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NGS for Spine Surgery Patients

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05013203
Enrollment
450
Registered
2021-08-19
Start date
2021-02-18
Completion date
2022-02-28
Last updated
2021-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spine Infection

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

Interventions

DIAGNOSTIC_TESTTissue culture

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

DIAGNOSTIC_TESTNext Generation Sequencing

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

Sponsors

Rothman Institute Orthopaedics
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* All patients \>18 years of age undergoing spinal surgery

Exclusion criteria

* All patients \<18 years of age undergoing spinal surgery

Design outcomes

Primary

MeasureTime frameDescription
Postoperative complications1 yearcomplications that patients experience after surgery will be noted from the patient chart after they have been evaluated by their surgeon
Patient Satisfaction1 yearwill be measured using the Short Form 12 Physical and Mental Score (SF-12)
Patient pain1 yearwill be measured using the Visual Analog Scale Neck and Arm Pain Score (VAS)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026