Biomechanical Footwear as a Non-invasive Alternative and Supplement to Total Knee Replacement
Recruiting · NCT04732962 · Interventional (participants receive a specific treatment) · Lead sponsor: Geisinger Clinic
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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)
Where it is running
2 locations listed across 1 US state.
- Geisinger Medical Center - Danville, Pennsylvania, United States
- Geisinger - Orthopaedics Wilkes-Barre - Wilkes-Barre, Pennsylvania, United States