Efficacy of AposTherapy® in Knee OA

Recruitment & Eligibility

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

Study & Design

Arm && Interventions

Group	Intervention	Description
Active Treatment Arm	Calibrated AposTherapy®	Personally calibrated bio-mechanical device
Control Arm	Non-Calibrated Sham Apos Therapy Device	sham-placebo device (similar shoes without bio-mechanical elements).

Primary Outcome Measures

Name	Time	Method
Western Ontario and McMaster University (WOMAC) Total Score	screening, 3 months, 6 months, 9 months, and 12 months	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.

Secondary Outcome Measures

Name	Time	Method
Short-Form 36 (SF-36) Total Score	screening, 3 months, 6 months, 9 months, and 12 months	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.
Visual Analog Score (VAS) Score	12 Months	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.

Recruitment & Eligibility