SHort Interval Full Two-stage Implant Exchange
ConditionProsthetic-joint Infection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier
About this trial
This study is a prospective bicentric feasibility study, which aims to evaluate the feasibility of a two-stage full implant exchange with early prosthesis reimplantation between 16 and 30 days after implants removal for hip or knee prosthetic joint infection.
This study concern 50 patients, prospectively included and compared to the last 50 patients with hip or knee PJI managed with classical two-stage implant exchange.
The duration of the study is 42 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient over 18 years old
Patient managed for a definite osteoarticular infection in a hip or knee prosthesis according to EBJIS definitions (2021) Clinical definition : fistula communicating with the prosthesis, prosthesis exposed / Or biological ≥ 2 samples positive for the same microorganism / And/ or 3000 leukocytes or > 80% of PNN on the synovial fluid / Or histological: visible microorganism, > or = 5 PNN on 5 HPN
Patient managed before 31/12/2021 for a definite osteoarticular infection in a hip or knee prosthesis according to EBJIS definitions (2021) Clinical definition : fistula communicating with the prosthesis, prosthesis exposed Or biological ≥ 2 samples positive for the same microorganism And/ or 3000 leukocytes or > 80% of PNN on the synovial fluid Or histological: visible microorganism, > or = 5 PNN on 5 HPN
Patient managed by 2 "long" stage surgery with reimplantation time > 6 weeks with an evolutionary follow-up of at least 15 months after the end of antibiotics
Disqualifiers
Indication for conservative treatment, 1-stage or 2 long stage surgery
Reimplantation by another surgical approach requiring complete skin closure of the initial scar
Other surgeries scheduled within 30 days of removal
Participation in another interventional treatment study and/or in an exclusion period due to participation in another protocol
Trial design
Design model
Parallel
Treatments tested in this trial
Early prosthesis reimplantation
Procedure/SurgeryEarly prosthesis reimplantation, within 16 to 30 days after implants removal
Retrospective analysis of medical records
Other interventionAnalysis of 50 records of operated patients managed with classical two-stage implant exchange
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Prospective groupExperimental treatment 1 intervention
Group B: Retrospective groupOther 1 intervention
Trial outcomes
Primary outcomes
1
Rate of eligible patients included and benefiting from the standardized protocol without major deviations
Number of eligible patients having been included in the study having benefited from the standardized protocol without major deviations / number of eligible patients according to surgeons or doctors during consultations and hospitalization in orthopedic or infectious disease departments
Time frame
At 3 months follow-upSecondary outcomes
1
Rate of eligible patients included
Number of eligible patients included in the study / number of eligible patients according to surgeons or doctors during consultations and hospitalization in orthopedic or infectious disease departments
Time frame
At 3 months follow-up2
Rate of clinical cure
Number of patients included without signs of infectious relapse to the same germ or persistence of the initial infection at M15 / number of patients included who benefited from the standardized protocol without major deviations., compared to clinical cure rate in retrospective group
Time frame
At 15 months follow-up3
Rate of re-infection with a different microorganism (superinfection) during follow-up and up to M15
Number of patients who presented a reinfection according to the EBJIS criteria with a germ different from the initial organism(s) during follow-up / number of patients included who benefited from the standardized protocol without major deviations, compared to reinfection rate in retrospective group
Time frame
At 15 months follow-up4
Length of stay
Cumulative length of stay in hospital (medicine or surgery wards) or in follow-up care compared to cumulative length of stay in retrospective group
Time frame
At 15 months follow-upSponsors and contacts
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Source ClinicalTrials.gov