Biomechanical footwear as an alternative to knee replacement

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

This study is testing a new home-based treatment for knee osteoarthritis to see if it can help people avoid knee replacement surgery and improve their recovery after surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 45 Years to 80 Years
• Sex: All
• Sponsor: Geisinger Clinic (Academic / other)
• Locations: 2 sites (Danville, Pennsylvania and 1 other locations)
• Trial ID: NCT04732962 on ClinicalTrials.gov

What this trial studies

This study evaluates AposHealth, a non-invasive home-based biomechanical treatment, as an alternative for patients with knee osteoarthritis who are eligible for total knee replacement. It aims to assess the effectiveness of AposHealth not only as a pre-operative treatment but also as a rehabilitation tool for patients recovering from knee replacement surgery. The study focuses on patients suffering from symptomatic knee osteoarthritis and seeks to provide a viable non-surgical option to alleviate pain and improve function. Participants will be monitored for their response to the treatment over a specified period.

Who should consider this trial

Good fit: Ideal candidates are men and non-pregnant women aged 45 to 80 with symptomatic knee osteoarthritis who have not responded adequately to other treatments.

Not a fit: Patients with a Body Mass Index over 40 or those with severe non-knee musculoskeletal pain may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a non-invasive alternative to total knee replacement, reducing the need for surgery and associated costs.

How similar studies have performed: While the approach of using biomechanical treatments is relatively novel, previous studies have shown promising results with similar non-invasive interventions for knee osteoarthritis.

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)

Where this trial is running

Danville, Pennsylvania and 1 other locations

• Geisinger Medical Center — Danville, Pennsylvania, United States (Recruiting)
• Geisinger - Orthopaedics Wilkes-Barre — Wilkes-Barre, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Michael Suk, MD — Geisinger Clinic
• Study coordinator: Michael Suk, MD

Conditions Osteoarthritis, Knee