Pulsed Electromagnetic Field (PEMF) Stimulation for Tibia Fractures

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by Sydney South West Area Health Service.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Biomet Australia Pty Ltd.
St George Hospital, Australia
South West Sydney Local Health District
University of Wollongong
Information provided by:
Sydney South West Area Health Service
ClinicalTrials.gov Identifier:
NCT00127725
First received: August 5, 2005
Last updated: November 14, 2005
Last verified: August 2005
  Purpose

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.


Condition Intervention Phase
Tibial Fractures
Device: Pulsed electromagnetic field stimulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double Blind Randomised Controlled Trial of Pulsed Electromagnetic Field (PEMF) Stimulation in Acute Tibial Shaft Fractures

Resource links provided by NLM:


Further study details as provided by Sydney South West Area Health Service:

Primary Outcome Measures:
  • Surgical revision rate in the 12 months after fracture

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 340
Study Start Date: August 2005
Estimated Study Completion Date: August 2009
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127725

Contacts
Contact: Ian A Harris, MBBS + 61 2 8777 5228 ext 75228 ian.harris@swsahs.nsw.gov.au
Contact: Hamish C Rae, MBBS + 61 2 8777 5228 ext 75228 hamish.rae@sswahs.nsw.gov.au

Locations
Australia, New South Wales
Liverpool Hospital Recruiting
Sydney, New South Wales, Australia, 2170
Contact: Ian A Harris, MBBS    +61 2 8777 5228 ext 75228    ian.harris@swsahs.nsw.gov.au   
Contact: Hamish C Rae, MBBS    8777 5228 ext 875228    hamish.rae@sswahs.nsw.gov.au   
Principal Investigator: Ian A Harris, MBBS         
Nepean hospital Recruiting
Sydney, New South Wales, Australia, 2570
Contact: Simon P Coffey, MBBS    + 61 2 4732 3155    spcoffey@bigpond.net.au   
Sub-Investigator: Simon Coffey, MBBS         
St George Hospital Recruiting
Sydney, New South Wales, Australia, 2217
Contact: Zoltan Szomor, MBBS    + 61 2 9350 1111      
Sub-Investigator: Zoltan Szomor         
Westmead Hospital Recruiting
Sydney, New South Wales, Australia, 2145
Contact: John S Fox, MBBS    +61 2 9680 1315    jfox@orthopaedicassociates.com.au   
Wollongong Hospital Not yet recruiting
Wollongong, New South Wales, Australia
Contact: Stuart G Jansen, MBBS    +61 2 4229 9116    stuartjansen@bigpond.com   
Sub-Investigator: Stuart Jansen, MBBS         
Sponsors and Collaborators
Sydney South West Area Health Service
Biomet Australia Pty Ltd.
St George Hospital, Australia
South West Sydney Local Health District
University of Wollongong
Investigators
Principal Investigator: Ian A Harris, MBBS Sydney South West Area Health Service
Principal Investigator: Hamish C Rae, MBBS Sydney South West Area Health Service
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00127725     History of Changes
Other Study ID Numbers: 05/023
Study First Received: August 5, 2005
Last Updated: November 14, 2005
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Sydney South West Area Health Service:
tibia
fracture
PEMF
electromagnetic
non-union
revision
Diaphyseal fractures of the tibia

Additional relevant MeSH terms:
Fractures, Bone
Tibial Fractures
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on October 30, 2014