Status:
TERMINATED
Trial to Evaluate UltraSound in the Treatment of Tibial Fractures
Lead Sponsor:
Bioventus LLC
Collaborating Sponsors:
McMaster University
Clinical Advances Through Research and Information Translation
Conditions:
Tibial Fractures
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine the effect of low-intensity, pulsed ultrasound on tibial fractures treated with intramedullary nailing.
Detailed Description
A randomized, placebo controlled, clinical trial to evaluate the safety and efficacy of low-intensity, pulsed ultrasound, applied to tibial fractures treated with intramedullary nailing.
Eligibility Criteria
Inclusion
- Males and females age 18 years or older
- Have an open or closed tibial fracture amenable to intramedullary nail fixation
Exclusion
- Tibial fracture associated with a vascular injury requiring repair
- Pilon fractures
- Tibial fractures that extend into the joint and require reduction
- Pathologic fractures • Bilateral tibial fractures
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
501 Patients enrolled
Trial Details
Trial ID
NCT00667849
Start Date
September 1 2008
End Date
December 1 2012
Last Update
December 8 2015
Active Locations (16)
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1
San Francisco General/Dept of Orthopedic Surgery
San Francisco, California, United States, 94110
2
Florida Orthopedic Institute
Tampa, Florida, United States, 33606
3
OrthoIndy
Indianapolis, Indiana, United States, 46202
4
University of Kentucky
Lexington, Kentucky, United States, 50436