Actively Recruiting

Age: 18Years +
All Genders
ID02801253

Prospective Cohort Study of Patients With Prosthetic Joint Infection Monitoring Treatment Outcomes and Reinfection

Led by Groupe Hospitalier Diaconesses Croix Saint-Simon · Updated on 2022-03-29

800

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying prosthetic joint infections (PJI), which are infections occurring in people with hip, knee, or shoulder joint prostheses. These infections are complex and require different treatments depending on the infection type, bone condition, the infecting organism, and the patient's overall health. Managing PJI often involves surgery combined with long-term antibiotic therapy, but in patients at high surgical risk, prolonged antibiotic use without surgery may be used. This large, long-term observational study aims to better understand PJI management and outcomes. The study includes patients treated for PJI through various surgical approaches such as debridement-synovectomy for acute infections, one-stage or two-stage exchange arthroplasty for chronic infections, or complete prosthesis removal combined with antibiotic therapy. It also includes patients receiving prolonged suppressive antibiotic therapy without surgery. The study follows participants for at least two years, collecting data for up to ten years, with enrollment over four years and up to six years of data collection. Participants are monitored regularly for reinfections, joint mechanical failure, and survival outcomes related to PJI. Assessments include joint function evaluations at one, two, four, and six years after prosthesis revision surgery, and tracking treatment outcomes for those on prolonged antibiotic therapy. The main outcome measured is the number of reinfections within two years, along with analysis of risk factors. This long-term follow-up allows researchers to evaluate the effectiveness and challenges of different PJI management strategies.

CONDITIONS

Brief Title

Cohort of Prosthetic Joint Infections

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient aged over 18 years old with hip, knee, or shoulder joint prosthesis who consented to participate
  • Prosthetic joint infection diagnosed by either two positive periprosthetic cultures with identical organisms, or a sinus tract communicating with the joint, or at least four of six minor criteria including elevated CRP, ESR, synovial fluid white blood cell count, PMN%, pus presence, positive histology, or a single positive culture
  • Alternatively, PJI with medical history suggesting infection, pain for more than 3 months unrelated to mechanical cause, and germ identification in fluid or tissue cultures or prosthesis sonication fluid culture over 50 CFU/ml
Not Eligible

You will not qualify if you...

  • Patients not meeting the eligibility criteria
  • Patients lawfully deprived of their liberty
  • Patients not covered by a social security insurance scheme

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Monitoring

Duration - At least 2 years, up to 6 years

Participants who undergo routine care for prosthetic joint infections are observed to monitor treatment outcomes including reinfection and joint function.

Assessments at 1, 2, 4, and 6 years after prosthesis revision; ongoing follow-up visits depending on treatment type

Trial Site Locations

Total: 1 location

1

Groupe Hospitalier Diaconesses Croix Saint Simon

Paris, Île-de-France Region, France, 75020

Actively Recruiting

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Research Team

Y

YOUNES KERROUMI, Doctorate

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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