BBOT: Bacterial Burden in Ortho Trauma Procedures
Orthopaedic Trauma Infections
About this trial
This is an interventional diagnostic trial for Orthopaedic Trauma Infections focused on measuring Infection, Nonunion, Fracture healing
Eligibility Criteria
Inclusion Criteria:
- Closed fracture undergoing open reduction internal fixation, intramedullary nailing (IMN) where the fracture site is accessible, or staged treatment of a pilon or plateau that was initially treated by joint spanning external fixation.
- Plate and screw removal without clinical evidence of infection
- Index procedure for fracture nonunion
Exclusion Criteria:
- Index fracture surgery for an open fracture or intramedullary nailing with fracture site not accessible
- Hardware removal if fracture not already healed
- Index nonunion surgery being bone grafting of a 'critical' defect
- Pregnant females
Sites / Locations
- University of Maryland, Shock Trauma Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Other
Other
Other
Group 1: Closed Index Fractures
Group 2: Hardware Removal from Healed Fractures
Group 3: Index Treatment of Fracture Nonunions
Group 1 is clean, closed fractures undergoing index open reduction internal fixation (ORIF), intramedullary nailing (IMN) where the fracture site is accessible, or staged treatment of a pilon or plateau that was initially treated by joint spanning external fixation. Tissue obtained at the time of surgery will be sent to the research laboratory for culture and performance of the two highly sensitive assays.
Group 2 will include patients having a plate removed from a healed fracture without clinical evidence of infection and excluding history of open fracture. Tissue obtained at the time of surgery will be sent to the research laboratory for culture and performance of the two highly sensitive assays.
Group 3 will be patients that are undergoing an index procedure for fracture nonunion at a site where prior surgery has been undertaken for the fracture. Exclusions include bone grafting of 'critical' defects, active clinical infection, or < 3 months from index fracture fixation. Tissue obtained at the time of surgery will be sent to the research laboratory for culture and performance of the two highly sensitive assays.