RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. 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.

Official Title

The Effect of a Biomechanical Footwear as a Non-invasive Alternative to Total Knee Replacement and as an Additional Rehabilitation Regimen Postoperatively

Quick Facts

Study Start:2021-07-22
Study Completion:2025-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04732962

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men or non-pregnant women
  2. * Between ages 45 and 80, inclusive
  3. * ACR clinical criteria for OA of the knee
  4. * Symptomatic uni- or bilateral OA of the knee for at least six months
  5. * Radiological criteria: X-rays showing tibiofemoral knee osteoarthritis defined as at least Kellgren and Lawrence Grade 2
  6. * At least a moderate NPRS pain score at baseline (≥5)
  7. * Score of 1-3 based on the American Society of Anesthesiologists Physical Status Classification System
  8. * Willing and able to read, comprehend, and sign the study informed consent form in English prior to study specific procedure
  1. * Body Mass Index (BMI) \> 40
  2. * History of an inflammatory rheumatic disease
  3. * Non-knee musculoskeletal pain that is more severe than the knee pain
  4. * Corticosteroids injections in the knees in the previous 6 weeks
  5. * Previous major surgery to the knee such as osteotomy, hemiprosthesis, unilateral total joint replacement excluding knee arthroscopy \> 6 months
  6. * Patients with Geisinger Health Plan insurance for whom Apos is a covered treatment
  7. * Patients with a recent history (\<3 months) of a mental health condition, such as depression or anxiety
  8. * 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)

Contacts and Locations

Study Contact

Michael Suk, MD
CONTACT
570-271-6541
orthoresearch@geisinger.edu
Kenneth Sams
CONTACT
570-214-4806
kbsams@geisinger.edu

Principal Investigator

Michael Suk, MD
PRINCIPAL_INVESTIGATOR
Geisinger Clinic

Study Locations (Sites)

Geisinger Medical Center
Danville, Pennsylvania, 17822
United States
Geisinger - Orthopaedics Wilkes-Barre
Wilkes-Barre, Pennsylvania, 18702
United States

Collaborators and Investigators

Sponsor: Geisinger Clinic

  • Michael Suk, MD, PRINCIPAL_INVESTIGATOR, Geisinger Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-22
Study Completion Date2025-03

Study Record Updates

Study Start Date2021-07-22
Study Completion Date2025-03

Terms related to this study

Additional Relevant MeSH Terms

  • Osteoarthritis, Knee