Study Evaluating CERAMENT™|G in Open Diaphyseal Tibial Fractures
- Conditions
- Tibial Fracture
- Registration Number
- NCT02820363
- Lead Sponsor
- BONESUPPORT AB
- Brief Summary
The purpose of this study is to demonstrate the safety and effectiveness of CERAMENT™\|G used in conjunction with standard-of-care treatment compared to standard-of-care treatment alone in the care of subjects with open fractures of the tibial diaphysis.
- Detailed Description
CERAMENT™\|G is a resorbable, gentamicin containing ceramic bone graft indicated to fill bony voids or gaps which are not intrinsic to the stability of the bony structure and where there is risk of bacterial contamination.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 201
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Composite of absence of deep infection at fracture site, absence of secondary procedures intended to promote fracture union, and improvement in the SF-36v2 PCS. 12 months Absence of secondary procedures, absence of infection.
Serious device related adverse events 12 months for the test (CERAMENT™\|G) arm
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (31)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of California
🇺🇸Irvine, California, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Cedars Sinai Medical Orthopedic
🇺🇸Los Angeles, California, United States
Harbor-UCLA Medical Center
🇺🇸Los Angeles, California, United States
Denver Health Medical Center
🇺🇸Denver, Colorado, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
University of Missouri Health
🇺🇸Columbia, Missouri, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Scroll for more (21 remaining)University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States