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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

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.

Age: 18Years +All GendersPhase Not Applicable
2 locations
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Actively Recruiting

Researchers are conducting an observational and prospective multicenter study to evaluate the long-term performance and safety over 10 years of ATF Implants and Lap Mdical devices used in total hip arthroplasty or hemiarthroplasty. The study aims to collect clinical evidence on the survival rate of these hip prostheses and assess their safety and performance during this period. It also seeks feedback on the surgical instruments used for implant placement. The study follows patients before and after their hip replacement surgery using implants made by ATF Implants and Lap Mdical. Surgeons evaluate patients based on standard orthopedic surgery criteria and record any complications or adverse effects observed. The main focus is on tracking the 10-year survival rate of the implants, while secondary goals include monitoring hip joint function at multiple points before surgery, and at 6 months, 2, 5, 7, and 10 years after surgery. Participants will be followed over a 10-year period with regular assessments by the surgical team. These evaluations include clinical examinations and monitoring for any complications related to the implants or surgical instruments. The study gathers detailed data on hip joint performance and safety, helping to understand how well the implants work and last over a decade. This long-term follow-up provides important information for future patients and healthcare providers.

All Genders
13 locations