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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 |
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Information provided by: | Sydney South West Area Health Service |
ClinicalTrials.gov Identifier: | NCT00127725 |
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 |
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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 |
Estimated Enrollment: | 340 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | August 2009 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Principal Investigator: | Ian A Harris, MBBS | Sydney South West Area Health Service |
Principal Investigator: | Hamish C Rae, MBBS | Sydney South West Area Health Service |
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 |
tibia fracture PEMF electromagnetic |
non-union revision Diaphyseal fractures of the tibia |
Fractures, Bone Wounds and Injuries Disorders of Environmental Origin Leg Injuries Tibial Fractures |
Fractures, Bone Wounds and Injuries Disorders of Environmental Origin Leg Injuries Tibial Fractures |