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

Phase 4

Completed

• Conditions: Fracture; Delayed Union of Fracture
• Interventions: Device: pulsed electromagnetic field; Device: sham

• Registration Number: NCT01574833
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2011-10
• Study Completion: 2012-01
• Status Verified: 2012-04
• Study First Submitted: 2012-04-07
• Study First Submitted QC: 2012-04-09
• Last Update Submitted: 2012-04-09
• Study First Posted: 2012-04-10
• Last Update Posted: 2012-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEMF	pulsed electromagnetic field	arm that receive PEMF treatment
Sham	sham	arm that receive sham treatment

Primary Outcome Measures

Name	Time	Method
percentage of patient achieving fracture union	12 months

Secondary Outcome Measures

Name	Time	Method
pain	12 months

Trial Locations

Locations (1)

Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China