MedTrace Logo

NGS for Spine Surgery Patients

NCT05013203 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2021-08-19

No results posted yet for this study

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

Conditions

  • Spine Infection

Interventions

DIAGNOSTIC_TEST

Tissue culture

Discarded tissue collected during surgery will be sent to the hospital microbiological lab for aerobic and anaerobic

DIAGNOSTIC_TEST

Next Generation Sequencing

Discarded tissue collected during surgery will be sent to an outside lab for testing using next generation sequencing (NGS)

Sponsors & Collaborators

  • Rothman Institute Orthopaedics

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-18
Primary Completion
2022-02-28
Completion
2022-02-28

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05013203 on ClinicalTrials.gov