NCT05642013

SHort Interval Full Two-stage Implant Exchange

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prosthetic-joint Infection

Interventions

Type	Name	Description
PROCEDURE	Early prosthesis reimplantation	Early prosthesis reimplantation, within 16 to 30 days after implants removal
OTHER	Retrospective analysis of medical records	Analysis of 50 records of operated patients managed with classical two-stage implant exchange

Timeline

• Start date: 2023-01-23
• Primary completion: 2026-04-23
• Completion: 2027-07-23
• First posted: 2022-12-08
• Last updated: 2024-08-06

Locations

2 sites across 1 country: France