NGS for Spine Surgery Patients

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Spine Infection
• Intervention / Treatment: Diagnostic test: Tissue culture; Diagnostic test: Next Generation Sequencing

• Study Type: Observational
• Enrollment (Anticipated): 450

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Orthopaedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who are having spine surgery who are >18 years old for degenerative disease, infection, and malignancy.

Description

Inclusion Criteria:

• All patients >18 years of age undergoing spinal surgery

Exclusion Criteria:

• All patients <18 years of age undergoing spinal surgery

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	complications that patients experience after surgery will be noted from the patient chart after they have been evaluated by their surgeon	1 year
Patient Satisfaction	will be measured using the Short Form 12 Physical and Mental Score (SF-12)	1 year
Patient pain	will be measured using the Visual Analog Scale Neck and Arm Pain Score (VAS)	1 year

Collaborators and Investigators

• Sponsor: Rothman Institute Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2021
• Primary Completion (Anticipated): February 28, 2022
• Study Completion (Anticipated): February 28, 2022

Study Registration Dates

• First Submitted: August 13, 2021
• First Submitted That Met QC Criteria: August 13, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Actual): August 19, 2021
• Last Update Submitted That Met QC Criteria: August 13, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: CKEP21d.121

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No