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

NCT ID: NCT04732962

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-22
• Study Completion Date: 2026-03-31

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.

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

AposHealth

Intervention Type: DEVICE

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)

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.

Group Type: ACTIVE_COMPARATOR

Total Knee Replacement (TKR)

Intervention Type: PROCEDURE

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.

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.

Group Type: EXPERIMENTAL

AposHealth

Intervention Type: DEVICE

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)

Intervention Type: PROCEDURE

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.

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.

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

Eligibility 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)

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Apos Medical and Sports Technology Ltd.

INDUSTRY

Sponsor Role: collaborator

Geisinger Clinic

OTHER

Sponsor Role: lead

Responsible Party

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

Professor and Chair, Musculoskeletal Institute & Department of Orthopaedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Suk, MD

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Locations

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status: RECRUITING

Geisinger - Orthopaedics Wilkes-Barre

Wilkes-Barre, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michael Suk, MD

Role: CONTACT

orthoresearch@geisinger.edu

570-271-6541

Kenneth Sams

Role: CONTACT

kbsams@geisinger.edu

570-214-4806

Facility Contacts

Kenneth Sams

Role: primary

orthoresearch@geisinger.edu

570-214-4806

Kenneth Sams

Role: primary

MSKIresearch@geisinger.edu

570-214-4806

Other Identifiers

2020-0935

Identifier Type: -

Identifier Source: org_study_id