Fracture Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 92 |
Est. completion date | January 2012 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | percentage of patient achieving fracture union | 12 months | No | |
Secondary | pain | 12 months | No |
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