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

June 19, 2017 updated by: Zimmer Biomet

A Prospective, Randomized, Double-Blind Study on Adjunctive Use of Pulsed Electromagnetic Fields in the Treatment of 5th Metatarsal Non-Union Fractures: Effect on Clinical Outcome and Growth Factor Synthesis

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The investigators hypothesize:

  1. That treatment of 5th metatarsal non-union fracture with PEMF will achieve earlier resolution and/or higher success compared to surgery alone of 5th metatarsal non-union fractures.
  2. PEMF will stimulate increased expression of critical growth factors (i.e. BMP-2, BMP-4, BMP-7 as well as TGFb, IGF-1, FGF-2 and VEGF) at the non-union site to facilitate osseous healing of 5th metatarsal non-union fractures.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Neurological Institute of NJ
    • Ohio
      • Columbus, Ohio, United States, 43231
        • The Orthopedic Foot and Ankle Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject has been diagnosed with a 5th metatarsal delayed or non-union.
  2. Subjects with duration of a 5th metatarsal fracture for a minimum of 3 months.
  3. Male or female between ages of 18 and 75 years old, inclusive

Exclusion Criteria:

  1. Subject has synovial pseudarthrosis.
  2. Subject has a fracture gap of larger than 5mm as measured on CT Scan.
  3. Subjects with conditions associated with elevated circulatory levels of inflammatory cytokines e.g., multiple trauma.
  4. If female, subject is pregnant, plans on becoming pregnant during the duration of this clinical outcomes collection study or lactating.
  5. Subject has an implanted unipolar pacemaker.
  6. Subjects who have previous malignant or connective tissue disorder.
  7. Subjects who use medication such as steroids or anticoagulants.
  8. Subjects who have an underlying osseous infection (Osteomyelitis) and/or open wound.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: EBI Bone Healing System + Surgery
Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.
Device: EBI Bone Healing System
10 hours of treatment per day for up to 24 weeks
Procedure: Surgery
Open Reduction and Internal Fixation of the nonunion site
PLACEBO_COMPARATOR: Placebo Device + Surgery
Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.
Procedure: Surgery
Open Reduction and Internal Fixation of the nonunion site
Device: Placebo Device
10 hours of treatment per day for up to 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Successful 5th Metatarsal Unions Achieved.
Time Frame: 24 Weeks
Each patient was assessed radiographically at 2, 4, 6, 8, 12, 16, 20, and 24 weeks or until radiographic signs of healing were evident. The radiographs were evaluated and graded by the number of cortices (medial and lateral on anteroposterior views as well as dorsal and plantar on lateral views) of healing at each time point. Bridging callus across 4 cortices on postoperative radiographs was used to determine healing.
24 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean AOFAS Score (% Change From Baseline), Foot Function Index (% Change From Baseline), SF-36 Health Survey (Change From Baseline)
Time Frame: 24 Weeks
24 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Investigators

  • Study Director: John Evangelista, Zimmer Biomet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (ESTIMATE)

January 4, 2008

Study Record Updates

Last Update Posted (ACTUAL)

June 21, 2017

Last Update Submitted That Met QC Criteria

June 19, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS-027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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