NCT01574833

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 10, 2012

Completed
Last Updated

April 10, 2012

Status Verified

April 1, 2012

Enrollment Period

4.6 years

First QC Date

April 7, 2012

Last Update Submit

April 9, 2012

Conditions

FractureDelayed Union of Fracture

Outcome Measures

Primary Outcomes (1)

  • percentage of patient achieving fracture union

    12 months

Secondary Outcomes (1)

  • pain

    12 months

Study Arms (2)

PEMF

ACTIVE COMPARATOR

arm that receive PEMF treatment

Device: pulsed electromagnetic field

Sham

SHAM COMPARATOR

arm that receive sham treatment

Device: sham

Interventions

pulsed electromagnetic fieldDEVICE

PEMF treatment

PEMF
shamDEVICE

sham treatment

Sham

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The failure of healing after at least 16 weeks and not more than 9 months following surgical reduction and fixation of the fracture.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Nanjing, Jiangsu, 210008, China

Location

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 7, 2012

First Posted

April 10, 2012

Study Start

March 1, 2007

Primary Completion

October 1, 2011

Study Completion

January 1, 2012

Last Updated

April 10, 2012

Record last verified: 2012-04

Locations

CN(1)