MedTrace Logo

Efficacy of AposTherapy® in Knee OA

NCT03153956 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2020-03-24

Study results available
· View outcomes & findings →

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

Interventions

DEVICE

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.

DEVICE

Non-Calibrated Sham Apos Therapy Device

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

Sponsors & Collaborators

Principal Investigators

  • Dennis Cardone, DO · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-16
Primary Completion
2018-11-15
Completion
2018-11-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03153956 on ClinicalTrials.gov