NCT00127725

Brief Summary

Fractures of the tibial shaft (diaphysis) are some of the most common long bone fractures. They most frequently occur in males less than 40 years of age. Despite advancements in the surgical management of these fractures, the precarious blood supply and lack of soft-tissue cover of the shaft of the tibia make these fractures vulnerable to non-union and infection. These complications often require multiple procedures, extended time off of work, and can result in ongoing poor mobility. This is reflected in the surgical revision rate that the scientific literature has recorded as being between 20 and 30%. Pulsed electromagnetic field (PEMF) stimulation has been shown to be a safe and effective treatment for non-unions of the tibia. These are fractures in which the bone has failed to unite and the healing process has ceased. The PEMF is delivered via a device such as the EBI Bone Healing System®, which straps onto the limb overlying the fracture. It is lightweight and portable using a rechargeable battery for power. It is compatible with internal and external fixation and may also be worn over a plaster or fibreglass cast. It is usually kept in place for ten hours per day and used for a period of three months or until the fracture unites. In animal models, PEMF stimulation has been demonstrated to improve the time to fracture healing in acute fractures. There have been no demonstrated side effects of the therapy. The study hypothesis is that PEMF stimulation during the first twelve weeks after fracture, in addition to normal surgical care, will increase the union rate for these fractures and thereby significantly reduce the surgical revision rate within the first twelve months following fracture.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
340

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2005

Typical duration for phase_2

Geographic Reach
1 country

5 active sites

Status
unknown

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

August 1, 2005

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2005

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

November 15, 2005

Status Verified

August 1, 2005

First QC Date

August 5, 2005

Last Update Submit

November 14, 2005

Conditions

Tibial Fractures

Keywords

tibiafracturePEMFelectromagneticnon-unionrevisionDiaphyseal fractures of the tibia

Outcome Measures

Primary Outcomes (1)

  • Surgical revision rate in the 12 months after fracture

Secondary Outcomes (2)

  • Fracture union rate at 12, 26 and 52 weeks after fracture

  • General health score and lower extremity functional score at 12, 26 and 52 weeks after fracture

Interventions

Pulsed electromagnetic field stimulationDEVICE

Eligibility Criteria

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

You may qualify if:

  • Acute diaphyseal fracture of the tibia (AO classification 42)

You may not qualify if:

  • Pathological fracture secondary to tumours.
  • Pregnant patients.
  • Patients with permanent pacemakers or defibrillators.
  • If the device is unable to be applied by 14 days post fracture.
  • Patients who lack the cognitive ability to consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Westmead Hospital

Sydney, New South Wales, 2145, Australia

RECRUITING

Liverpool Hospital

Sydney, New South Wales, 2170, Australia

RECRUITING

St George Hospital

Sydney, New South Wales, 2217, Australia

RECRUITING

Nepean hospital

Sydney, New South Wales, 2570, Australia

RECRUITING

Wollongong Hospital

Wollongong, New South Wales, Australia

NOT YET RECRUITING

MeSH Terms

Conditions

Tibial FracturesFractures, Bone

Condition Hierarchy (Ancestors)

Wounds and InjuriesLeg Injuries

Study Officials

  • Ian A Harris, MBBS

    Sydney South West Area Health Service

    PRINCIPAL INVESTIGATOR

  • Hamish C Rae, MBBS

    Sydney South West Area Health Service

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ian A Harris, MBBS

CONTACT

+ 61 2 8777 5228ian.harris@swsahs.nsw.gov.au

Hamish C Rae, MBBS

CONTACT

+ 61 2 8777 5228hamish.rae@sswahs.nsw.gov.au

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 5, 2005

First Posted

August 8, 2005

Study Start

August 1, 2005

Study Completion

August 1, 2009

Last Updated

November 15, 2005

Record last verified: 2005-08

Locations

AU(5)