Actively Recruiting

Age: 18Years +
All Genders
ID04858217

Diagnostic Accuracy and Cost-effectiveness Analysis of Serum and Synovial Fluid Markers for the Diagnosis of Periprosthetic Hip and Knee Joint Infections

Led by Istituto Ortopedico Rizzoli · Updated on 2025-09-22

270

Participants Needed

1

Research Sites

41 weeks

Total Duration

On this page

Sponsors

I

Istituto Ortopedico Rizzoli

Lead Sponsor

I

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating diagnostic methods for periprosthetic joint infection (PJI), a serious complication following total joint replacement (TJR) surgeries, especially in hip and knee joints. The study aims to evaluate the accuracy and cost-effectiveness of combining different serum and synovial fluid markers to improve the diagnosis of PJI, helping to guide the choice of surgical and antimicrobial treatments. This observational study focuses on patients hospitalized for revision surgery due to suspected PJI or other causes around the replaced joint. The study involves analyzing various blood and synovial fluid markers such as white blood cell count, C-reactive protein, alpha-defensin, and others, measured within a week or two months depending on the marker. It compares combinations of these markers to identify those with the highest diagnostic accuracy and cost-effectiveness, based on established criteria by the Musculoskeletal Infection Society. This includes both preoperative and intraoperative assessments, aiming to accelerate diagnosis and optimize surgical strategies. Participants will undergo evaluations including blood tests, synovial fluid analysis, clinical and radiological examinations, and laboratory assessments of microbial resistance and biofilm formation. The primary outcomes are multiple inflammatory and infection markers measured within seven days or two months. The study monitors diagnostic effectiveness and microbial characteristics to improve PJI management. Participants are involved during their hospitalization for revision surgery, with no additional treatment interventions outside standard care. The study is expected to continue until March 2026.

CONDITIONS

Brief Title

Periprosthetic Joint Infections: Diagnostic Accuracy and Cost-effectiveness Analysis of Serum and Synovial Markers

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients requiring hip or knee replacement surgery for 'late' joint prosthesis infection present for at least 90 days from the date of arthroplasty
  • Patients requiring hip or knee replacement surgery for non-infectious causes present for at least 90 days, without prior re-operations on the same joint, and planned for one-step revision
  • Previous clinical data, laboratory, and radiological examinations must be available
Not Eligible

You will not qualify if you...

  • Patients with 'early' joint prosthesis infection with clinical symptoms lasting less than 90 days
  • Patients with joint prosthesis infection involving joints other than hip or knee
  • Patients with severe cognitive impairment or psychiatric disorders
  • Pregnant women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 2 months

Participants undergo serum and synovial fluid tests to evaluate markers for diagnosing periprosthetic joint infections.

1 to 2 visits depending on tests performed

Long-term Monitoring

Duration - Up to 2 months

Participants are observed for outcomes related to infection diagnosis and antimicrobial resistance after diagnostic evaluation.

Follow-up assessments may occur depending on initial findings

Trial Site Locations

Total: 1 location

1

IRCCS Istituto Ortopedico Rizzoli

Bologna, Italy, 40134

Actively Recruiting

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Research Team

G

Gianluca Giavaresi, MD

M

Milena Fini, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Trends in Periprosthetic Hip Infection and Associated Costs: A Population-Based Study Assessing the Impact of Hospital Factors Using National Data.

Robert L Brochin, Kevin Phan, Jashvant Poeran...

https://pubmed.ncbi.nlm.nih.gov/29573912

2018 International Consensus Meeting on Musculoskeletal Infection: Research Priorities from the General Assembly Questions.

Edward M Schwarz, Javad Parvizi, Thorsten Gehrke...

https://pubmed.ncbi.nlm.nih.gov/30977537

Health Care Needs and Support for Patients Undergoing Treatment for Prosthetic Joint Infection following Hip or Knee Arthroplasty: A Systematic Review.

Setor K Kunutsor, Andrew D Beswick, Tim J Peters...

https://pubmed.ncbi.nlm.nih.gov/28046049

Executive summary: diagnosis and management of prosthetic joint infection: clinical practice guidelines by the Infectious Diseases Society of America.

Douglas R Osmon, Elie F Berbari, Anthony R Berendt...

https://pubmed.ncbi.nlm.nih.gov/23230301

New definition for periprosthetic joint infection: from the Workgroup of the Musculoskeletal Infection Society.

Javad Parvizi, Benjamin Zmistowski, Elie F Berbari...

https://pubmed.ncbi.nlm.nih.gov/21938532