Back to resultsEarly Application of Pulsed Electromagnetic Field in the Treatment of Postoperative Delayed Union
Primary Purpose
Fracture, Delayed Union of Fracture
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
pulsed electromagnetic field
sham
Sponsored by
About this trial
This is an interventional treatment trial for Fracture
Eligibility 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
Sites / Locations
- Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
PEMF
Sham
Arm Description
arm that receive PEMF treatment
arm that receive sham treatment
Outcomes
Primary Outcome Measures
percentage of patient achieving fracture union
Secondary Outcome Measures
pain
Full Information
NCT ID
NCT01574833
First Posted
April 7, 2012
Last Updated
April 9, 2012
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
1. Study Identification
Unique Protocol Identification Number
NCT01574833
Brief Title
Early Application of Pulsed Electromagnetic Field in the Treatment of Postoperative Delayed Union
Official Title
Phase 4 Study of Early Applied Pulsed Electromagnetic Field in the Treatment of Postoperative Delayed Union of Long-bone Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture, Delayed Union of Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PEMF
Arm Type
Active Comparator
Arm Description
arm that receive PEMF treatment
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
arm that receive sham treatment
Intervention Type
Device
Intervention Name(s)
pulsed electromagnetic field
Intervention Description
PEMF treatment
Intervention Type
Device
Intervention Name(s)
sham
Intervention Description
sham treatment
Primary Outcome Measure Information:
Title
percentage of patient achieving fracture union
Time Frame
12 months
Secondary Outcome Measure Information:
Title
pain
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
12. IPD Sharing Statement
Learn more about this trial
Early Application of Pulsed Electromagnetic Field in the Treatment of Postoperative Delayed Union
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