Biomechanical Footwear as a Non-invasive Alternative and Supplement to Total Knee Replacement
ConditionOsteoarthritis, Knee
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
AposHealth
DeviceAposHealth is comprised of a unique footwear (Apos device) and uses two convex pods called "Pertupods", which are screwed into the plantar surface of the sole so that a person walks on these pods. A trained Apos therapist calibrates the devices. The location of the pods is adjusted according to the treatment methodology, depending on the needed effect on unloading the knee and with the purpose of potentially alleviating pain immediately.
Total Knee Replacement (TKR)
Procedure/SurgeryA total knee replacement occurs when a diseased or damaged knee joint is totally replaced with an artificial joint called an implant. The implant consists of high-grade metal and plastic components that fuse to the resurfaced bone. It is designed to move like a healthy human joint.
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: AposHealthExperimental treatment 1 intervention
Group B: Total Knee Replacement (TKR)Active comparator 1 intervention
Group C: Post TKR traditional physical therapy (PT) and AposHealthExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
pain: Numerical Pain Rating Scale
score range: worst 0 - 10 best
Time frame
12 monthsSecondary outcomes
1
Veterans RAND 12 Health Survey (VR-12) physical component score
patient's overall perspective of their physical health; worst 15 - 63 best
Time frame
3, 6, and 12 months2
Koos Jr
short form of knee injury and osteoarthritis outcome questionnaire; worst 0 - 100 best
Time frame
3, 6, and 12 months3
pain: Numerical Pain Rating Scale
score range: worst 0 - 10 best
Time frame
3 and 6 months4
Step length (left and right)
A computerized mat is used to measure spatiotemporal gait parameters (ProtoKinetics Zeno™ Walkway Gait Analysis System). The gait mat detects pressure data during gait, during balance, and additional movement protocols. During the gait test, all patients are asked to walk barefoot at a self-selected speed. Patients walk 3 meters before and after the walkway mat to allow sufficient acceleration and deceleration time outside the measurement area. Each gait test included 6 walks and the mean value of the 6 walks is calculated for step length (in centimeters).
Time frame
6 and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Geisinger Clinic
Lead sponsor
Apos Medical and Sports Technology Ltd.
Collaborator
Source ClinicalTrials.gov