Clinical trial NCT05642013: SHort Interval Full Two-stage Implant Exchange
Official title: SHort Interval Full Two-stage Implant Exchange
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prosthetic-joint Infection
Keywords: prosthetic joint infection
knee
hip
two-stage exchange
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: Prosthetic joint infection (PJI) is a rare but severe complication, with long and complex medico-surgical procedures ang high morbidity. Two-stage full implant exchange is commonly used for PJI, but the best time for prosthesis reimplantation remains unclear. Late reimplantation leads to prolonged immobilization, which can cause decubitus complications and altered joint functionnality.

The hypothesis is that reimplantation between 16 and 30 days after implants removal, earlier than suggested by some relatively old recommandations, associated with 12 weeks antibiotic therapy is a safe and efficient option, allowing shorter immobilization susceptible to improve joint functionnality.

The principal aim of this study is to evaluate the feasibility of a two-stage full implant exchange with early prosthesis reimplantation.

50 patients with knee or hip PJI eligible for two-stage implant exchange will be prospectively included in two french centers.

Surgical procedure will be standardized, with prothesis reimplantation within 16 to 30 days after implants removal, associated with 12 weeks adaptated antibiotherapy according to french recommendations.

Patients will be compared to the last 50 patients with hip or knee PJI managed with classical two-stage implant exchange in these centers until december 2021 (retrospective group).

Follow up consists of 7 clinical evaluations, from inclusion until month15 after prosthesis removal.

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

Primary outcomes:
measure: Rate of eligible patients included and benefiting from the standardized protocol without major deviations
timeFrame: At 3 months follow-up
Secondary outcomes:
measure: Rate of eligible patients included
timeFrame: At 3 months follow-up
measure: Rate of clinical cure
timeFrame: At 15 months follow-up
measure: Rate of re-infection with a different microorganism (superinfection) during follow-up and up to M15
timeFrame: At 15 months follow-up
measure: Length of stay
timeFrame: At 15 months follow-up
measure: Articular functionnality
timeFrame: At 6 months follow-up
measure: Articular functionnality
timeFrame: At 15 months follow-up
measure: Quality of life auto-evaluation score
timeFrame: At inclusion
measure: Quality of life auto-evaluation score
timeFrame: At 3 months follow-up
measure: Quality of life auto-evaluation score
timeFrame: At 15 months follow-up
measure: Antibiotics tolerance
timeFrame: From inclusion to 3 months follow-up
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Saint-Eloi
city: Sète
country: France
facility: CH de Sète - Hôpitaux du bassin de Thau
Study officials:
affiliation: Infectious Diseases department, Montpellier university hospital
name: Nathalie PANSU, MD
role: PRINCIPAL_INVESTIGATOR
References: