We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01574833
First Posted: April 10, 2012
Last Update Posted: April 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jin XIONG, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  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
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • percentage of patient achieving fracture union [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • pain [ Time Frame: 12 months ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


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

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
First Submitted: April 7, 2012
First Posted: April 10, 2012
Last Update Posted: April 10, 2012
Last Verified: April 2012

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