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

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 |
- percentage of patient achieving fracture union [ Time Frame: 12 months ]
- pain [ Time Frame: 12 months ]

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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 |
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

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
China, Jiangsu | |
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School | |
Nanjing, Jiangsu, China, 210008 |
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 |
Fractures, Bone Wounds and Injuries |