Efficacy of AposTherapy® in Knee OA

Stopped early · Not applicable · Has a placebo group

Conditions studied: Osteoarthritis, Knee

In brief

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).

Key facts

Study ID

NCT03153956

Run by

NYU Langone Health

People needed

77

Starts

2015-04-16

Expected to finish

2018-11-15

Last updated by the study team

2020-03-24

Who can join

Age: 45 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• New York University School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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