesting that these shoes can help retrain gait mechanics beneficially for knee OA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in knee loading after use of specialized footwear for knee osteoarthritis: results of a six-month pilot investigation. Shakoor, N., Lidtke, RH., Wimmer, MA., et al.[2013]

Current literature suggests that biomechanical footwear may help alleviate knee pain in individuals with osteoarthritis, but the evidence is not strong enough to confirm its long-term effectiveness and safety.

Due to the high cost of biomechanical footwear (around $5,000) and the lack of robust evidence supporting its efficacy, routine use of this treatment is not recommended until further research confirms its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Biomechanical Footwear on Pain from Knee Osteoarthritis. Rodriguez-Merchan, EC., la Corte-Rodriguez, H., Roman-Belmonte, JM.[2022]

Lateral wedge orthotics effectively reduce the peak external knee adduction moment (EKAM) in both healthy individuals and those with medial knee osteoarthritis, while medial wedges may increase EKAM.

Modern footwear, including stability and mobility shoes, tends to increase EKAM compared to barefoot walking in individuals with medial knee OA, indicating a need for better footwear design to minimize knee stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of footwear on the external knee adduction moment - A systematic review. Radzimski, AO., Mündermann, A., Sole, G.[2022]

A review of 87 studies on running footwear revealed significant inconsistencies in how footwear characteristics are assessed and reported, highlighting a lack of standardized methods in the field.

Most studies focused on footwear classification and manufacturer details but failed to provide technical specifications, indicating a need for consensus to improve the quality of research and facilitate future systematic reviews.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurement and reporting of footwear characteristics in running biomechanics: A systematic search and narrative synthesis of contemporary research methods. Ramsey, C., Peterson, B., Hébert-Losier, K.[2023]

A customized gait treatment program using a biomechanical device significantly improved both gait parameters and quality of life in hip osteoarthritis patients over a 1-year study involving objective measurements and subjective questionnaires.

The most notable improvements in gait speed, cadence, and hip joint mechanics were observed within the first 3 months of treatment, with benefits sustained at 12 months, indicating the program's effectiveness as a long-term treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive outcomes following gait therapy intervention for hip osteoarthritis: A longitudinal study. Solomonow-Avnon, D., Herman, A., Levin, D., et al.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9194704/

The Effect of Biomechanical Footwear on Pain from Knee ... Biomechanical footwear for knee OA has been built up to diminish pain, ameliorate physical function, and conceivably decelerate sickness advancement.

2. aposhealth.com aposhealth.com/newsroom/new-research-shows-aposhealth-significantly-reduces-osteoarthritis-knee-pain/

New Study: AposHealth® Reduces Osteoarthritic Knee Pain 49% pain reduction and 46% function improvement (above the recommended 16% threshold for clinical significance); 22% improvement in the quality ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3603601/

Long-Term Effects of AposTherapy in Patients with ... The biomechanical therapy examined was shown to significantly reduce pain and improve function and quality of life of patients with knee OA over the long term.

4. aposhealth.com aposhealth.com/newsroom/novel-shoe-intervention-may-cut-low-back-pain-delay-knee-arthroplasty-in-osteoarthritis/

Novel Shoe Intervention May Cut Low Back Pain, Delay ... At 1 year after randomization, those who used the shoe-based intervention reported a significantly greater mean 3.5-point reduction in their ...

5. jheor.org jheor.org/article/117155.pdf

Reduction in Healthcare Resource Utilization Following ... Summary of outcomes of a non-invasive biomechanical therapy for patients with knee osteoarthritis. Journal of Orthopaedic Experience & Innovation. 2022;3(1) ...

6. aposhealth.co.uk aposhealth.co.uk/press-releases/apos-demonstrates-43-reduction-in-healthcare-utilization-and-costs-for-patients-with-knee-and-back-pain/

Apos® Demonstrates 43% Reduction in Healthcare ... Apos® Demonstrates 43% Reduction in Healthcare Utilization and Costs for Patients with Knee and Back Pain ... A recent study published in the ...