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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00127725
Registration number
NCT00127725
Ethics application status
Date submitted
5/08/2005
Date registered
8/08/2005
Date last updated
15/11/2005
Titles & IDs
Public title
Pulsed Electromagnetic Field (PEMF) Stimulation for Tibia Fractures
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Scientific title
A Double Blind Randomised Controlled Trial of Pulsed Electromagnetic Field (PEMF) Stimulation in Acute Tibial Shaft Fractures
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Secondary ID [1]
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05/023
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Tibial Fractures
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Condition category
Condition code
Injuries and Accidents
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Fractures
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Surgical revision rate in the 12 months after fracture
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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Fracture union rate at 12, 26 and 52 weeks after fracture
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [2]
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General health score and lower extremity functional score at 12, 26 and 52 weeks after fracture
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Assessment method [2]
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Timepoint [2]
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Eligibility
Key inclusion criteria
* Acute diaphyseal fracture of the tibia (AO classification 42)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Westmead Hospital - Sydney
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Recruitment hospital [2]
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Liverpool Hospital - Sydney
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Recruitment hospital [3]
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St George Hospital - Sydney
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Recruitment hospital [4]
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Nepean hospital - Sydney
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Recruitment hospital [5]
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Wollongong Hospital - Wollongong
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Recruitment postcode(s) [1]
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2145 - Sydney
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Recruitment postcode(s) [2]
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2170 - Sydney
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Recruitment postcode(s) [3]
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2217 - Sydney
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Recruitment postcode(s) [4]
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2570 - Sydney
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Recruitment postcode(s) [5]
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- Wollongong
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Funding & Sponsors
Primary sponsor type
Government body
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Name
Sydney South West Area Health Service
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Biomet Australia Pty Ltd.
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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St George Hospital, Australia
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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South West Sydney Local Health District
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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University of Wollongong
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Address [4]
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Country [4]
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT00127725
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ian A Harris, MBBS
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Address
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Sydney South West Area Health Service
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Ian A Harris, MBBS
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Address
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Country
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Phone
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+ 61 2 8777 5228
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00127725
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