Actively Recruiting
Biomechanical Footwear as a Non-invasive Alternative and Supplement to Total Knee Replacement
Led by Geisinger Clinic · Updated on 2025-04-30
150
Participants Needed
2
Research Sites
240 weeks
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), 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.
CONDITIONS
Official 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
- Between ages 45 and 80, inclusive
- Meet ACR clinical criteria for knee osteoarthritis
- Have symptomatic uni- or bilateral knee osteoarthritis for at least six months
- X-rays showing tibiofemoral knee osteoarthritis with Kellgren and Lawrence Grade 2 or higher
- Moderate or higher pain score at baseline (Numerical Pain Rating Scale ≥5)
- Physical status score of 1 to 3 based on the American Society of Anesthesiologists Physical Status Classification
- Able and willing to read, understand, and sign the informed consent in English prior to study participation
You will not qualify if you...
- Body Mass Index (BMI) greater than 40
- History of inflammatory rheumatic disease
- Non-knee musculoskeletal pain more severe than knee pain
- Received corticosteroid injections in knees within the last 6 weeks
- Previous major knee surgery such as osteotomy, hemiprosthesis, or unilateral total joint replacement (excluding knee arthroscopy over 6 months ago)
- Covered by Geisinger Health Plan insurance for Apos treatment
- Recent mental health condition (within last 3 months) such as depression or anxiety
- Balance problems including more than 2 unexplained falls in past 12 months, regular dizziness causing trips or falls, or use of walking aids like rollator, cane, or walker
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
K
Kenneth Sams
CONTACT
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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