NCT05013203

NGS for Spine Surgery Patients

Next Generation Sequencing for the Detection of Clinical and Subclinical Infection in Patient Undergoing Spine Surgery

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 450 (estimated)
• Sponsor: Rothman Institute Orthopaedics · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

Type	Name	Description
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)

Timeline

• Start date: 2021-02-18
• Primary completion: 2022-02-28
• Completion: 2022-02-28
• First posted: 2021-08-19
• Last updated: 2021-08-19

Locations

1 site across 1 country: United States