SHort Interval Full Two-stage Implant Exchange

NCT05642013 | Recruiting

• 1 other identifier: RECHMPL22_0231
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Prosthetic-joint Infection

Keywords

prosthetic joint infection; knee; hip; two-stage exchange

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Rate of eligible patients included

  At 3 months follow-up

• Rate of clinical cure

  At 15 months follow-up

• Rate of re-infection with a different microorganism (superinfection) during follow-up and up to M15

  At 15 months follow-up

• Length of stay

  At 15 months follow-up

• Articular functionnality

  At 6 months follow-up

Study Arms (2)

Prospective group

EXPERIMENTAL

50 patients prospectively included with early prosthesis reimplantation

Procedure: Early prosthesis reimplantation

Retrospective group

OTHER

Last 50 patients with hip or knee prosthetic-joint infection managed with classical two-stage implant exchange

Other: Retrospective analysis of medical records

Interventions

Early prosthesis reimplantation PROCEDURE

Early prosthesis reimplantation, within 16 to 30 days after implants removal

Prospective group

Retrospective analysis of medical records OTHER

Analysis of 50 records of operated patients managed with classical two-stage implant exchange

Retrospective group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (2)

CHU de Montpellier - Hôpital Saint-Eloi

Montpellier, 34090, France

RECRUITING

CH de Sète - Hôpitaux du bassin de Thau

Sète, 34200, France

RECRUITING

Study Officials

• Nathalie PANSU, MD

  Infectious Diseases department, Montpellier university hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie PANSU, MD

CONTACT

+33467339510; n-pansu@chu-montpellier.fr

Vincent LE MOING, MD PhD

CONTACT

+33467339510; v-le_moing@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 8, 2022
• Study Start: January 23, 2023
• Primary Completion: April 23, 2026
• Study Completion (Estimated): July 23, 2027
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)