Early Application of Pulsed Electromagnetic Field in the Treatment of Postoperative Delayed Union

April 9, 2012 updated by: Jin XIONG, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Phase 4 Study of Early Applied Pulsed Electromagnetic Field in the Treatment of Postoperative Delayed Union of Long-bone Fractures

The investigators hypothesized that early applied pulsed electromagnetic field treatment on delayed union might lead to increased rate of fracture union and shortened period of treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 4

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

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The failure of healing after at least 16 weeks and not more than 9 months following surgical reduction and fixation of the fracture.

Exclusion Criteria:

  • Implant loosening or failure, infection, established nonunion, fracture gap greater than 5 mm, presence of implant within the fracture gap, metabolic disorders or received medication affecting fracture healing

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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PEMF
arm that receive PEMF treatment
Device: pulsed electromagnetic field
PEMF treatment
Sham Comparator: Sham
arm that receive sham treatment
Device: sham
sham treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
percentage of patient achieving fracture union
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
pain
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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

March 1, 2007

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

April 7, 2012

First Submitted That Met QC Criteria

April 9, 2012

First Posted (Estimate)

April 10, 2012

Study Record Updates

Last Update Posted (Estimate)

April 10, 2012

Last Update Submitted That Met QC Criteria

April 9, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QYK10147

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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