RecruitingNot ApplicableNCT05642013

SHort Interval Full Two-stage Implant Exchange

Sponsor

University Hospital, Montpellier

Enrollment

100 participants

Start Date

Jan 23, 2023

Study Type

INTERVENTIONAL

Conditions

Prosthetic joint infection

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

Min Age: 18 Years

Inclusion Criteria9

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 Criteria16

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