NGS for Spine Surgery Patients

• Conditions: Spine Infection

• Registration Number: NCT05013203
• Lead Sponsor: Rothman Institute Orthopaedics

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-18
• Status Verified: 2021-08
• Study First Submitted: 2021-08-13
• Study First Submitted QC: 2021-08-13
• Last Update Submitted: 2021-08-13
• Study First Posted: 2021-08-19
• Last Update Posted: 2021-08-19
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• All patients >18 years of age undergoing spinal surgery

Exclusion Criteria

• All patients <18 years of age undergoing spinal surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Rothman Orthopaedic Institute; 🇺🇸 Philadelphia, Pennsylvania, United States