Efficacy of AposTherapy® in Knee OA

NYU Langone Health

Status

Terminated

Conditions

Osteoarthritis, Knee

Treatments

Device: Calibrated AposTherapy®

Device: Non-Calibrated Sham Apos Therapy Device

Study type

Interventional

Funder types

Other

Identifiers

NCT03153956

14-02127

Details and patient eligibility

About

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).

Enrollment

77 patients

Sex

All

Ages

45 to 75 years old

Volunteers

No Healthy Volunteers

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