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NGS for Non-unions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03937310
Recruitment Status : Unknown
Verified May 2019 by Rothman Institute Orthopaedics.
Recruitment status was:  Enrolling by invitation
First Posted : May 3, 2019
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Study Description
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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 Intervention/treatment
Nonunion of Fracture Diagnostic Test: Next-generation sequencing of swabs collected during surgery

Study Design
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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 3, 2019
Estimated Primary Completion Date : January 3, 2022
Estimated Study Completion Date : February 3, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Groups and Cohorts
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Group/Cohort Intervention/treatment
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
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


Outcome Measures
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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
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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 <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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937310


Locations
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United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics
More Information
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT03937310    
Other Study ID Numbers: Krieg2019
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fractures, Ununited
Fractures, Bone
Wounds and Injuries