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Completed

NCT Number: NCT01574833

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

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.

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Key information

Conditions

Fracture Delayed Union of Fracture Fractures, Bone Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulsed electromagnetic field

Device

PEMF treatment

SHAM

Device

sham treatment

Primary outcomes

  1. percentage of patient achieving fracture union

    Time frame: 12 months

Secondary outcomes

  1. pain

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Official study title

Phase 4 Study of Early Applied Pulsed Electromagnetic Field in the Treatment of Postoperative Delayed Union of Long-bone Fractures

Important dates

Study start
2007
Primary completion
2011
Study completion
2012
First posted
Apr 10, 2012
Registry last updated
Apr 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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