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NCT01574833 Clinical Trial

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

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01574833
Other study ID # QYK10147
Secondary ID
Status Completed
Phase Phase 4
First received April 7, 2012
Last updated April 9, 2012
Start date March 2007
Est. completion date January 2012

Study information
Verified date April 2012
Source The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• pulsed electromagnetic field
PEMF treatment
• sham
sham treatment

Locations
Country Name City State
China Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School Nanjing Jiangsu

Sponsors (1)
Lead Sponsor Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome
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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