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Found 3 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the safety and performance of Teknimed's arthroplasty products, including CEMFIX e and GENTAFIX e bone cements and the CEMSTOP e cement restrictor, which have been used for over 20 years. These products are designed to help fix joint prostheses to bones during joint replacement surgeries, which commonly address conditions like osteoarthritis, osteonecrosis, and trauma. The study focuses on collecting real-life long-term safety and effectiveness data through a retrospective and prospective observational design. The study involves patients undergoing cemented joint arthroplasty procedures using Teknimed's bone cements and cement restrictor. It is a global, multicenter, single-arm, non-controlled study where participants will be followed according to local medical care standards. Both patients who have already had surgery with these products since January 2016 and those scheduled for such procedures are included. Participants will be monitored for up to 15 years, with primary outcomes including survival rate of the device and rates of superficial or deep postoperative infections. Data collection includes clinical follow-up visits and routine medical care assessments. The study aims to confirm the long-term safety and performance of Teknimed arthroplasty products in real-world use.
Actively Recruiting
Researchers are investigating factors that predict resistance to pembrolizumab, an immune therapy, in patients with metastatic colorectal cancer characterized by microsatellite instability (MSI) or mismatch repair deficiency (dMMR). This research follows findings from the Keynote 177 trial, which showed pembrolizumab's superiority over chemotherapy but also noted that 20-30% of patients experienced primary resistance. The goal is to identify biomarkers that can help determine who will benefit most from immunotherapy and who may need alternative treatments. This study involves a national French cohort including both retrospective and prospective patients treated with pembrolizumab as first-line therapy for MSI/dMMR metastatic colorectal cancer. Patients treated since February 2021 under compassionate use and those starting treatment from February 2024 onward will be included. Recruitment will take place across over 150 French public and private centers, with an anticipated total enrollment of 600 patients over two years. Participants will be followed for three years to monitor their response to pembrolizumab and identify factors linked to resistance. Researchers will collect clinical data and tumor characteristics to analyze predictive biomarkers. The primary outcome is to find factors that predict resistance over a two-year period. The study emphasizes long-term follow-up to better understand treatment outcomes and improve patient selection for immunotherapy.
Actively Recruiting
It is admitted that: * Bioabsorbable interference screws are frequently used for graft attachment in knee cruciate ligament reconstruction, * Bioabsorbable pins are indicated for the realignment and fixation of epiphyseal fractures, osteotomies, arthrodesis and bone grafts of toes, * Non-absorbable suture is usually used for the repair and the reinforcement of ligaments or tendons structures during surgery procedures, * Anchor devices are usually used for the repair of rotator cuff tendons and biceps tenodesis. Furthermore, resorption properties of many available devices (screws, pins) that are marketed as bioabsorbable may be different and not always very well defined. This retro-prospective study is performed to confirm the safety and performance of TEKNIMED sports surgery products in their current clinical use. Studied products include - but are not restricted to - the following TEKNIMED products: * EUROSCREW® NG * ISOFIX® * SUTUR'LINK® * A'LINK'S® * BIORESORBABLE PINS And following associated TEKNIMED instrumentation: * ACL Instrumentation * A'LINK'S® Instrumentation * STAINLESS STEEL PINS