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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

NGS for Non-unions

Clinicaltrials.gov identifier NCT03937310

Recruitment Status Enrolling by invitation

First Posted May 3, 2019

Last update posted May 3, 2019

Study Description

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.

  • Condition or Disease:Nonunion of Fracture
  • Intervention/Treatment: Diagnostic Test: Next-generation sequencing of swabs collected during surgery
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 120 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: What is the Role of Next-generation Sequencing in Non-union of Orthopaedic Cases
  • Actual Study Start Date: January 2019
  • Estimated Primary Completion Date: January 2022
  • Estimated Study Completion Date: February 2022
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: Acute fracture fixation
The control group will consist of cases undergoing acute fracture fixation
Diagnostic Test: Next-generation sequencing of swabs collected during surgery
Traditional swabs for culturing as well as swabs for NGS testing will be collected
: 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
Traditional swabs for culturing as well as swabs for NGS testing will be collected
Outcome Measures
  • Primary Outcome Measures: 1. Treatment failure [ Time Frame: 6 months post-op ]
    Need for additional re-operation or intervention within follow-up period
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Probability Sample
  • Study Population: patients will be chosen based on intervention planned. This is not an interventional study, just an observational study
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 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

Contacts and Locations
Contacts
Locations

United States, Pennsylvania
Rothman Institute
Philadelphia

Sponsors and Collaborators

Rothman Institute Orthopaedics

More Information
  • Responsible Party: Rothman Institute Orthopaedics
  • ClinicalTrials.gov Identifier: NCT03937310 History of Changes
  • Other Study ID Numbers: Krieg2019
  • First Posted: May 3, 2019 Key Record Dates
  • Last Update Posted: May 3, 2019
  • Last Verified: May 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Fractures, Ununited