The Effect of a Biomechanical Footwear as a Non-invasive Alternative to Total Knee Replacement and as an Additional Rehabilitation Regimen Postoperatively
Geisinger Clinic
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.
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 surgery is required. Future projections of the prevalence of OA predict an increase in prevalence, mainly due to the aging of the population and obesity. Total knee replacement (TKR) is the end-stage solution for patients with knee OA. The total annual cost of arthritis in the U.S. in 2013 reached over $300 billion. Expenditure is expected to grow significantly in response to the increase in prevalence…
Eligibility
- Age range
- 45–80 years
- Sex
- All
- Healthy volunteers
- No
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 pro…
Interventions
- DeviceAposHealth
AposHealth is comprised of a unique footwear (Apos device) and uses two convex pods called "Pertupods", which are screwed into the plantar surface of the sole so that a person walks on these pods. A trained Apos therapist calibrates the devices. The location of the pods is adjusted according to the treatment methodology, depending on the needed effect on unloading the knee and with the purpose of potentially alleviating pain immediately.
- ProcedureTotal Knee Replacement (TKR)
A total knee replacement occurs when a diseased or damaged knee joint is totally replaced with an artificial joint called an implant. The implant consists of high-grade metal and plastic components that fuse to the resurfaced bone. It is designed to move like a healthy human joint.
Locations (2)
- Geisinger Medical CenterDanville, Pennsylvania
- Geisinger - Orthopaedics Wilkes-BarreWilkes-Barre, Pennsylvania