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NCT04732962 | RECRUITING | Osteoarthritis, Knee

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

Geisinger Clinic

Information provided by (Responsible Party):

Michael Suk, MD, JD, MPH, MBA, FACS

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.

Condition or disease

Osteoarthritis, Knee

Intervention/treatment

AposHealth

Total Knee Replacement (TKR)

Phase

NA

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 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 and the projected number of TKRs. Successful and beneficial non-invasive treatment options for knee OA are limited. More specifically, 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 TKR. 2. To assess AposHealth as a new post-operative rehabilitation tool for patients post TKR.

Study Type : INTERVENTIONAL
Estimated Enrollment : 150 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : The Effect of a Biomechanical Footwear as a Non-invasive Alternative to Total Knee Replacement and as an Additional Rehabilitation Regimen Postoperatively
Actual Study Start Date : 2021-07-22
Estimated Primary Completion Date : 2025-03
Estimated Study Completion Date : 2025-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 45 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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)
Biomechanical Footwear as a Non-invasive Alternative and Supplement to Total Knee Replacement

Location Details

NCT04732962

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How to Participate

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Locations

RECRUITING

United States, Pennsylvania

Geisinger Medical Center

Danville, Pennsylvania, United States, 17822

RECRUITING

United States, Pennsylvania

Geisinger - Orthopaedics Wilkes-Barre

Wilkes-Barre, Pennsylvania, United States, 18702