Cohort of Prosthetic Joint Infections

Recruiting

• Conditions: Prosthetic Joint Infection

• Registration Number: NCT02801253
• Lead Sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon

Brief Summary

Management of prosthetic joint infections (PJI) is a challenging task. These infections include different clinical and microbiological settings calling upon various treatment strategies according to infection type (acute or chronic), bone quality, the involved micro-organism and the patient's general condition and willing.

Treatment of PJI combines surgery and prolonged antibiotic therapy. In some patients with a high operative risk prolonged suppressive antibiotic therapy can be used.

Lack of large prospective studies motivated the conception of this cohort with a long term follow up, regardless to PJI management procedures.

Detailed Description

Large prospective cohort study in a French referral center for bone and joint infections.

Population

* all patients who consented to participate in the study with PJI treated with:

* debridement-synovectomy for acute infection

* with one-stage, two-stage exchange arthroplasty for chronic infection

* other procedures (complete removal of the prosthesis) and antibiotic therapy

* patients (non-operated or operated) receiving prolonged suppressive antibiotic therapy

Outcome:

* Follow-up at least 2 years

* Events monitored: reinfection including relapse and new infection, joint revision for mechanical failure, PJI related or non-related death Study duration: 10 years. Recruitment period: 4 years. Maximal duration of data collection: 6 years. Investigator center: monocenter study. Mean patient inclusion per year: 100 patients per year.

Study Timeline

• Study Start: 2015-09-11
• Study First Submitted: 2016-05-27
• Study First Submitted QC: 2016-06-10
• Study First Posted: 2016-06-15
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-03-29
• Primary Completion: 2025-09
• Study Completion: 2029-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• Patient aged over 18 years old with hip, knee and or shoulder joint prosthesis who consented to participate in the study with:
• According to musculoskeletal infection society definition: PJI is present when one of the major criteria exists or four out of six minor criteria.

Major Criteria:

• Two positive periprosthetic cultures with phenotypically identical organisms, OR
• A sinus tract communicating with the joint, OR

Minor Criteria:

• Elevated serum C-reactive protein (CRP) AND erythrocyte sedimentation rate (ESR)
• Elevated synovial fluid white blood cell (WBC)
• Elevated synovial fluid polymorphonuclear neutrophil percentage (PMN%)
• The presence of pus in the joint without known cause
• Positive histological analysis of periprosthetic tissue
• A single positive culture

Or a PJI which meets the following three criteria:

• Medical story suggesting prosthetic joint infection.

• The presence of pain either with or without swelling for more than 3 months unrelated to a mechanical cause.

• Germ identification in a single sample of fluid aspiration or tissue culture.

  • Or microbial growth in prosthesis sonication fluid culture greater than 50CFU/ml.

Exclusion Criteria

• Patient who does not meet eligibility criteria.
• Patient lawfully deprived of his liberty.
• Patient not insured under social security scheme.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with hip and knee prosthetic joint reinfection (relapse and new infection) and multi-variable analysis of reinfection risk factors	2 years

Secondary Outcome Measures

Name	Time	Method
Assessment of treatment failure rate in patients with hip and knee PJI 2 years after prolonged suppressive antibiotic therapy in non-operated patients.	2 years
Assessment of reinfection rate of shoulder PJI two years after prosthesis revision with one or two stage exchange arthroplasty.	2 years
Assessment of joint function at one, two, four and 6 years after prosthesis revision with one or two stage exchange arthroplasty.	1, 2, 4, 6 years
Assessment of mechanical failure rate six years after prosthesis revision with one or two stage exchange arthroplasty	6 years

Trial Locations

Locations (1)

Groupe Hospitalier Diaconesses Croix Saint Simon; 🇫🇷 Paris, Ile De France, France