NGS for Spine Surgery Patients
Next Generation Sequencing for the Detection of Clinical and Subclinical Infection in Patient Undergoing Spine Surgery
1 other identifier
observational
450
1 country
1
Brief Summary
During revision spinal surgery for aseptic indications, there remains a concern that the failure may have resulted from undetectable subclinical infection. In the common revision indications of hardware loosening and adjacent segment disease it is possible that bacterial colonization and low-grade infection precipitated the failure event. There is also significant controversy on the role infectious processes have in the development of degenerative disc disease (modic changes). In particular, this study will investigate whether discogenic colonization with Propionibacterium acnes (P. acnes) can be associated with modic changes. Whereas, in surgery for known spinal infection, epidural abscess and septic revisions, it is possible that standard culture techniques fail to detect polymicrobial flora or accurate speciation. This may lead to inappropriate antibiotic management that is not addressing the range of pathology present. There remains an incomplete understanding of the role that subclinical infection plays in aseptic spinal revision surgery and degenerative disc disease
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 18, 2021
CompletedFirst Submitted
Initial submission to the registry
August 13, 2021
CompletedFirst Posted
Study publicly available on registry
August 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedAugust 19, 2021
August 1, 2021
1 year
August 13, 2021
August 13, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Postoperative complications
complications that patients experience after surgery will be noted from the patient chart after they have been evaluated by their surgeon
1 year
Patient Satisfaction
will be measured using the Short Form 12 Physical and Mental Score (SF-12)
1 year
Patient pain
will be measured using the Visual Analog Scale Neck and Arm Pain Score (VAS)
1 year
Study Arms (3)
Aseptic (uninfected) Revision Spine Surgery
Aseptic revision for indications including but not limited to hardware failure, adjacent segment pathology, radiculopathy, instability, cord compression.
Spine Surgery for Degenerative Disease
Primary degenerative pathology surgery where a disc sample is extracted to enable spinal decompression or fusion. The potential primary surgeries include but are not limited to microdiscectomy, laminectomy, and lumbar and cervical fusion
Septic (infected) Revision Spine Surgery
Spine surgery for known infection specifically: epidural abscess or septic revision. Epidural abscess must be managed surgically for inclusion. Septic revision cases include any surgery to address infected hardware from a previous spinal surgery.
Interventions
Discarded tissue collected during surgery will be sent to the hospital microbiological lab for aerobic and anaerobic
Discarded tissue collected during surgery will be sent to an outside lab for testing using next generation sequencing (NGS)
Eligibility Criteria
Patients who are having spine surgery who are \>18 years old for degenerative disease, infection, and malignancy.
You may qualify if:
- All patients \>18 years of age undergoing spinal surgery
You may not qualify if:
- All patients \<18 years of age undergoing spinal surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107, United States
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2021
First Posted
August 19, 2021
Study Start
February 18, 2021
Primary Completion
February 28, 2022
Study Completion
February 28, 2022
Last Updated
August 19, 2021
Record last verified: 2021-08