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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jin XIONG, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier:
NCT01574833
First received: April 7, 2012
Last updated: April 9, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Fracture
Delayed Union of Fracture
Device: pulsed electromagnetic field
Device: sham
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:

Primary Outcome Measures:
  • percentage of patient achieving fracture union [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pain [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 92
Study Start Date: March 2007
Study Completion Date: January 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01574833

Locations
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

No publications provided

Responsible Party: Jin XIONG, Professor, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier: NCT01574833     History of Changes
Other Study ID Numbers: QYK10147
Study First Received: April 7, 2012
Last Updated: April 9, 2012
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Fractures, Bone
Fractures, Ununited
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014