SHort Interval Full Two-stage Implant Exchange

Launched by UNIVERSITY HOSPITAL, MONTPELLIER · Nov 29, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new approach to treating infections in hip or knee joint replacements, specifically focusing on a method called two-stage full implant exchange. In this study, researchers want to see if it's safe and effective to replace the infected joint implant within a shorter time frame of 16 to 30 days after removing the old one. They will compare the results of 50 patients receiving this new treatment with 50 patients who had the traditional method, which typically takes longer.

To be eligible for this study, participants must be at least 18 years old and have a confirmed infection in their hip or knee implant that meets specific medical criteria. Additionally, they should not be suitable for other treatment options. If you join the study, you can expect close monitoring and follow-up care as part of the treatment process. The trial will last for about 42 months and is currently open for new participants. It's important for interested individuals to understand that they need to provide informed consent and may be excluded if they have certain medical conditions or are pregnant.

Gender

ALL

Eligibility criteria

• 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

Trial Officials