Recruiting

Biomechanical Footwear

Sponsor:

Geisinger Clinic

Code:

NCT04732962

Conditions

Osteoarthritis, Knee

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

AposHealth

Total Knee Replacement (TKR)

Study Details

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.

Conditions

Osteoarthritis, Knee

Study ID

NCT04732962

Start date

Jul 22, 2021

Status verified date

Sep, 2024

Completion date

Mar, 2026

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

150 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AposHealth

Following the initial consultation and calibration of the Apos device in the clinic, the patients will receive from his therapist a home-based treatment plan. This usually includes wearing the device for about 20 minutes with about 20% of weight-bearing (patient is instructed to wear the Apos and just be with the device and go about his/her daily routine). A gradual increase in usage time is prescribed reaching up to 60 min wear time with about 40% weight-bearing.

Patients are requested to return to follow-up (FU) appointments after 1, 3, 6, 9 and 12 months. In addition, patients will have a remote FU after 1-week to confirm they use AposHealth as advised. During the follow-up appointment, re-assessment of clinical outcomes and gait patterns are performed and the calibration of the Apos device is adjusted as needed. The treatment plan is adjusted, and patients are encouraged to continue to wear the device regularly at home.

active comparator: Total Knee Replacement (TKR)

Patients will undergo TKR according to Geisinger's policy, guidelines and care protocol.

The study baseline visit will occur 6 weeks postoperative for TKR groups.

experimental: Post TKR traditional physical therapy (PT) and AposHealth

Patients who have had a knee replacement and were assigned to the traditional PT+ AposHealth group will follow Geisinger post-operative rehab protocol and will also receive AposHealth and follow the rehabilitation protocol.

AposHealth will start six weeks post-op and will continue for 12 months. Patients will receive AposHealth similar to the non-invasive group, i.e., will have an initial evaluation (IE) and calibration of the Apos device, have a remote FU after one week from IE and in-clinic FUs at 1, 3 6, 9 and 12 months.

Interventions

AposHealth

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.

Total 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.

Primary outcome measure

  • pain: Numerical Pain Rating Scale [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Michael Suk, MD

570-271-6541orthoresearch@geisinger.edu

Kenneth Sams

570-214-4806kbsams@geisinger.edu

Locations

Geisinger Medical Center

Recruiting

Danville, Pennsylvania, United States, 17822

Contacts

Kenneth Sams

570-214-4806orthoresearch@geisinger.edu

Geisinger - Orthopaedics Wilkes-Barre

Recruiting

Wilkes-Barre, Pennsylvania, United States, 18702

Contacts

Kenneth Sams

570-214-4806MSKIresearch@geisinger.edu

More Information

Sponsor

Geisinger Clinic

Last update posted

Apr 30, 2025

Last verified

Sep, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Geisinger Clinic on 2025-04-30.