Early Application of Pulsed Electromagnetic Field in the... | NCT01574833

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

NCT01574833

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Status

Completed

Last Update Posted

Apr 10, 2012Estimated

Enrollment

92Actual

Phase

Phase 4

Conditions

Fracture
Delayed Union of Fracture

Interventions

pulsed electromagnetic field
sham

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Oct 2011Actual

Completion Date

Jan 2012Actual

First Submitted Date

Apr 7, 2012

First Submission Date that Met QC Criteria

Apr 9, 2012

First Posted Date

Apr 10, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2012

Last Update Posted Date

Apr 10, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jin XIONG, Professor, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolPrincipal Investigator

Lead Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

92Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PEMF	Active Comparator	arm that receive PEMF treatment	Device: pulsed electromagnetic field
Sham	Sham Comparator	arm that receive sham treatment	Device: sham

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pulsed electromagnetic field	Device	PEMF treatment	PEMF
sham

Measure	Description	Time Frame
percentage of patient achieving fracture union		12 months

Measure	Description	Time Frame
pain		12 months

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School		Nanjing	Jiangsu	210008	China