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SHort Interval Full Two-stage Implant Exchange

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Montpellier
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: Prospective group: * 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 with an indication for 2-stage surgery: A Impossibility of conservative treatment : infection occurring more than 4 weeks after prosthesis implantation, fistula, documented resistant germ, loosened prosthesis / B Unsuitable 1-stage change: recurrence after 1-stage management, precarious bone capital, documented resistant microorganism, infection without prior microbiological documentation, fistula, surgeon's assessment in disfavor \- Effective contraception during the research period for fertile women of childbearing age Retrospective group : * 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 Exclusion Criteria: Prospective group : * 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 * Subject not affiliated with a social security plan or beneficiary of such a plan * Failure to obtain written informed consent * Patient with a legal protection measure (guardianship, curatorship) * Patient under justice safeguard * Pregnant or breastfeeding woman Retrospective group : \- Refusal to participate Study exit criteria * Bacteriological samples positive for fungi * Infection not retained after analysis of samples (no sufficient clinical or biological criteria according to EBJIS definition) * Withdrawal of consent
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What it tests

  • Early prosthesis reimplantation
  • Retrospective analysis of medical records
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Where

2 sites
CHU de Montpellier - Hôpital Saint-Eloi
Montpellier, France
CH de Sète - Hôpitaux du bassin de Thau
Sète, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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