NCT04732962 Biomechanical Footwear as a Non-invasive Alternative and Supplement to Total Knee Replacement
| NCT ID | NCT04732962 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Geisinger Clinic |
| Condition | Osteoarthritis, Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2021-07-22 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2021-07-22 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Men or non-pregnant women * Between ages 45 and 80, inclusive * ACR clinical criteria for OA of the knee * Symptomatic uni- or bilateral OA of the knee for at least six months * Radiological criteria: X-rays showing tibiofemoral knee osteoarthritis defined as at least Kellgren and Lawrence Grade 2 * At least a moderate NPRS pain score at baseline (≥5) * Score of 1-3 based on the American Society of Anesthesiologists Physical Status Classification System * Willing and able to read, comprehend, and sign the study informed consent form in English prior to study specific procedure Exclusion Criteria: * Body Mass Index (BMI) \> 40 * History of an inflammatory rheumatic disease * Non-knee musculoskeletal pain that is more severe than the knee pain * Corticosteroids injections in the knees in the previous 6 weeks * Previous major surgery to the knee such as osteotomy, hemiprosthesis, unilateral total joint replacement excluding knee arthroscopy \> 6 months * Patients with Geisinger Health Plan insurance for whom Apos is a covered treatment * Patients with a recent history (\<3 months) of a mental health condition, such as depression or anxiety * Problems with balance (\>2 unexplained falls within the last 12 months; experiencing regular dizziness that has caused a trip or fall; using a walking aid to get around such as a rollator, cane, walker)
Contact & Investigator
Michael Suk, MD
PRINCIPAL INVESTIGATOR
Geisinger Clinic
Frequently Asked Questions
Who can join the NCT04732962 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 80 Years, studying Osteoarthritis, Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04732962 currently recruiting?
Yes, NCT04732962 is actively recruiting participants. Contact the research team at orthoresearch@geisinger.edu for enrollment information.
Where is the NCT04732962 trial being conducted?
This trial is being conducted at Danville, United States, Wilkes-Barre, United States.
Who is sponsoring the NCT04732962 clinical trial?
NCT04732962 is sponsored by Geisinger Clinic. The principal investigator is Michael Suk, MD at Geisinger Clinic. The trial plans to enroll 150 participants.