Sete

Researchers are evaluating the feasibility of a two-stage full implant exchange procedure with early prosthesis reimplantation for patients with hip or knee prosthetic joint infection (PJI). This condition involves serious infections that require complex surgical and medical treatment. The study aims to determine if reimplanting the prosthesis between 16 and 30 days after removal, combined with 12 weeks of tailored antibiotic therapy, can be a safe and effective option that reduces immobilization time and improves joint function compared to the traditional longer interval approach. The study involves 50 patients prospectively enrolled at two French centers who will receive standardized surgical treatment with prosthesis reimplantation occurring within 16 to 30 days after implant removal. This group will be compared to a retrospective group of 50 patients previously treated with the classical two-stage implant exchange method, which involves a longer reimplantation interval. The surgical and antibiotic protocols are carefully defined, and the study duration is planned for 42 months. Participants will undergo seven clinical evaluations from the time of inclusion until 15 months after prosthesis removal. Researchers will monitor treatment adherence, collect clinical and biological data, and assess the rate of eligible patients successfully completing the protocol without major deviations. The main outcome measured at 3 months follow-up is the proportion of patients benefiting from the standardized approach. Safety and effectiveness will be evaluated throughout the follow-up period.

This research aims to assess the long-term performance and safety of ATF Implants and Lapé Médical devices used in hip replacement surgeries, including total hip arthroplasty or hemiarthroplasty. It is a prospective, observational, multicenter study designed to collect clinical evidence over a 10-year period. The study focuses on patients receiving these specific hip prostheses to better understand their durability and safety outcomes. The study involves patients undergoing hip replacement surgery with implants manufactured by ATF Implants and Lapé Médical. Surgeons will select the most appropriate prosthesis based on individual patient factors and device instructions at the time of surgery. The evaluation includes monitoring both the hip prostheses and the surgical instruments used for their placement throughout the 10-year follow-up. Participants will be followed before and after surgery with regular evaluations by surgeon-investigators using established orthopedic criteria. Data on complications, adverse effects, and prosthesis performance will be recorded. The main outcome measured is the long-term survival rate of the implants over 10 years. Additional assessments will include safety, performance, and user feedback on the devices and instruments during the study period.