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
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|
Large prospective cohort study in a French referral center for bone and joint infections.
- 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
- 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 Type :||Observational|
|Estimated Enrollment :||400 participants|
|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|
- 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 ]
- 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 ]
- Assessment of mechanical failure rate six years after prosthesis revision with one or two stage exchange arthroplasty [ Time Frame: 6 years ]
- 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 ]
- Assessment of reinfection rate of shoulder PJI two years after prosthesis revision with one or two stage exchange arthroplasty. [ Time Frame: 2 years ]
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
|Contact: YOUNES KERROUMI, Doctorate||(+33) 1 64 44 33 firstname.lastname@example.org|
|Groupe Hospitalier Diaconesses Croix Saint Simon||Recruiting|
|Paris, Ile De France, France, 75020|
|Contact: Younes KERROUMI, Doctorate (+33)1 44 64 33 84 email@example.com|
|Contact: Valérie ZELLER, Doctorate (+33)1 44 64 17 80 firstname.lastname@example.org|
|Principal Investigator:||VALERIE ZELLER, Doctorate||Groupe Hospitalier Diaconesses Croix Saint-Simon|