Clinical Trial

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

Recruiting
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Record status
This record was last updated April 30, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2021-01-29; most recent amendment 2025-04-28.
Status change: Not Yet Recruiting → Recruiting 2021-11-04
Trial Details
NCT Number NCT04732962
Lead Sponsor Geisinger Clinic
Collaborators: Apos Medical and Sports Technology Ltd.
Conditions Osteoarthritis, Knee
Enrollment 150 participants
Start Date 2021-07-22
Primary Completion 2026-03 (estimated)
Study Completion 2026-03 (estimated)
Updated on ClinicalTrials.gov 2025-04-30