AposHealth for Knee Osteoarthritis as an Alternative or Supplement to Total Knee Replacement

This study is looking at AposHealth, a special type of footwear with unique pods, for people aged 45 to 80 with knee osteoarthritis (OA). OA is a common type of arthritis where the knee joint wears down. AposHealth is designed to be a non-surgical option for those who might otherwise need a total knee replacement (TKR), or as a rehabilitation tool after TKR surgery. The main goal is to see if AposHealth can reduce pain, measured by a pain rating scale, over 12 months. You could be eligible if you have symptomatic knee OA that shows on X-rays and a moderate pain score.

Study design
This interventional study plans to enroll 150 participants. It is testing AposHealth footwear against total knee replacement surgery.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your pain levels will be measured at 12 months after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04732962

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

Recruiting
NAAges 45–80InterventionalTreatment
Geisinger Clinic
~150 participants
Updated 2025-04-30 on ClinicalTrials.gov
What's tested:AposHealthTotal Knee Replacement (TKR)

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
pain: Numerical Pain Rating Scale
Measured over 12 months
Osteoarthritis, Knee
2 sites across 1 states
Pennsylvania2
  • Michael Suk, MD · PRINCIPAL_INVESTIGATOR · Geisinger Clinic

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Eligibility criteria

Inclusion

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

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)
  • pain: Numerical Pain Rating Scale12 months

    score range: worst 0 - 10 best