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Search / Trial NCT04897971

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

Spine, Orthopedic Implant Infection

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.

Locations

Aurora, Colorado, United States

Patients applied

0 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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