Status:
UNKNOWN
Pulsed Electromagnetic Field (PEMF) Stimulation for Tibia Fractures
Lead Sponsor:
Sydney South West Area Health Service
Collaborating Sponsors:
Biomet Australia Pty Ltd.
St George Hospital, Australia
Conditions:
Tibial Fractures
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 managemen...
Detailed Description
Study Objectives: This is a randomized controlled study whose objective is to determine whether PEMF stimulation as an adjunct therapy has a clinically significant effect on the morbidity associated ...
Eligibility Criteria
Inclusion
- Acute diaphyseal fracture of the tibia (AO classification 42)
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2009
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT00127725
Start Date
August 1 2005
End Date
August 1 2009
Last Update
November 15 2005
Active Locations (5)
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1
Westmead Hospital
Sydney, New South Wales, Australia, 2145
2
Liverpool Hospital
Sydney, New South Wales, Australia, 2170
3
St George Hospital
Sydney, New South Wales, Australia, 2217
4
Nepean hospital
Sydney, New South Wales, Australia, 2570