NGS for Spine Surgery Patients

Spine Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05013203
• Other study ID #: CKEP21d.121
• Status: Enrolling by invitation
• Start date: February 18, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: August 2021
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 450
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients >18 years of age undergoing spinal surgery

Exclusion Criteria:

• All patients <18 years of age undergoing spinal surgery

Related Conditions & MeSH terms

• Infection
• Spine Infection

Intervention

Diagnostic Test:
• Tissue culture
Discarded tissue collected during surgery will be sent to the hospital microbiological lab for aerobic and anaerobic
• Next Generation Sequencing
Discarded tissue collected during surgery will be sent to an outside lab for testing using next generation sequencing (NGS)

Locations

Country	Name	City	State
United States	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Patient Satisfaction	will be measured using the Short Form 12 Physical and Mental Score (SF-12)	1 year
Primary	Patient pain	will be measured using the Visual Analog Scale Neck and Arm Pain Score (VAS)	1 year