Actively Recruiting
The Effect of Biomechanical Footwear as a Non-invasive Alternative to Total Knee Replacement and as a Rehabilitation Aid After Surgery
Led by Geisinger Clinic · Updated on 2025-04-30
150
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
G
Geisinger Clinic
Lead Sponsor
A
Apos Medical and Sports Technology Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Osteoarthritis (OA) of the knee is a common and costly condition that affects millions of adults, often leading to the need for total knee replacement (TKR) surgery. This study evaluates AposHealth, a non-invasive biomechanical footwear treatment, as both an alternative to TKR for eligible patients and as a supplement to traditional rehabilitation after TKR. The study aims to assess whether this home-based treatment can improve patient outcomes and reduce pain associated with knee OA. Participants will receive AposHealth, which involves wearing specially designed footwear with convex pods that are calibrated by a trained therapist to help reduce knee pain by altering biomechanics. Patients will follow a home-based plan, gradually increasing wear time from 20 to 60 minutes daily. Those undergoing TKR will receive standard surgical care, with post-op patients receiving traditional physical therapy combined with AposHealth starting six weeks after surgery and continuing for 12 months. Follow-up visits occur at 1, 3, 6, 9, and 12 months, with remote checks to ensure adherence and device recalibration. Throughout the study, participants will undergo assessments including pain measurement using the Numerical Pain Rating Scale, physical function surveys, gait analysis, and monitoring of pain medication use. Regular clinical evaluations will adjust treatment as needed, with the primary outcome focusing on pain at 12 months. The total study duration and follow-up extend up to one year, allowing researchers to evaluate both short- and longer-term effects of the AposHealth device on knee OA management and recovery after knee replacement.
CONDITIONS
Brief Title
Biomechanical Footwear as a Non-invasive Alternative and Supplement to Total Knee Replacement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or non-pregnant women
- Aged between 45 and 80 years, inclusive
- Meet clinical criteria for knee osteoarthritis
- Have symptomatic uni- or bilateral knee osteoarthritis for at least six months
- X-rays showing tibiofemoral knee osteoarthritis of at least Kellgren and Lawrence Grade 2
- Moderate or higher baseline knee pain score (Numerical Pain Rating Scale 6)
- Physical status classification of 1 to 3 by American Society of Anesthesiologists
- Able and willing to read, understand, and sign informed consent in English
You will not qualify if you...
- Body mass index over 40
- History of inflammatory rheumatic disease
- Non-knee musculoskeletal pain more severe than knee pain
- Corticosteroid injections in knees within the past 6 weeks
- Prior major knee surgery such as osteotomy, hemiprosthesis, or unilateral total joint replacement except knee arthroscopy more than 6 months ago
- Insured by Geisinger Health Plan if Apos is covered
- Recent (within 3 months) mental health conditions like depression or anxiety
- Balance problems including more than 2 unexplained falls in the past year, dizziness causing trips or falls, or need for walking aids like cane, walker, or rollator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive AposHealth biomechanical footwear as a non-invasive home-based treatment. The treatment starts with wearing the device for about 20 minutes with about 20% weight-bearing, gradually increasing to 60 minutes with about 40% weight-bearing. Participants have follow-up appointments to reassess outcomes and adjust the device as needed.
1 initial calibration visit, 1 remote follow-up visit after 1 week, and in-person follow-up visits at 1, 3, 6, 9, and 12 months
Duration - Surgery and recovery period before post-op treatment
Participants who undergo total knee replacement surgery receive the surgical intervention and follow the usual care protocol. The study baseline visit occurs 6 weeks after surgery to begin assessments.
Surgery visit plus 1 baseline visit 6 weeks post-operation
Duration - 12 months post-operative treatment
Participants who have had total knee replacement follow traditional physical therapy and also receive AposHealth treatment starting six weeks after surgery. This includes initial evaluation and device calibration, followed by remote and in-clinic follow-ups to adjust treatment and assess progress.
1 initial evaluation visit, 1 remote follow-up visit after 1 week, and in-person follow-up visits at 1, 3, 6, 9, and 12 months post-op
Trial Site Locations
Total: 2 locations
1
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Actively Recruiting
2
Geisinger - Orthopaedics Wilkes-Barre
Wilkes-Barre, Pennsylvania, United States, 18702
Actively Recruiting
Research Team
M
Michael Suk, MD
K
Kenneth Sams
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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