Status:
RECRUITING
Biomechanical Footwear as a Non-invasive Alternative and Supplement to Total Knee Replacement
Lead Sponsor:
Geisinger Clinic
Collaborating Sponsors:
Apos Medical and Sports Technology Ltd.
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
45-80 years
Phase:
NA
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 surger...
Detailed 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 surger...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04732962
Start Date
July 22 2021
End Date
March 1 2026
Last Update
April 30 2025
Active Locations (2)
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1
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
2
Geisinger - Orthopaedics Wilkes-Barre
Wilkes-Barre, Pennsylvania, United States, 18702