Study Evaluating CERAMENT™|G in Open Diaphyseal Tibial Fractures
- Conditions
- Tibial Fracture
- Interventions
- Device: CERAMENT|GProcedure: SOC treatment
- 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
- Arm && Interventions
Group Intervention Description Test CERAMENT|G Tibial fracture fixation with IM Nail. Apply CERAMENT™\|G applied to bony void(s). Test SOC treatment Tibial fracture fixation with IM Nail. Apply CERAMENT™\|G applied to bony void(s). Control SOC treatment Tibial fracture fixation with IM nail.
- 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 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
University of Chicago
🇺🇸Chicago, Illinois, United States
University of Missouri Health
🇺🇸Columbia, Missouri, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
New York University, Bellevue Hospital
🇺🇸New York, New York, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
Essen University Hospital
🇩🇪Essen, Germany
Klinikum Bayreuth
🇩🇪Bayreuth, Germany
BG Hospital Ludwigshafen
🇩🇪Ludwigshafen, Germany
LMU Munich
🇩🇪Munich, Germany
Universitätsklinikum Regensburg
🇩🇪Regensburg, Germany
Universitätsmedizin Mainz
🇩🇪Mainz, Germany
Rechts der Isar Hospital
🇩🇪Munich, Germany
The Royal London Hospital
🇬🇧London, United Kingdom
University Hospital Coventry
🇬🇧Coventry, United Kingdom
Samodzielny Publiczny Wojewodzki Szpital
🇵🇱Szczecin, Poland
King's College Hospital
🇬🇧London, United Kingdom
Imperial College
🇬🇧London, United Kingdom
University Hospitals
🇬🇧Manchester, United Kingdom
Southampton General Hospital
🇬🇧Southampton, United Kingdom
Department of Orthopedics Greenville Health System
🇺🇸Greenville, South Carolina, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Denver Health Medical Center
🇺🇸Denver, Colorado, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of Texas Health Science Center
🇺🇸San Antonio, Texas, United States