SHort Interval Full Two-stage Implant Exchange (SHIFT)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Prosthetic-joint Infection
• Intervention / Treatment: Procedure: Early prosthesis reimplantation; Other: Retrospective analysis of medical records

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nathalie PANSU, MD; Phone Number: +33467339510; Email: n-pansu@chu-montpellier.fr
• Study Contact Backup: Name: Vincent LE MOING, MD PhD; Phone Number: +33467339510; Email: v-le_moing@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prospective group; 50 patients prospectively included with early prosthesis reimplantation	Procedure: Early prosthesis reimplantation; Early prosthesis reimplantation, within 16 to 30 days after implants removal
Other: Retrospective group; Last 50 patients with hip or knee prosthetic-joint infection managed with classical two-stage implant exchange	Other: Retrospective analysis of medical records; Analysis of 50 records of operated patients managed with classical two-stage implant exchange

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of eligible patients included and benefiting from the standardized protocol without major deviations	Number of eligible patients having been included in the study having benefited from the standardized protocol without major deviations / number of eligible patients according to surgeons or doctors during consultations and hospitalization in orthopedic or infectious disease departments	At 3 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of eligible patients included	Number of eligible patients included in the study / number of eligible patients according to surgeons or doctors during consultations and hospitalization in orthopedic or infectious disease departments	At 3 months follow-up
Rate of clinical cure	Number of patients included without signs of infectious relapse to the same germ or persistence of the initial infection at M15 / number of patients included who benefited from the standardized protocol without major deviations., compared to clinical cure rate in retrospective group	At 15 months follow-up
Rate of re-infection with a different microorganism (superinfection) during follow-up and up to M15	Number of patients who presented a reinfection according to the EBJIS criteria with a germ different from the initial organism(s) during follow-up / number of patients included who benefited from the standardized protocol without major deviations, compared to reinfection rate in retrospective group	At 15 months follow-up
Length of stay	Cumulative length of stay in hospital (medicine or surgery wards) or in follow-up care compared to cumulative length of stay in retrospective group	At 15 months follow-up
Articular functionnality	Knee Society Score or Harris Hip Score	At 6 months follow-up
Articular functionnality	Knee Society Score or Harris Hip Score	At 15 months follow-up
Quality of life auto-evaluation score	EQ-5D-5L score (auto-questionnary)	At inclusion
Quality of life auto-evaluation score	EQ-5D-5L score (auto-questionnary)	At 3 months follow-up
Quality of life auto-evaluation score	EQ-5D-5L score (auto-questionnary)	At 15 months follow-up
Antibiotics tolerance	Evaluation of antibiotics tolerance by clinical +/- biological evaluation	From inclusion to 3 months follow-up

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Nathalie PANSU, MD, Infectious Diseases department, Montpellier university hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 15, 2022
• Primary Completion (Anticipated): September 15, 2024
• Study Completion (Anticipated): December 15, 2025

Study Registration Dates

• First Submitted: November 29, 2022
• First Submitted That Met QC Criteria: November 29, 2022
• First Posted (Actual): December 8, 2022

Study Record Updates

• Last Update Posted (Actual): December 13, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: knee; hip; prosthetic joint infection; two-stage exchange
• Other Study ID Numbers: RECHMPL22_0231

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No