NGS for Non-unions
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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
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Condition or disease | Intervention/treatment |
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Nonunion of Fracture | Diagnostic Test: Next-generation sequencing of swabs collected during surgery |
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 |
Group/Cohort | Intervention/treatment |
---|---|
Surgical intervention for non-union
The investigation group will consist of cases undergoing surgical intervention for non-union
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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
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Diagnostic Test: Next-generation sequencing of swabs collected during surgery
Traditional swabs for culturing as well as swabs for NGS testing will be collected |
- Treatment failure [ Time Frame: 6 months post-op ]Need for additional re-operation or intervention within follow-up period

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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 |
Investigational group:
Inclusion:
- 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:
- 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
Exclusion Criteria:
Exclusion:
- Pathological fractures at index injury
- Patients on antibiotic therapy <2 weeks prior to surgery
INCLUSION/ EXCLUSION CRITERIA FOR CONTROL GROUP:
Inclusion:
- 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
Exclusion:
- Pathological fractures at index injury
- Patients on antibiotic therapy <2 weeks prior to surgery

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
United States, Pennsylvania | |
Rothman Institute | |
Philadelphia, Pennsylvania, United States, 19107 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Fractures, Ununited Fractures, Bone Wounds and Injuries |