Mainvilliers

This research aims to collect clinical data on the safety and performance of a range of TEKNIMED bone substitute products, including CERAFORM, TRIHA, NANOGEL, and their private labels. These synthetic bone substitutes have been used for over 20 years and are designed to fill bone voids in various surgical or traumatic bone defects. The study is a global, single-arm, non-controlled, multicenter observational study that follows patients according to the local standard medical care at each site. Participants will receive bone substitutes during surgeries such as bone grafting, spinal fusion, and cage filling. These products are bioresorbable and gradually replaced by natural bone during healing. The study includes both retrospective and prospective data collection, with the retrospective group having undergone surgery since January 1, 2015, and the prospective group being considered for surgery using these bone substitutes. The aim is to assess real-life safety and performance in current clinical practice. During the study, participants will be monitored through standard medical care visits up to 24 months to evaluate successful bone repair. Researchers will assess outcomes including pain relief, bone reconstruction, patient well-being, and satisfaction. Data collection involves clinical follow-ups and observations without additional procedures beyond routine care. The study extends until September 2032, ensuring long-term safety and effectiveness data in real-world settings.

Researchers are evaluating the Omnipod 5 Automated Insulin Delivery System in people with type 1 diabetes aged 2 years and older. This study aims to observe real-world use of the device over 12 months, focusing on blood sugar control, quality of life, patient satisfaction, and rates of acute diabetes complications. The study is non-interventional and prospective, involving multiple centers in France. Participants use the Omnipod 5 System, a tubeless automated insulin pump designed to deliver insulin under the skin and used with compatible continuous glucose monitors such as the FreeStyle Libre 2 Plus sensor. The study follows patients for 12 months after they start using the system in automated mode. During this time, researchers collect data on how well blood sugar levels are controlled and how participants use the device. Throughout the study, participants complete quality-of-life questionnaires and treatment satisfaction surveys at the start, 6 months, and 12 months. Data on glucose levels, insulin delivery, and diabetes complications are collected continuously during the 12-month period. Safety, device usage patterns, and reasons for stopping the system are also monitored. Participants remain under their usual medical care while contributing data to this observational study.

This research aims to collect real-life clinical data on the safety and performance of TEKNIMEDs range of spine bone cements, including SPINEFIX, HIGH V, OPACITY, and F20, along with their mixing and injection systems. These bone cements have been used for over 10 years, and their safety and effectiveness have been supported by previous studies. The study focuses on vertebroplasty, kyphoplasty, and pedicle screw augmentation procedures, which are used to treat painful vertebral compression fractures and improve mechanical stability, especially in osteoporotic patients. The study observes patients treated with TEKNIMED spine bone cements during vertebroplasty and kyphoplasty procedures, where cement is injected into fractured vertebrae to relieve pain and stabilize the bone. It also includes pedicular screw augmentation, where cement is injected to strengthen screw fixation. The study is non-controlled, multicentric, and combines both retrospective and prospective data collection, following patients according to local standard medical care. Participants will be monitored over time with assessments focusing on pain relief, quality of life, patient satisfaction, vertebral stabilization, and pain medication use for up to 24 months. Safety is tracked through adverse event collection over 10 years. Data are gathered from clinical records without altering usual care. This approach will provide long-term insights into the real-world use of TEKNIMED spine bone cements in spine surgery.