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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

Tracking Information
First Submitted Date May 1, 2019
First Posted Date May 3, 2019
Last Update Posted Date May 3, 2019
Actual Study Start Date January 3, 2019
Estimated Primary Completion Date January 3, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 1, 2019)
Treatment failure [ Time Frame: 6 months post-op ]
Need for additional re-operation or intervention within follow-up period
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title NGS for Non-unions
Official Title What is the Role of Next-generation Sequencing in Non-union of Orthopaedic Cases
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population patients will be chosen based on intervention planned. This is not an interventional study, just an observational study
Condition 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
Study Groups/Cohorts
  • Surgical intervention for non-union
    The investigation group will consist of cases undergoing surgical intervention for non-union
    Intervention: Diagnostic Test: Next-generation sequencing of swabs collected during surgery
  • Acute fracture fixation
    The control group will consist of cases undergoing acute fracture fixation
    Intervention: Diagnostic Test: Next-generation sequencing of swabs collected during surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 1, 2019)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 3, 2022
Estimated Primary Completion Date January 3, 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03937310
Other Study ID Numbers Krieg2019
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Rothman Institute Orthopaedics
Original Responsible Party Same as current
Current Study Sponsor Rothman Institute Orthopaedics
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Rothman Institute Orthopaedics
Verification Date May 2019