Status:
ENROLLING_BY_INVITATION
Serum Based Diagnosis of and Monitoring of Infection Recovery in Orthopedic Spine Implant Infections
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
University of Rochester
Conditions:
Staphylococcus Aureus Infection
Surgical Site Infection
Eligibility:
All Genders
18-85 years
Brief Summary
The goal of this study is to test a new way to diagnose and track treatment of spine infections caused by the bacteria Staphylococcus aureus.
Detailed Description
Ongoing Staphylococcus aureus (S. aureus) infections of the spine associated with orthopedic hardware implants elicit prominent immune responses against a repertoire of proteins characteristic of the ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 24 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04897971
Start Date
August 24 2021
End Date
May 1 2026
Last Update
April 3 2024
Active Locations (1)
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1
Univeristy of Colorado Denver
Aurora, Colorado, United States, 80045