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

StatusUnknown
PhaseNot applicable
Started

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.

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Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Primary and study completion dates: Mar 2025 to Mar 2026v8
  3. Primary and study completion dates: Dec 2024 to Mar 2025
    • Collaborator revised
    v7
  4. Re-verified, no change to tracked fieldsv6
  5. Primary and study completion dates: Dec 2022 to Dec 2024
    • Site contacts updated at 2 of 2 sites
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 2021 to Jul 22, 2021
    • Site details revised at 2 of 2 sites
    v4
  2. Lead sponsor: Michael Suk, MD, JD, MPH, MBA, FACS to Geisinger Clinicv3 Show 6 more changesShow less
    • Start date: Mar 2021 to Aug 2021
    • Primary and study completion dates: Oct 2022 to Dec 2022
    • Interventions: AposTherapy (Device), Total Knee Replacement (TKR) (Procedure) to AposHealth (Device), Total Knee Replacement (TKR) (Procedure)
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: 11 to 10
    • Study description revised
  3. Secondary endpoints: 9 to 11
    • Collaborator revised
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04732962
Lead Sponsor Geisinger Clinic
Collaborators: Apos Medical and Sports Technology Ltd.
Conditions
(from sponsor)		 Osteoarthritis, Knee
Related terms Osteoarthritis, Knee
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov