Pulsed Electromagnetic Field (PEMF) Stimulation for Tibia Fractures

Summary

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.

Conditions

• Tibial Fractures

Interventions

DEVICE

Pulsed electromagnetic field stimulation

Sponsors & Collaborators

• Biomet Australia Pty Ltd.

  collaborator INDUSTRY

• St George Hospital, Australia

  collaborator OTHER

• South West Sydney Local Health District

  collaborator OTHER

• University of Wollongong

  collaborator OTHER

• Sydney South West Area Health Service

  lead OTHER_GOV

Principal Investigators

• Ian A Harris, MBBS · Sydney South West Area Health Service

• Hamish C Rae, MBBS · Sydney South West Area Health Service

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2005-08-31

Completion

2009-08-31

Countries

• Australia

Study Locations