Boujan Sur Libron

This research aims to assess the safety and performance of Teknimed arthroplasty products, including the CEMFIX and GENTAFIX bone cement families and the CEMSTOP cement restrictor, which have been used for more than 20 years in joint replacement surgeries. The study focuses on real-life long-term data to confirm previous findings on these products safety and effectiveness in patients undergoing joint replacement due to osteoarthritis, osteonecrosis, trauma, or revision surgeries. The study is a global, multicenter, observational trial that collects both retrospective and prospective data from patients receiving primary or revision joint replacements involving Teknimed bone cements and cement restrictors. Different groups include patients undergoing knee, hip, or shoulder surgeries with various cement types. Patients receive treatment as part of their standard medical care, without additional interventions mandated by the study. Participants will be monitored according to local medical practices, with data collected on outcomes such as implant survival, infection rates, pain levels, patient satisfaction, function restoration, complications, and adverse events. The primary outcomes cover up to 15 years, focusing on device lifetime and postoperative infections, while secondary outcomes evaluate patient-reported and clinical measures over five years. This long-term follow-up aims to provide comprehensive safety and performance information for these arthroplasty products.

Researchers are investigating factors that predict resistance to pembrolizumab, an immunotherapy drug used as the first treatment in patients with metastatic colorectal cancer that shows microsatellite instability or deficient mismatch repair. This study follows up on findings that about 20-30% of patients treated with pembrolizumab show primary resistance, highlighting a need to better identify which patients will benefit from this therapy and which may need other treatments. This research involves a national French cohort called CORESIM, combining both retrospective and prospective patient groups. Patients who started pembrolizumab treatment since February 2021 are included retrospectively, while new patients beginning pembrolizumab from February 2024 will be enrolled prospectively. Tumor samples and blood will be collected to analyze predictive biomarkers. The study expects to include about 600 patients over a 2-year enrollment period. Participants will be followed for 3 years to monitor outcomes and gather data on pembrolizumab resistance. Tumor archives and blood samples will be collected to support the research. The primary goal is to identify factors linked to treatment resistance. The study is observational, meaning it tracks patients receiving standard care without assigning treatments. This long-term follow-up helps researchers understand how different factors affect response to pembrolizumab in metastatic colorectal cancer.

Researchers are conducting a global, single-arm, non-controlled observational study to assess the long-term performance, safety, and usability of Teknimeds range of sports surgery products. These devices, including bioabsorbable interference screws, pins, non-absorbable sutures, and anchors, are commonly used in orthopedic surgeries such as knee ligament reconstructions, shoulder repairs, and foot surgeries. This study aims to collect real-world safety and efficacy data to better understand these products behavior over time. The study involves patients undergoing orthopedic surgeries using various Teknimed devices like EUROSCREW NG, ISOFIX, SUTURLINK, ALINKS, and bioresorbable pins. Patients include those having surgeries on knee anterior and posterior cruciate ligaments, ankle, shoulder, and foot. The study collects data both retrospectively from surgeries performed since January 2016 and prospectively from patients planned for surgery with these products. Treatments are delivered as part of standard orthopedic surgical procedures. Participants will be followed according to local medical care standards, with assessments including joint function evaluation for up to 4 years and adverse event monitoring for 5 years. Secondary measures include pain levels, pain medication use, patient satisfaction, quality of life, radiological outcomes, and device usability during surgery. Data collection occurs during routine follow-ups and includes retrospective and prospective clinical information, ensuring comprehensive long-term monitoring of these orthopedic devices.