Serum Based Diagnosis of and Monitoring of Infection Recovery in Orthopedic Spine Implant Infections

Launched by UNIVERSITY OF COLORADO, DENVER · May 18, 2021

Keywords

ClinConnect Summary

This is a research study at the University of Colorado, Denver, testing a new way to diagnose and monitor infections in the spine caused by Staphylococcus aureus around spinal implants. The study will look at a lab-based antibody test called MENSA (a special fluid made from immune cells grown in the lab) to see if it can accurately identify spine infections and track how well treatment works over time. It’s an observational study, meaning researchers won’t give a new treatment but will collect blood, tissue from around the implants, and follow patients after surgery to see how MENSA relates to real infection status.

Who can join? Adults aged 18 to 85 who are undergoing revision spine surgery because an infection around spinal hardware is suspected. People who are immunosuppressed, have infections around non-spine implants, have a current diabetic foot infection, are pregnant, weigh under 110 pounds, or do not fit the age range are not eligible. Enrollment is by invitation, with about up to 200 participants planned. If you join, you’ll have extra blood draws and tissue collected during surgery, and you’ll come back for follow-up visits up to two years. The study aims to find out how well MENSA works compared with the usual diagnosis and how antibody levels change after treatment. There is no guarantee of personal benefit, and this study does not involve a new therapy. Completion is expected around May 2026.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • patients with known or suspected spinal infections associated with spinal orthopedic implant(s);
• • patients over 18 years of age and younger than 85;
• • patients undergoing spinal revision surgery.
• Exclusion Criteria:
• • Diagnosed as immuno-compromised or immuno-suppressed based on medication use;
• • On-going or previously diagnosed musculoskeletal infections associated non-spine hardware (e.g., prosthetic hip, prosthetic knee, prosthetic shoulder);
• • Current diabetic foot ulcer/infection;
• • Patients undergoing cancer treatment (including radiation and chemotherapies);
• • Pregnancy;
• • Absence of a spleen;
• • Over the age of 85 or under the age of 18.
• • Weigh less than 110 pounds, or for which it would otherwise be unsafe for them to undergo a blood draw.