Tibial Fractures | Pulsed Electromagnetic Field (PEMF) Stimulation for Tibia Fractures
Tibial Fractures research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Device:Pulsed electromagnetic field stimulation
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: August 2005
Completed Date: August 2009
Phase: Phase 2
Primary Outcome: Surgical revision rate in the 12 months after fracture
Secondary Outcome: Fracture union rate at 12, 26 and 52 weeks after fracture
Study sponsors, principal investigator, and references
Principal Investigator: Ian A Harris, MBBS
Lead Sponsor: Sydney South West Area Health Service
Collaborator: Biomet Australia Pty Ltd.