Biomechanical Footwear for Knee Osteoarthritis
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Geisinger Clinic
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
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.
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.
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.
23678What 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.
34689What 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.
13568Eligibility 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
My pain level is at least moderate, scoring 5 or more.
I have had knee pain from arthritis for at least 6 months.
My knee X-rays show I have moderate arthritis.
I am between 45 and 80 years old.
Exclusion Criteria
I have had balance issues, including more than 2 falls, dizziness leading to falls, or I use a walking aid.
My insurance covers Apos treatment.
My pain in areas other than my knee is worse than in my knee.
I have a history of inflammatory rheumatic disease.
Participant Groups
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.
3Treatment groups
Experimental Treatment
Active Control
Group I: Post TKR traditional physical therapy (PT) and AposHealthExperimental Treatment2 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: AposHealthExperimental Treatment1 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 Control1 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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Geisinger Medical CenterDanville, PA
Geisinger - Orthopaedics Wilkes-BarreWilkes-Barre, PA
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Who is running the clinical trial?
Geisinger ClinicLead Sponsor
Apos Medical and Sports Technology Ltd.Industry Sponsor
Apos Medical Assets Ltd. (AMA)Collaborator
References
Effect of footwear on the external knee adduction moment - A systematic review. [2022]Footwear modifications have been investigated as conservative interventions to decrease peak external knee adduction moment (EKAM) and pain associated with knee osteoarthritis (OA).
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]Recent studies have shown an important reduction of joint overload during locomotion in elderly women with knee osteoarthritis (OA) after short-term use of minimalist shoes. Our aim is to investigate the chronic effect of inexpensive and minimalist footwear on the clinical and functional aspects of OA and gait biomechanics of elderly women with knee OA.
Improvement in knee loading after use of specialized footwear for knee osteoarthritis: results of a six-month pilot investigation. [2013]Biomechanical interventions for knee osteoarthritis (OA) aim to improve pain and retard disease progression by decreasing knee loading. This study was undertaken to evaluate the effects of 6 months of use of flat, flexible footwear (the mobility shoe) on knee loading in OA.
Self-reported adult footwear and the risks of lower limb osteoarthritis: the GOAL case control study. [2021]Biomechanical factors may play a role in osteoarthritis (OA) development and progression. Previous biomechanical studies have indicated that types of footwear may modulate forces across the knee joint, and high heeled womens' shoes in particular are hypothesised to be detrimental to lower limb joint health. This analysis of data from a case control study investigated persistent users of different adult footwear for risks of knee and hip OA. Our underlying hypotheses were that high heeled, narrow heeled, and hard soled shoe types were putative risk factors for lower limb OA.
Positive outcomes following gait therapy intervention for hip osteoarthritis: A longitudinal study. [2017]Footwear-generated biomechanical manipulation of lower-limb joints was shown to beneficially impact gait and quality of life in knee osteoarthritis patients, but has not been tested in hip osteoarthritis patients. We examined a customized gait treatment program using a biomechanical device shown in previous investigations to be capable of manipulating hip biomechanics via foot center of pressure (COP) modulation. The objective of this study was to assess the treatment program for hip osteoarthritis patients, enrolled in a 1-year prospective investigation, by means of objective gait and spatiotemporal parameters, and subjective quality of life measures. Gait analysis and completion of questionnaires were performed at the start of the treatment (baseline), and after 3, 6, and 12 months. Outcome parameters were evaluated over time using linear mixed effects models, and association between improvement in quality of life measures and change in objective outcomes was tested using mixed effect linear regression models. Quality of life measures improved compared to baseline, accompanied by increased gait speed and cadence. Sagittal-plane hip joint kinetics, kinematics, and spatiotemporal parameters changed throughout the study compared to baseline, in a manner suggesting improvement of gait. The most substantial improvement occurred within 3 months after treatment initiation, after which improvement approximately plateaued, but was sustained at 12 months. Speed and cadence, as well as several sagittal-plane gait parameters, were significant predictors of improvement in quality of life.
Effect of Biomechanical Footwear on Knee Pain in People With Knee Osteoarthritis: The BIOTOK Randomized Clinical Trial. [2023]Individually calibrated biomechanical footwear therapy may improve pain and physical function in people with symptomatic knee osteoarthritis, but the benefits of this therapy are unclear.
Effect of biomechanical footwear on upper and lower leg muscle activity in comparison with knee brace and normal walking. [2021]To evaluate the activity of knee stabilizing muscles while using custom-made biomechanical footwear (BF) and to compare it when walking barefoot and with a knee brace (Unloader®).
The Effect of Biomechanical Footwear on Pain from Knee Osteoarthritis. [2022]The effect of biomechanical footwear on pain from knee osteoarthritis (OA) is still unclear and controversial. The purpose of this article is to review the literature with the aim of answering the following question: What is the impact of biomechanical footwear on pain from knee OA? A Cochrane Library and PubMed (MEDLINE) search related to the effect of biomechanical footwear on pain from knee OA was performed. Several authors have reported knee pain alleviation in people with knee OA using biomechanical footwear. However, many of them have also stated that further investigation was required to evaluate its long-run effectiveness and safety, as well as replication, prior to reaching conclusions about the clinical value of this treatment. The cost of biomechanical footwear treatment is around 5,000 US dollars. Considering the weak evidence currently available on the efficacy of biomechanical footwear and its high cost, we do not advise the routine use of that treatment until it can be unequivocally confirmed that it is truly effective for pain alleviation in patients with knee OA.
Measurement and reporting of footwear characteristics in running biomechanics: A systematic search and narrative synthesis of contemporary research methods. [2023]This review aimed to synthesise the methods for assessing and reporting footwear characteristics among studies evaluating the effect of footwear on running biomechanics. Electronic searches of Scopus®, EBSCO, PubMed®, ScienceDirect®, and Web of Science® were performed to identify original research articles of the effect of running footwear on running biomechanics published from 1st January 2015 to 7th October 2020. Risk of bias among included studies was not assessed. Results were presented via narrative synthesis. Eligible studies compared the effect of two or more footwear conditions in adult runners on a biomechanical parameter. Eighty-seven articles were included and data from 242 individual footwear were extracted. Predominantly, studies reported footwear taxonomy (i.e., classification) and manufacturer information, however omitted detail regarding the technical specifications of running footwear and did not use validated footwear reporting tools. There is inconsistency among contemporary studies in the methods by which footwear characteristics are assessed and reported. These findings point towards a need for consensus regarding the reporting of these characteristics within biomechanical studies to facilitate the conduct of systematic reviews and meta-analyses pertaining to the effect of running footwear on running biomechanics.