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Cohort of Prosthetic Joint Infections (COPINS)

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ClinicalTrials.gov Identifier: NCT02801253
Recruitment Status : Recruiting
First Posted : June 15, 2016
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Dr Valerie ZELLER, 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.


Condition or disease
Prosthetic Joint Infection

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.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Cohort of Patients With Prosthetic Joint Infection
Actual Study Start Date : September 11, 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine





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 [ Time Frame: 4 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. [ Time Frame: 1, 2, 4, 6 years ]
  2. Assessment of mechanical failure rate six years after prosthesis revision with one or two stage exchange arthroplasty [ Time Frame: 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. [ Time Frame: 2 years ]
  4. Assessment of reinfection rate of shoulder PJI two years after prosthesis revision with one or two stage exchange arthroplasty. [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients managed in the investigators referral center of bone and joint infection, who meet protocol selection criteria will be included in the study. The investigators expect to recruit 400 patients.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02801253


Contacts
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Contact: YOUNES KERROUMI, Doctorate (+33) 1 64 44 33 84 ykerroumi@hopital-dcss.org

Locations
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France
Groupe Hospitalier Diaconesses Croix Saint Simon Recruiting
Paris, Ile De France, France, 75020
Contact: Younes KERROUMI, Doctorate    (+33)1 44 64 33 84    ykerroumi@hopital-dcss.org   
Contact: Valérie ZELLER, Doctorate    (+33)1 44 64 17 80    vzeller@hopital-dcss.org   
Sponsors and Collaborators
Groupe Hospitalier Diaconesses Croix Saint-Simon
Investigators
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Principal Investigator: VALERIE ZELLER, Doctorate Groupe Hospitalier Diaconesses Croix Saint-Simon

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Responsible Party: Dr Valerie ZELLER, infectious diseases specialist, Groupe Hospitalier Diaconesses Croix Saint-Simon
ClinicalTrials.gov Identifier: NCT02801253     History of Changes
Other Study ID Numbers: ID RCB: 2014-A01100-47
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Arthritis, Infectious
Arthritis
Joint Diseases
Musculoskeletal Diseases