Serum Based Diagnosis of and Monitoring of Infection Recovery in Orthopedic Spine Implant Infections
Launched by UNIVERSITY OF COLORADO, DENVER · May 18, 2021
Trial Information
Current as of July 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
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 invading pathogen. Antibodies specific for these antigens can be measured in the serum or in a novel sample created by culturing circulating Antibody Secreting Cells (ASC) in vitro where they create an analytic fluid called here "medium enriched for newly synthesized antibodies" (MENSA). The hypothesis of this study addresses three essential attributes of this analytic approach that can yield b...
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.
About University Of Colorado, Denver
The University of Colorado, Denver, is a leading academic institution dedicated to advancing medical research and improving healthcare outcomes. With a strong emphasis on innovation and collaboration, the university conducts a diverse range of clinical trials aimed at addressing critical health challenges. Its research initiatives are supported by a multidisciplinary team of experts, state-of-the-art facilities, and a commitment to ethical standards and patient safety. By fostering partnerships with local and global communities, the University of Colorado, Denver, strives to translate scientific discoveries into meaningful advancements in clinical practice and public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Aurora, Colorado, United States
Patients applied
Trial Officials
Cheryl L Ackert-Bicknell, PhD
Principal Investigator
University of Colorado, Denver
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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