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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-80
SponsorGeisinger Clinic

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • AposHealth
  • Total Knee Replacement (TKR)

Treatment groups

150 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Geisinger Clinic

Lead sponsor

Apos Medical and Sports Technology Ltd.

Collaborator