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
Qualifiers
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
Treatments tested in this trial
- Early prosthesis reimplantation
- Retrospective analysis of medical records
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov