Biomechanical Footwear for Knee Osteoarthritis
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.12345
What data supports the effectiveness of the treatment AposHealth Biomechanical Footwear for knee osteoarthritis?
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.13467
Is biomechanical footwear safe for humans?
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.13489
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.13489
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Initial Evaluation and Calibration
Initial consultation and calibration of the Apos device in the clinic, followed by a home-based treatment plan
Treatment
Participants receive AposHealth treatment, gradually increasing usage time up to 60 minutes with about 40% weight-bearing
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- AposHealth
- Total Knee Replacement (TKR)
AposHealth is already approved in United States, European Union, Canada for the following indications:
- Knee osteoarthritis
- Knee osteoarthritis
- Knee osteoarthritis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Geisinger Clinic
Lead Sponsor
Apos Medical and Sports Technology Ltd.
Industry Sponsor
Apos Medical Assets Ltd. (AMA)
Collaborator