Efficacy of AposTherapy® in Knee OA

Study Overview
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Brief Summary
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A prospective, interventional, randomized, double-arm clinical evaluation study to examine the efficacy of AposTherapy® versus a control group, in the short-term at 6 months and in the long-term at 12 months post-treatment, with the primary efficacy assessment based on improvement in knee pain score and improvement in function in patients following diagnosis of knee osteoarthritis (OA).

Official Title
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A Prospective, Randomized Double-Armed Efficacy Evaluation of AposTherapy® for the Treatment of Knee Osteoarthritis

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: Calibrated AposTherapy®
* Device: Non-Calibrated Sham Apos Therapy Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients suffering from symptomatic unilateral or bilateral knee OA at the medial compartment for at least six months; Fulfilling the ACR clinical criteria; Having radiographically assessed OA of the knee with a Kellgren-Lawrence grade more than or equal to grade 2; and, Having VAS-Pain ≥ 3, on a scale between 0-10. Patients who have a shoe size between US 4 and US 12 Exclusion Criteria: Patients suffering from acute septic arthritis. Patients who received a corticosteroid injection within 3 months of the study. Patients who received hyaluronic acid (HA) injections within 6 months of the study Patients suffering from avascular necrosis of the knee. Patients with a history of knee buckling or recent knee injury. Patients who have had a joint replacement or other major surgery to the knee, hip or ankle (ipsilateral or contralateral side). Patients suffering from neuropathic arthropathy. Patients with an increased tendency to fall. Patients exhibiting a lack of physical or mental ability to perform or comply with the study procedure. Patients with a history of pathological osteoporotic fracture. Patients suffering from symptomatic degenerative arthritis in lower limb joints other than the knees. Patients with referred pain in the knees from primary back or hip joint pain. Patients with neurological deficits to the lower extremity (ex. foot drop) Patients whose shoe size is less than US 4 and greater than US 12 Patients who have had arthroscopy within 6 months of the study Patients with inflammatory arthropathy

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Phase I - A prospective, interventional, randomized, double-arm clinical evaluation of patients who have been diagnosed with OA of the knee. The active treatment arm (personally calibrated biomechanical device) will be compared to a control arm (sham-placebo device) (similar shoes without biomechanical elements). Phase II - Open-label, cross-over study design. After the completion of phase one patients will be un-blinded to their group allocation. Patients that were allocated to the sham-placebo control group will cross to the active group and will receive the AposTherapy treatment. Patients that were allocated to the active group will continue with treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Treatment Arm<br>Personally calibrated bio-mechanical device | Device: Calibrated AposTherapy®<br>* a biomechanical device including 2 hemispheric biomechanical elements attached to a platform in a form of a shoe. the biomechanical device is calibrated to each patient by a physiotherapist specialized with the treatment methodology.<br>|
| Placebo Comparator: Control Arm<br>sham-placebo device (similar shoes without bio-mechanical elements). | Device: Non-Calibrated Sham Apos Therapy Device<br>* The comparator group will receive a non-calibrated sham device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster University (WOMAC) Total Score | WOMAC evaluates the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. In this study, WOMAC scores were recomputed as the sum within sub-scales (pain score is the sum of questions 1-5; stiffness is the sum of questions 6-7; functional score is the sum of questions 8-24). The total score is reported as the sum of the pain, stiffness, and functional sub-scores for all participants. The total score range is 0-1292. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. | screening, 3 months, 6 months, 9 months, and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Score (VAS) Score | The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. | 12 Months | 
| Short-Form 36 (SF-36) Total Score | The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The survey consists eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0-100, with lower scores = more disability and higher scores = less disability. Therefore, higher scores represent better health. | screening, 3 months, 6 months, 9 months, and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, AposTherapy® System, Total knee arthroplasties, Degenerative joint disease