Cohort of Prosthetic Joint Infections
ConditionProsthetic Joint Infection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGroupe Hospitalier Diaconesses Croix Saint-Simon
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
According to musculoskeletal infection society definition: PJI is present when one of the major criteria exists or four out of six minor criteria.
Two positive periprosthetic cultures with phenotypically identical organisms, OR
A sinus tract communicating with the joint, OR
Elevated serum C-reactive protein (CRP) AND erythrocyte sedimentation rate (ESR)
Disqualifiers
Patient who does not meet eligibility criteria.
Patient lawfully deprived of his liberty.
Patient not insured under social security scheme.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
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
2 yearsSecondary outcomes
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 years2
Assessment of mechanical failure rate six years after prosthesis revision with one or two stage exchange arthroplasty
Time frame
6 years3
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 years4
Assessment of reinfection rate of shoulder PJI two years after prosthesis revision with one or two stage exchange arthroplasty.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov