What is the Role of Next-generation Sequencing in Non-union of Orthopaedic Cases

Rothman Institute Orthopaedics1 site in 1 country120 target enrollmentJanuary 3, 2019

ConditionsNonunion of Fracture

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Nonunion of Fracture
Sponsor: Rothman Institute Orthopaedics
Enrollment: 120
Locations: 1
Primary Endpoint: Treatment failure
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 3, 2019

End Date

February 3, 2022

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Rothman Institute Orthopaedics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•Presumed Septic and Aseptic nonunions
•\>18 years old and able to provide informed consent

Exclusion Criteria

•Pathological fractures at index injury
•Patients on antibiotic therapy \<2 weeks prior to surgery
•INCLUSION/ EXCLUSION CRITERIA FOR CONTROL GROUP:
•Patients undergoing surgical intervention for nonunion following a traumatic closed long bone fractures (femur shaft, tibia, humerus)
•\>18 years old and able to provide informed consent
•Pathological fractures at index injury
•Patients on antibiotic therapy \<2 weeks prior to surgery