NGS for Non-unions

Nonunion of Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03937310
• Other study ID #: Krieg2019
• Status: Enrolling by invitation
• Start date: January 3, 2019
• Est. completion date: February 3, 2022

Study information

• Verified date: May 2019
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: February 3, 2022
• Est. primary completion date: January 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Ununited
• Nonunion of Fracture

Intervention

Diagnostic Test:
• Next-generation sequencing of swabs collected during surgery
Traditional swabs for culturing as well as swabs for NGS testing will be collected

Locations

Country	Name	City	State
United States	Rothman Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment failure	Need for additional re-operation or intervention within follow-up period	6 months post-op