Trial Outcomes & Findings for BBOT: Bacterial Burden in Ortho Trauma Procedures (NCT NCT03126448)
NCT ID: NCT03126448
Last Updated: 2020-04-28
Results Overview
The objective of this research is to see if highly sensitive bacterial assays are useful for determining whether fracture nonunions are infected
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
142 participants
Primary outcome timeframe
Study surgery to 6-month clinical follow-up
Results posted on
2020-04-28
Participant Flow
Participant milestones
| Measure |
Group 1: Closed Index Fractures
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.
Highly Sensitive Assays: Tissue will be collected at the time of surgery from patients in each arm of the study. In addition to tissue stored in RNAlater and sent to a research laboratory, cultures will also be sent to Quest Diagnostics for independent culture results.
|
Group 2: Hardware Removal From Healed Fractures
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.
Highly Sensitive Assays: Tissue will be collected at the time of surgery from patients in each arm of the study. In addition to tissue stored in RNAlater and sent to a research laboratory, cultures will also be sent to Quest Diagnostics for independent culture results.
|
Group 3: Index Treatment of Fracture Nonunions
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.
Highly Sensitive Assays: Tissue will be collected at the time of surgery from patients in each arm of the study. In addition to tissue stored in RNAlater and sent to a research laboratory, cultures will also be sent to Quest Diagnostics for independent culture results.
|
|---|---|---|---|
|
Overall Study
STARTED
|
56
|
49
|
37
|
|
Overall Study
COMPLETED
|
43
|
41
|
27
|
|
Overall Study
NOT COMPLETED
|
13
|
8
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BBOT: Bacterial Burden in Ortho Trauma Procedures
Baseline characteristics by cohort
| Measure |
Group 1: Closed Index Fractures
n=43 Participants
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.
Highly Sensitive Assays: Tissue will be collected at the time of surgery from patients in each arm of the study. In addition to tissue stored in RNAlater and sent to a research laboratory, cultures will also be sent to Quest Diagnostics for independent culture results.
|
Group 2: Hardware Removal From Healed Fractures
n=41 Participants
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.
Highly Sensitive Assays: Tissue will be collected at the time of surgery from patients in each arm of the study. In addition to tissue stored in RNAlater and sent to a research laboratory, cultures will also be sent to Quest Diagnostics for independent culture results.
|
Group 3: Index Treatment of Fracture Nonunions
n=27 Participants
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.
Highly Sensitive Assays: Tissue will be collected at the time of surgery from patients in each arm of the study. In addition to tissue stored in RNAlater and sent to a research laboratory, cultures will also be sent to Quest Diagnostics for independent culture results.
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43 years
STANDARD_DEVIATION 19 • n=99 Participants
|
46 years
STANDARD_DEVIATION 15 • n=107 Participants
|
47 years
STANDARD_DEVIATION 14 • n=206 Participants
|
45 years
STANDARD_DEVIATION 21 • n=7 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
50 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
61 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
29 participants
n=99 Participants
|
31 participants
n=107 Participants
|
21 participants
n=206 Participants
|
81 participants
n=7 Participants
|
|
ASA Physical Status Classification System
|
2.1 units on a scale
STANDARD_DEVIATION 0.7 • n=99 Participants
|
2.0 units on a scale
STANDARD_DEVIATION 0.8 • n=107 Participants
|
2.2 units on a scale
STANDARD_DEVIATION 0.5 • n=206 Participants
|
2.1 units on a scale
STANDARD_DEVIATION 0.8 • n=7 Participants
|
|
High Energy Injury
|
32 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
81 Participants
n=7 Participants
|
|
Compartment Syndrome
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Pre-operative Antibiotics Administered
|
43 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
109 Participants
n=7 Participants
|
|
Open Fracture
|
NA Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
NA Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Study surgery to 6-month clinical follow-upThe objective of this research is to see if highly sensitive bacterial assays are useful for determining whether fracture nonunions are infected
Outcome measures
| Measure |
Group 1: Closed Index Fractures
n=43 Participants
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.
Highly Sensitive Assays: Tissue will be collected at the time of surgery from patients in each arm of the study. In addition to tissue stored in RNAlater and sent to a research laboratory, cultures will also be sent to Quest Diagnostics for independent culture results.
|
Group 2: Hardware Removal From Healed Fractures
n=41 Participants
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.
Highly Sensitive Assays: Tissue will be collected at the time of surgery from patients in each arm of the study. In addition to tissue stored in RNAlater and sent to a research laboratory, cultures will also be sent to Quest Diagnostics for independent culture results.
|
Group 3: Index Treatment of Fracture Nonunions
n=27 Participants
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.
Highly Sensitive Assays: Tissue will be collected at the time of surgery from patients in each arm of the study. In addition to tissue stored in RNAlater and sent to a research laboratory, cultures will also be sent to Quest Diagnostics for independent culture results.
|
|---|---|---|---|
|
Number of Participants With Tissue Samples Identified With Bacterial DNA According to Highly Sensitive Bacterial Assays
|
10 Participants
|
24 Participants
|
20 Participants
|
Adverse Events
Group 1: Closed Index Fractures
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2: Hardware Removal From Healed Fractures
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3: Index Treatment of Fracture Nonunions
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place