Trial to Evaluate UltraSound in the Treatment of Tibial Fractures
- Conditions
- Tibial Fractures
- Registration Number
- NCT00667849
- Lead Sponsor
- Bioventus LLC
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 501
- Males and females age 18 years or older
- Have an open or closed tibial fracture amenable to intramedullary nail fixation
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Time (Days) to Radiographic Healing of Tibial Fractures over 365 days Days from randomization to day of x-ray assessed healed or, if not healed, day of premature withdrawal/study termination or day 365 (end of study visit)/ Kaplan-Meier
Change From Baseline in the SF-36 Physical Component Summary (PCS) Score of the Short Form-36 (SF-36) Over 365 days Assessments at baseline and 6 post baseline time points/ mixed effects repeated measure single point estimate. Range= -100 worst, 0 best
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
San Francisco General/Dept of Orthopedic Surgery
🇺🇸San Francisco, California, United States
Florida Orthopedic Institute
🇺🇸Tampa, Florida, United States
OrthoIndy
🇺🇸Indianapolis, Indiana, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Eastern Maine Medical Center
🇺🇸Bangor, Maine, United States
University of Missouri
🇺🇸Columbia, Missouri, United States
Insall Scott Kelly Institute
🇺🇸New York, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Rothman Institute
🇺🇸Philadelphia, Pennsylvania, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Scroll for more (6 remaining)San Francisco General/Dept of Orthopedic Surgery🇺🇸San Francisco, California, United States