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

Trial Summary

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 data supports the idea that Biomechanical Footwear for Knee Osteoarthritis is an effective treatment?

The available research shows mixed results about the effectiveness of Biomechanical Footwear for Knee Osteoarthritis. Some studies report that it can help reduce knee pain, but they also emphasize the need for more research to confirm these findings. One study found that using specialized footwear for six months could improve knee function by reducing stress on the knee. However, the benefits of this therapy are still unclear, and the high cost of around $5,000 makes it a less attractive option without stronger evidence. Compared to other treatments, the evidence for Biomechanical Footwear is not strong enough to recommend it as a routine option for knee osteoarthritis. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment AposHealth Biomechanical Footwear for knee osteoarthritis?

Some studies suggest that biomechanical footwear may help reduce knee pain and improve physical function in people with knee osteoarthritis, but the evidence is not strong enough to confirm its long-term effectiveness and safety. Further research is needed to determine its true clinical value. ^{1 2 3 4 5}

What safety data exists for biomechanical footwear in treating knee osteoarthritis?

The available research on biomechanical footwear for knee osteoarthritis suggests potential benefits in pain alleviation, but the evidence is weak and further investigation is needed to confirm its long-term effectiveness and safety. The BIOTOK Randomized Clinical Trial indicates possible improvements in pain and physical function, but the benefits remain unclear. Overall, there is a lack of conclusive safety data, and more studies are required to establish the treatment's safety profile. ^{1 3 4 6 7}

Is biomechanical footwear safe for humans?

The safety of biomechanical footwear for knee osteoarthritis is not well-established, as studies suggest more research is needed to evaluate its long-term safety and effectiveness. ^{1 3 4 6 7}

Is AposHealth a promising treatment for knee osteoarthritis?

AposHealth, a type of biomechanical footwear, shows potential in reducing knee pain and improving function for people with knee osteoarthritis. Some studies suggest it can help by decreasing the load on the knee, which might slow down the disease and reduce pain. However, more research is needed to confirm its long-term effectiveness and safety. ^{1 3 4 8 9}

How is AposHealth Biomechanical Footwear different from other treatments for knee osteoarthritis?

AposHealth Biomechanical Footwear is unique because it aims to reduce knee pain and slow disease progression by decreasing knee loading through specialized footwear, rather than using medication or invasive procedures. However, its long-term effectiveness and safety are still uncertain, and it is relatively expensive. ^{1 3 4 8 9}

What is the purpose of this trial?

Osteoarthritis (OA), the most common type of arthritis, affects more than 32.5 million adults in the United States. It is also among the most expensive condition to treat when joint replacement surgery is required. Although biomechanics plays an important role in OA disease, the non-surgical treatment options addressing biomechanics are scarce with limited effect. AposHealth is the fist biomechanical treatment that was shown to have a significant short-term effect on patients with knee OA. The main objectives of this study are: 1. To assess AposHealth, a non-invasive home-based biomechanical treatment, as an alternative treatment for patients who are eligible for Total Knee Replacement (TKR). 2. To assess AposHealth as a new post-operative rehabilitation tool for patients post TKR.

Research Team

Michael Suk, MD

Principal Investigator

Geisinger Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. Iran pubmed.ncbi.nlm.nih.gov

The Effect of Biomechanical Footwear on Pain from Knee Osteoarthritis. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of footwear on the external knee adduction moment - A systematic review. [2022]

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

Improvement in knee loading after use of specialized footwear for knee osteoarthritis: results of a six-month pilot investigation. [2013]

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

Effect of Biomechanical Footwear on Knee Pain in People With Knee Osteoarthritis: The BIOTOK Randomized Clinical Trial. [2023]

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

Positive outcomes following gait therapy intervention for hip osteoarthritis: A longitudinal study. [2017]

6. England pubmed.ncbi.nlm.nih.gov

Self-reported adult footwear and the risks of lower limb osteoarthritis: the GOAL case control study. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Measurement and reporting of footwear characteristics in running biomechanics: A systematic search and narrative synthesis of contemporary research methods. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Effect of biomechanical footwear on upper and lower leg muscle activity in comparison with knee brace and normal walking. [2021]

9. England 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. [2022]