Status:

RECRUITING

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

Lead Sponsor:

Istituto Ortopedico Rizzoli

Collaborating Sponsors:

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Conditions:

Prosthetic Joint Infection

Eligibility:

All Genders

18+ years

Brief Summary

Total joint replacement (TJR) is an increasing effective procedure in orthopedics. However, TJR failure due to aseptic or septic loosening remains an important problem, often due to predisposing facto...

Detailed Description

Total joint arthroplasties (TJA) are constantly increasing in older and multi-morbid patients; knee and hip joints are the most frequently treated due to high incidence of osteoarthritis in these join...

Eligibility Criteria

Inclusion

  • Patients requiring hip or knee replacement surgery: i) for 'late' joint prosthesis infection, present for at least 90 days from the date of the arthroplasty (first surgical phase); II) for non-infectious causes (mobilization, wear, instability, misalignment, adverse reactions to local tissues or other aseptic causes), also present for at least 90 days, and which have not had other re-operations on the same joint, and which will be a one-step review;
  • Previous clinical data and laboratory and radiological examinations available.

Exclusion

  • Patients affected by 'early' joint prosthesis infection, with clinical symptom latency of less than 90 days (in this specific subset of patients there is in fact still considerable heterogeneity and little consensus about the diagnostic levels of white blood cell count and percentage of neutrophils).
  • Patients suffering from joint prosthesis infection involving joints other than the hip or knee.
  • Severe cognitive impairment or psychiatric disorders;
  • Pregnant women.

Key Trial Info

Start Date :

February 1 2022

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

March 31 2026

Estimated Enrollment :

270 Patients enrolled

Trial Details

Trial ID

NCT04858217

Start Date

February 1 2022

End Date

March 31 2026

Last Update

September 22 2025

Active Locations (1)

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1

IRCCS Istituto Ortopedico Rizzoli

Bologna, Italy, 40134