MedTrace Logo

A Double-Blind Study on Adjunctive Use of PEMF in the Treatment of 5th Metatarsal Non-Union Fractures

NCT00586170 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2017-06-21

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to analyze the effect of PEMF in surgical reconstruction of 5th metatarsal non-union fractures.

Conditions

  • Nonunion of Fracture of Fifth Metatarsal

Interventions

DEVICE

EBI Bone Healing System

10 hours of treatment per day for up to 24 weeks

DEVICE

Placebo Device

10 hours of treatment per day for up to 24 weeks

PROCEDURE

Surgery

Open Reduction and Internal Fixation of the nonunion site

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • John Evangelista · Zimmer Biomet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2011-08-31
Completion
2012-08-31

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 NCT00586170 on ClinicalTrials.gov