NGS for Non-unions

Rothman Institute Orthopaedics120 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Nonunion of Fracture

Interventions

Next-generation sequencing of swabs collected during surgeryDIAGNOSTIC_TEST

Traditional swabs for culturing as well as swabs for NGS testing will be collected

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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/ EXCLUSION CRITERIA FOR CONTROL GROUP: Inclusion: 1. Patients undergoing surgical intervention for nonunion following a traumatic closed long bone fractures (femur shaft, tibia, humerus) 2. \>18 years old and able to provide informed consent Exclusion: 1. Pathological fractures at index injury 2. Patients on antibiotic therapy \<2 weeks prior to surgery

Locations (1)

Rothman Institute

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Treatment failure

Need for additional re-operation or intervention within follow-up period

Time frame: 6 months post-op

Data from ClinicalTrials.gov

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