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

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ClinicalTrials.gov Identifier: NCT01574833
Recruitment Status : Completed
First Posted : April 10, 2012
Last Update Posted : April 10, 2012
Sponsor:
Information provided by (Responsible Party):
Jin XIONG, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fracture Delayed Union of Fracture Device: pulsed electromagnetic field Device: sham Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Early Applied Pulsed Electromagnetic Field in the Treatment of Postoperative Delayed Union of Long-bone Fractures
Study Start Date : March 2007
Actual Primary Completion Date : October 2011
Actual Study Completion Date : January 2012

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. percentage of patient achieving fracture union [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. pain [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574833


Locations
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China, Jiangsu
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008
Sponsors and Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Jin XIONG, Professor, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier: NCT01574833    
Other Study ID Numbers: QYK10147
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: April 10, 2012
Last Verified: April 2012
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries