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Pulsed Electromagnetic Field (PEMF) Stimulation for Tibia Fractures
This study is currently recruiting participants.
Verified by Sydney South West Area Health Service, August 2005
First Received: August 5, 2005   Last Updated: November 14, 2005   History of Changes
Sponsors and Collaborators: Sydney South West Area Health Service
Biomet Australia Pty Ltd
St George Hospital, Australia
Sydney West Area Health Service
University of Wollongong
Information provided by: Sydney South West Area Health Service
ClinicalTrials.gov Identifier: NCT00127725
  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 II

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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
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            
St George Hospital Recruiting
Sydney, New South Wales, Australia, 2217
Contact: Zoltan Szomor, MBBS     + 61 2 9350 1111        
Sub-Investigator: Zoltan Szomor            
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            
Westmead Hospital Recruiting
Sydney, New South Wales, Australia, 2145
Contact: John S Fox, MBBS     +61 2 9680 1315     jfox@orthopaedicassociates.com.au    
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            
Sponsors and Collaborators
Sydney South West Area Health Service
Biomet Australia Pty Ltd
St George Hospital, Australia
Sydney West Area Health Service
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

Study ID Numbers: 05/023
Study First Received: August 5, 2005
Last Updated: November 14, 2005
ClinicalTrials.gov Identifier: NCT00127725     History of Changes
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

Study placed in the following topic categories:
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries
Tibial Fractures

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries
Tibial Fractures

ClinicalTrials.gov processed this record on September 10, 2009