MedTrace Logo

Efficacy and Safety of an Active Pulsed Electromagnetic Field for the Treatment of Osteoarthritis of the Knee

NCT02436590 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2020-07-14

No results posted yet for this study

Summary

The hypothesis of this study is that exposure to PEMF alters the cytokine environment of OA joints associated with a reduction of inflammation and improved homeostasis of the extracellular matrix (ECM), both potentially effecting symptomatic relief of OA pain, reducing cartilage breakdown, stimulate new cartilage formation therefore preserving joint structure.

Conditions

  • Osteoarthritis, Knee

Interventions

DEVICE

Orthofix Physio-Stim Model 3315OA

Active device emits PEMF signal; placebo/control device does not emit PEMF signal

Sponsors & Collaborators

  • Orthofix Inc.

    lead INDUSTRY

Principal Investigators

  • Roy K Aaron, MD · Warren Alpert Medical School of Medicine, Brown University, Providence, Rhode Island

  • Ronald Delanois, MD · Rubin Institute for Advance Orthopedics, Sinai Hospital of Baltimore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2019-09-30
Completion
2019-09-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT02436590 on ClinicalTrials.gov