Pulsed Electromagnetic Field (PEMF) Stimulation for Tibia Fractures
Recruitment status was Recruiting
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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 |
- Surgical revision rate in the 12 months after fracture
- 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 |
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| 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 | |
| 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 | |
| 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 | |
| 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 Wounds and Injuries Leg Injuries |
ClinicalTrials.gov processed this record on May 22, 2013