Efficacy of AposTherapy® in Knee OA



Status:Completed
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:45 - 75
Updated:3/15/2019
Start Date:April 16, 2015
End Date:December 7, 2018

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

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).


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
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