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

Osteoarthritis, Knee Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Osteoarthritis, Knee

• NCT number: NCT04732962
• Study type: Interventional
• Source: Geisinger Clinic
• Contact: Michael Suk, MD
• Phone: 570-271-6541
• Email: orthoresearch@geisinger.edu
• Status: Recruiting
• Phase: N/A
• Start date: July 22, 2021
• Completion date: March 2025