Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Scientific title
A Double Blind Randomised Controlled Trial of Pulsed Electromagnetic Field (PEMF) Stimulation in Acute Tibial Shaft Fractures
Secondary ID [1] 0 0
05/023
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tibial Fractures 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Pulsed electromagnetic field stimulation

Treatment: Devices: Pulsed electromagnetic field stimulation
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Surgical revision rate in the 12 months after fracture
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Fracture union rate at 12, 26 and 52 weeks after fracture
Timepoint [1] 0 0
Secondary outcome [2] 0 0
General health score and lower extremity functional score at 12, 26 and 52 weeks after fracture
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
- Acute diaphyseal fracture of the tibia (AO classification 42)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Sydney
Recruitment hospital [2] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [3] 0 0
St George Hospital - Sydney
Recruitment hospital [4] 0 0
Nepean hospital - Sydney
Recruitment hospital [5] 0 0
Wollongong Hospital - Wollongong
Recruitment postcode(s) [1] 0 0
2145 - Sydney
Recruitment postcode(s) [2] 0 0
2170 - Sydney
Recruitment postcode(s) [3] 0 0
2217 - Sydney
Recruitment postcode(s) [4] 0 0
2570 - Sydney
Recruitment postcode(s) [5] 0 0
- Wollongong

Funding & Sponsors
Primary sponsor type
Other
Name
Sydney South West Area Health Service
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Biomet Australia Pty Ltd.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
St George Hospital, Australia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
South West Sydney Local Health District
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University of Wollongong
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00127725
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ian A Harris, MBBS
Address 0 0
Sydney South West Area Health Service
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ian A Harris, MBBS
Address 0 0
Country 0 0
Phone 0 0
+ 61 2 8777 5228
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00127725