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

Geisinger Health

Status: Enrolling

Conditions: Osteoarthritis, Knee

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04732962

2020-0935

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

AposHealth

Experimental group

Description:

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.

Treatment:

Device: AposHealth

Total Knee Replacement (TKR)

Active Comparator group

Description:

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.

Treatment:

Procedure: Total Knee Replacement (TKR)

Post TKR traditional physical therapy (PT) and AposHealth

Experimental group

Description:

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.

Treatment:

Procedure: Total Knee Replacement (TKR)

Device: AposHealth