Prospective Cohort of Patients With Prosthetic Joint Infection
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Prosthetic Joint Infection
- Sponsor
- Groupe Hospitalier Diaconesses Croix Saint-Simon
- Enrollment
- 800
- Locations
- 1
- Primary Endpoint
- Number of patients with hip and knee prosthetic joint reinfection (relapse and new infection) and multi-variable analysis of reinfection risk factors
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
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.
Investigators
Dr Valerie ZELLER
infectious diseases specialist
Groupe Hospitalier Diaconesses Croix Saint-Simon
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
Exclusion Criteria
- •Patient who does not meet eligibility criteria.
- •Patient lawfully deprived of his liberty.
- •Patient not insured under social security scheme.
Outcomes
Primary Outcomes
Number of patients with hip and knee prosthetic joint reinfection (relapse and new infection) and multi-variable analysis of reinfection risk factors
Time Frame: 2 years
Secondary Outcomes
- 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)