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Pulsed Electromagnetic Field (PEMF) Stimulation for Tibia Fractures

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2005 by Sydney South West Area Health Service.
Recruitment status was:  Recruiting
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 Identifier:
First received: August 5, 2005
Last updated: November 14, 2005
Last verified: August 2005

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 identifier: NCT00127725

Australia, New South Wales
Westmead Hospital
Sydney, New South Wales, Australia, 2145
Liverpool Hospital
Sydney, New South Wales, Australia, 2170
St George Hospital
Sydney, New South Wales, Australia, 2217
Nepean hospital
Sydney, New South Wales, Australia, 2570
Wollongong Hospital
Wollongong, New South Wales, Australia
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
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 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:
Diaphyseal fractures of the tibia

Additional relevant MeSH terms:
Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries processed this record on January 17, 2017