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COPINS: Cohort of Prosthetic Joint Infections

Sponsor
Groupe Hospitalier Diaconesses Croix Saint-Simon (Other)
Overall Status
Recruiting
CT.gov ID
NCT02801253
Collaborator
(none)
800
Enrollment
1
Location
167.7
Anticipated Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    800 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Cohort of Patients With Prosthetic Joint Infection
    Actual Study Start Date :
    Sep 11, 2015
    Anticipated Primary Completion Date :
    Sep 1, 2025
    Anticipated Study Completion Date :
    Sep 1, 2029

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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]

    2. Assessment of mechanical failure rate six years after prosthesis revision with one or two stage exchange arthroplasty [6 years]

    3. 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]

    4. Assessment of reinfection rate of shoulder PJI two years after prosthesis revision with one or two stage exchange arthroplasty. [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Groupe Hospitalier Diaconesses Croix Saint Simon Paris Ile De France France 75020

    Sponsors and Collaborators

    • Groupe Hospitalier Diaconesses Croix Saint-Simon

    Investigators

    • Principal Investigator: VALERIE ZELLER, Doctorate, Groupe Hospitalier Diaconesses Croix Saint-Simon

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Valerie ZELLER, infectious diseases specialist, Groupe Hospitalier Diaconesses Croix Saint-Simon
    ClinicalTrials.gov Identifier:
    NCT02801253
    Other Study ID Numbers:
    • ID RCB: 2014-A01100-47
    First Posted:
    Jun 15, 2016
    Last Update Posted:
    Mar 29, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Arthritis, Infectious

    Study Results

    No Results Posted as of Mar 29, 2022