Efficacy of AposTherapy® in Knee OA

NCT ID: NCT03153956

Last Updated: 2020-03-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-16
• Study Completion Date: 2018-11-15

Brief Summary

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).

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active Treatment Arm

Personally calibrated bio-mechanical device

Group Type: EXPERIMENTAL

Calibrated AposTherapy®

Intervention Type: DEVICE

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.

Control Arm

sham-placebo device (similar shoes without bio-mechanical elements).

Group Type: PLACEBO_COMPARATOR

Non-Calibrated Sham Apos Therapy Device

Intervention Type: DEVICE

The comparator group will receive a non-calibrated sham device.

Interventions

Calibrated AposTherapy®

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.

Intervention Type: DEVICE

Non-Calibrated Sham Apos Therapy Device

The comparator group will receive a non-calibrated sham device.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dennis Cardone, DO

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

14-02127

Identifier Type: -

Identifier Source: org_study_id