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RECRUITING
NCT04732962
NA

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

Sponsor: Geisinger Clinic

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

45 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2021-07-22

Completion Date

2026-03

Last Updated

2025-04-30

Healthy Volunteers

No

Interventions

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.

Locations (2)

Geisinger Medical Center

Danville, Pennsylvania, United States

Geisinger - Orthopaedics Wilkes-Barre

Wilkes-Barre, Pennsylvania, United States