Cohort of Prosthetic Joint Infections

NCT ID: NCT02801253

Last Updated: 2022-03-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-09-11
• Study Completion Date: 2029-09-30

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.

Conditions

Prosthetic Joint Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Groupe Hospitalier Diaconesses Croix Saint-Simon

OTHER

Sponsor Role: lead

Responsible Party

Dr Valerie ZELLER

infectious diseases specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

VALERIE ZELLER, Doctorate

Role: PRINCIPAL_INVESTIGATOR

Groupe Hospitalier Diaconesses Croix Saint-Simon

Locations

Groupe Hospitalier Diaconesses Croix Saint Simon

Paris, Île-de-France Region, France

Site Status: RECRUITING

Countries

France

Central Contacts

YOUNES KERROUMI, Doctorate

Role: CONTACT

ykerroumi@hopital-dcss.org

(+33) 1 64 44 33 84

Facility Contacts

Younes KERROUMI, Doctorate

Role: primary

ykerroumi@hopital-dcss.org

(+33)1 44 64 33 84

Valérie ZELLER, Doctorate

Role: backup

vzeller@hopital-dcss.org

(+33)1 44 64 17 80

Other Identifiers

ID RCB: 2014-A01100-47

Identifier Type: -

Identifier Source: org_study_id