UnknownNot Applicable

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

United States200 participantsStarted 2021-08-24

Plain-language 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.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The percentage of Staphylococcus aureus spine implant associated infections correctly identified by "medium enriched for newly synthesized antibodies" (MENSA)

Timeframe: Baseline

Change "Medium enriched for newly synthesized antibodies" (MENSA) titers in the post-operative period

Timeframe: 2 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years post-surgery

"Medium enriched for newly synthesized antibodies" (MENSA) titers in spine implant infections compared to S. aureus infections of other orthopedic site infections.

Timeframe: Baseline

Trial details

NCT IDNCT04897971

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-05

View on ClinicalTrials.gov More Staphylococcus Aureus Infection trials

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

The percentage of Staphylococcus aureus spine implant associated infections correctly identified by "medium enriched for newly synthesized antibodies" (MENSA)

Timeframe: Baseline

Change "Medium enriched for newly synthesized antibodies" (MENSA) titers in the post-operative period

Timeframe: 2 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years post-surgery

"Medium enriched for newly synthesized antibodies" (MENSA) titers in spine implant infections compared to S. aureus infections of other orthopedic site infections.

Timeframe: Baseline