Actively Recruiting
Feasibility Study of Early Prosthesis Reimplantation Within 16 to 30 Days After Implant Removal for Hip or Knee Joint Infection
Led by University Hospital, Montpellier · Updated on 2024-08-06
100
Participants Needed
2
Research Sites
65 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating a new approach to treat hip or knee prosthetic joint infections PJI by testing the feasibility of a two-stage complete implant exchange with early prosthesis reimplantation between 16 and 30 days after implant removal. This prospective bicentric study includes 50 patients and compares them to a retrospective group of 50 patients who underwent the classical two-stage implant exchange with longer intervals. The goal is to find a safer and more efficient timing for reimplantation that may reduce immobilization and improve joint function. Participants in the prospective group will undergo a standardized surgical procedure where the prosthesis is reimplanted within 16 to 30 days after removal, combined with 12 weeks of antibiotic therapy according to French guidelines. The retrospective group consists of patients treated with the traditional two-stage method involving a longer delay before reimplantation, typically over six weeks. Both groups will be monitored and compared to evaluate outcomes related to infection control and joint functionality. Throughout the study, participants will receive seven clinical evaluations from the time of inclusion until 15 months after prosthesis removal. Researchers will assess feasibility by measuring the rate of patients following the protocol without major deviations at 3 months. Additional outcomes include clinical cure rates, reinfection rates, length of hospital stay, joint function at 6 and 15 months, quality of life assessments, and antibiotic tolerance. The total study duration is 42 months, allowing comprehensive follow-up and analysis of early reimplantation benefits and risks.
CONDITIONS
Brief Title
SHort Interval Full Two-stage Implant Exchange
Research Team
N
Nathalie PANSU, MD
V
Vincent LE MOING, MD PhD
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