What is the role of Next Generation Sequencing (NGS) in nonunion of orthopaedic cases?
R
Roman Natoli, MD
Primary Investigator
Enrolling By Invitation
18-100 years
All
Phase
N/A
30 participants needed
1 Location
Brief description of study
The purpose of this study is to investigate the role of Next Generation Sequencing (NGS), a molecular method to detect bacterial DNA presence, in 1) diagnosis of infected nonunion compared to microbiological culture and 2) compare NGS signal with clinical outcome and fracture healing.
Detailed description of study
Per standard of care preoperatively, all patients must have blood drawn to check for any infection. Preoperative radiographs and possible CT scans of the nonunion site will also we obtained in keeping with routine local standard of care. The study team will collect information relevant to the history of orthopaedic procedures from medical records and use it for this study.
Three tissue cultures will be obtained for each case as per routine standard of care. Further, additional tissue and intraoperative swabs from identical sites as the cultures will be sent for NGS. The NGS samples will be sent to MircroGenDx laboratory for sequencing bacterial DNA. The tissue used for NGS would normally be discarded at the time of surgery.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: all
-
Age: Between 18 Years - 100 Years
-
Gender: All
Individuals at least 18 years of age undergoing open biopsy/surgical intervention for nonunion following a traumatic open or closed long bone fracture (femur, tibia, humerus) which was initially treated operatively.
Individuals who have been on antibiotic therapy within 2 weeks of surgery will not be eligible.
Updated on
01 Aug 2024.
Study ID: 1907158823
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