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

NCT04732962 | Recruiting FDA Device

• 1 other identifier: 2020-0935
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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. 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. 2.To assess AposHealth as a new post-operative rehabilitation tool for patients post TKR.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• pain: Numerical Pain Rating Scale

  score range: worst 0 - 10 best

  12 months

Secondary Outcomes (10)

• Veterans RAND 12 Health Survey (VR-12) physical component score

  3, 6, and 12 months

• Koos Jr

  3, 6, and 12 months

• pain: Numerical Pain Rating Scale

  3 and 6 months

• Step length (left and right)

  6 and 12 months

• Single limb support (SLS): % gait cycle (left and right)

  6 and 12 months

Study Arms (3)

AposHealth

EXPERIMENTAL

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.

Device: AposHealth

Total Knee Replacement (TKR)

ACTIVE COMPARATOR

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.

Procedure: Total Knee Replacement (TKR)

Post TKR traditional physical therapy (PT) and AposHealth

EXPERIMENTAL

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.

Device: AposHealth; Procedure: Total Knee Replacement (TKR)

Interventions

AposHealth 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.

AposHealth; Post TKR traditional physical therapy (PT) and AposHealth

Total Knee Replacement (TKR) 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; Total Knee Replacement (TKR)

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Geisinger Clinic: lead
• Apos Medical and Sports Technology Ltd.: collaborator

Study Sites (2)

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

RECRUITING

Geisinger - Orthopaedics Wilkes-Barre

Wilkes-Barre, Pennsylvania, 18702, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Michael Suk, MD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Suk, MD

CONTACT

570-271-6541; orthoresearch@geisinger.edu

Kenneth Sams

CONTACT

570-214-4806; kbsams@geisinger.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair, Musculoskeletal Institute & Department of Orthopaedic Surgery

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 1, 2021
• Study Start: July 22, 2021
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 30, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)