NGS for Spine Surgery Patients
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Aseptic (uninfected) Revision Spine Surgery Aseptic revision for indications including but not limited to hardware failure, adjacent segment pathology, radiculopathy, instability, cord compression. |
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)
|
| 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 |
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)
|
| 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. |
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)
|
Outcome Measures
Primary Outcome Measures
- Postoperative complications [1 year]
complications that patients experience after surgery will be noted from the patient chart after they have been evaluated by their surgeon
- Patient Satisfaction [1 year]
will be measured using the Short Form 12 Physical and Mental Score (SF-12)
- Patient pain [1 year]
will be measured using the Visual Analog Scale Neck and Arm Pain Score (VAS)
Eligibility Criteria
Criteria
Inclusion Criteria:
- All patients >18 years of age undergoing spinal surgery
Exclusion Criteria:
- All patients <18 years of age undergoing spinal surgery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rothman Orthopaedic Institute | Philadelphia | Pennsylvania | United States | 19107 |
Sponsors and Collaborators
- Rothman Institute Orthopaedics
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CKEP21d.121