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CompletedNCT01574833Updated Apr 10, 2012

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

A Phase 4 interventional study of pulsed electromagnetic field and sham in Fracture and Delayed Union of Fracture, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-04-10.

Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Fracture
  • Delayed Union of Fracture

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03

In context

Fractures, Bone

2,272 studies on the registry are indexed under Fractures, Bone; 321 are open to participants now.

This study's enrollment of 92 is above the median of 68 across 1,490 interventional studies indexed under Fractures, Bone.

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Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 248 studies on the registry; 146 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
92 participants (actual)

Study arms

  • Active comparator
    PEMF

    arm that receive PEMF treatment

    Device: pulsed electromagnetic field

  • Sham comparator
    Sham

    arm that receive sham treatment

    Device: sham

Interventions

  • Devicepulsed electromagnetic field

    PEMF treatment

  • Devicesham

    sham treatment

06

What researchers measure

Primary outcomes

  1. percentage of patient achieving fracture union

    Time frame: 12 months

Secondary outcomes

  1. pain

    Time frame: 12 months

07

Study locations

1 site
  • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
    Nanjing, Jiangsu 210008, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01574833
Responsible party
Jin XIONG (Professor, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School) — Principal investigator
First posted
Apr 10, 2012
Start date
Mar 2007
Primary completion
Oct 2011
Completion
Jan 2012
Last update
Apr 10, 2012

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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