NGS for Non-unions

NCT03937310 | Unknown

• 1 other identifier: Krieg2019
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonunion of Fracture

Outcome Measures

Primary Outcomes (1)

• Treatment failure

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

  6 months post-op

Study Arms (2)

Surgical intervention for non-union

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

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

Acute fracture fixation

The control group will consist of cases undergoing acute fracture fixation

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

Interventions

Next-generation sequencing of swabs collected during surgery DIAGNOSTIC_TEST

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

Acute fracture fixation; Surgical intervention for non-union

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients will be chosen based on intervention planned. This is not an interventional study, just an observational study

You may qualify if:

• 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

You may not qualify if:

• Pathological fractures at index injury
• Patients on antibiotic therapy \<2 weeks prior to surgery
• 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

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Fractures, Ununited

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: May 3, 2019
• Study Start: January 3, 2019
• Primary Completion: January 3, 2022
• Study Completion: February 3, 2022
• Last Updated: May 3, 2019

Record last verified: 2019-05

Locations

US (1)