NGS for Non-unions

Rothman Institute Orthopaedics

Status: Unknown

Conditions: Nonunion of Fracture

Treatments: Diagnostic Test: Next-generation sequencing of swabs collected during surgery

Study type: Observational

Funder types: Other

Identifiers

NCT03937310

Krieg2019

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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/ 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

Trial design

120 participants in 2 patient groups

Surgical intervention for non-union

Description:

The investigation group will consist of cases undergoing surgical intervention for non-union

Treatment:

Diagnostic Test: Next-generation sequencing of swabs collected during surgery

Acute fracture fixation

Description:

The control group will consist of cases undergoing acute fracture fixation

Treatment:

Diagnostic Test: Next-generation sequencing of swabs collected during surgery