Nonunion of Fracture
Conditions
Brief summary
The purpose of this study is to investigate the role of genetic testing to look for possible infection as a cause for failure of non-healing fractures. The study aims to compare the results of genetic testing known as NGS to standardized clinical laboratory tests for diagnosing infections to see if NGS may be a better diagnostic tool.
Interventions
DIAGNOSTIC_TESTNext-generation sequencing of swabs collected during surgery
Traditional swabs for culturing as well as swabs for NGS testing will be collected
Sponsors
Rothman Institute Orthopaedics
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Investigational group: Inclusion: 1. Patients undergoing open biopsy / surgical intervention for nonunion following a traumatic (open or closed) long bone fracture (femur shaft, tibia, humerus) which was initially treated operatively.Inclusion Criteria: 2. Nonunions will be defined as a failure to progress towards expected union within an anticipated timeframe, and this judgment will be made by the attending caring for each patient. No specific timeframe or arbitrary cut points will be defined to allow for the considerable variation in fracture healing and different anatomical sites. 3. Presumed Septic and Aseptic nonunions 4. \>18 years old and able to provide informed consent
Exclusion criteria
Exclusion: 1. Pathological fractures at index injury 2. Patients on antibiotic therapy \<2 weeks prior to surgery INCLUSION/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment failure | 6 months post-op | Need for additional re-operation or intervention within follow-up period |
Countries
United States
Outcome results
None listed