NCT05642013 SHort Interval Full Two-stage Implant Exchange
| NCT ID | NCT05642013 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Montpellier |
| Condition | Prosthetic-joint Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-01-23 |
| Primary Completion | 2026-04-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2023-01-23 with a primary completion date of 2026-04-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Nathalie PANSU, MD
PRINCIPAL INVESTIGATOR
Infectious Diseases department, Montpellier university hospital
Frequently Asked Questions
Who can join the NCT05642013 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Prosthetic-joint Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05642013 currently recruiting?
Yes, NCT05642013 is actively recruiting participants. Contact the research team at n-pansu@chu-montpellier.fr for enrollment information.
Where is the NCT05642013 trial being conducted?
This trial is being conducted at Montpellier, France, Sète, France.
Who is sponsoring the NCT05642013 clinical trial?
NCT05642013 is sponsored by University Hospital, Montpellier. The principal investigator is Nathalie PANSU, MD at Infectious Diseases department, Montpellier university hospital. The trial plans to enroll 100 participants.