NGS for Non-unions

• Conditions: Nonunion of Fracture
• Interventions: Diagnostic Test: Next-generation sequencing of swabs collected during surgery

• Registration Number: NCT03937310
• Lead Sponsor: Rothman Institute Orthopaedics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-03
• Status Verified: 2019-05
• Study First Submitted: 2019-05-01
• Study First Submitted QC: 2019-05-01
• Last Update Submitted: 2019-05-01
• Study First Posted: 2019-05-03
• Last Update Posted: 2019-05-03
• Primary Completion: 2022-01-03
• Study Completion: 2022-02-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgical intervention for non-union	Next-generation sequencing of swabs collected during surgery	The investigation group will consist of cases undergoing surgical intervention for non-union
Acute fracture fixation	Next-generation sequencing of swabs collected during surgery	The control group will consist of cases undergoing acute fracture fixation

Primary Outcome Measures

Name	Time	Method
Treatment failure	6 months post-op	Need for additional re-operation or intervention within follow-up period

Trial Locations

Locations (1)

Rothman Institute; 🇺🇸 Philadelphia, Pennsylvania, United States