NCT04732962

Biomechanical Footwear as a Non-invasive Alternative and Supplement to Total Knee Replacement

The Effect of a Biomechanical Footwear as a Non-invasive Alternative to Total Knee Replacement and as an Additional Rehabilitation Regimen Postoperatively

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Geisinger Clinic · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. Future projections of the prevalence of OA predict an increase in prevalence, mainly due to the aging of the population and obesity. Total knee replacement (TKR) is the end-stage solution for patients with knee OA. The total annual cost of arthritis in the U.S. in 2013 reached over $300 billion. Expenditure is expected to grow significantly in response to the increase in prevalence and the projected number of TKRs. Successful and beneficial non-invasive treatment options for knee OA are limited. More specifically, 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 TKR. 2. To assess AposHealth as a new post-operative rehabilitation tool for patients post TKR.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	AposHealth	AposHealth is comprised of a unique footwear (Apos device) and uses two convex pods called "Pertupods", which are screwed into the plantar surface of the sole so that a person walks on these pods. A trained Apos therapist calibrates the devices. The location of the pods is adjusted according to the treatment methodology, depending on the needed effect on unloading the knee and with the purpose of potentially alleviating pain immediately.
PROCEDURE	Total Knee Replacement (TKR)	A total knee replacement occurs when a diseased or damaged knee joint is totally replaced with an artificial joint called an implant. The implant consists of high-grade metal and plastic components that fuse to the resurfaced bone. It is designed to move like a healthy human joint.

Timeline

• Start date: 2021-07-22
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2021-02-01
• Last updated: 2025-04-30

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study