NGS for Spine Surgery Patients

Rothman Institute Orthopaedics

Status: Unknown

Conditions: Spine Infection

Treatments: Diagnostic Test: Next Generation Sequencing; Diagnostic Test: Tissue culture

Study type: Observational

Funder types: Other

Identifiers

NCT05013203

CKEP21d.121

Details and patient eligibility

About

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

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients >18 years of age undergoing spinal surgery

Exclusion criteria

• All patients <18 years of age undergoing spinal surgery

Trial design

450 participants in 3 patient groups

Aseptic (uninfected) Revision Spine Surgery

Description:

Aseptic revision for indications including but not limited to hardware failure, adjacent segment pathology, radiculopathy, instability, cord compression.

Treatment:

Diagnostic Test: Tissue culture

Diagnostic Test: Next Generation Sequencing

Spine Surgery for Degenerative Disease

Description:

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

Treatment:

Diagnostic Test: Tissue culture

Diagnostic Test: Next Generation Sequencing

Septic (infected) Revision Spine Surgery

Description:

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.

Treatment:

Diagnostic Test: Tissue culture

Diagnostic Test: Next Generation Sequencing