Mainvilliers

Researchers are evaluating the safety and clinical performance of TEKNIMED bone substitutes, including CERAFORM, TRIHA+, NANOGEL, and their private labels, used to fill bone voids. These products have been on the market for over 20 years with prior evidence of safety and effectiveness. This study aims to confirm those findings by collecting real-world data from a global, multicenter, observational study that includes both retrospective and prospective patient information. The study involves patients who have undergone or will undergo surgeries requiring bone filling with one of the TEKNIMED bone substitutes as per their intended use. These substitutes serve as alternatives to bone grafts from the patient or donors and are designed to be bioresorbable, gradually replaced by natural bone during healing. The study covers various surgical uses such as bone defect repair, spine fusion, and cage filling procedures. Treatments are delivered according to local medical care standards without experimental interventions. Participants will be followed according to routine medical care with data collected over time to assess successful bone repair at 24 months. The study collects clinical data on safety and performance through regular follow-ups, without additional procedures beyond standard care. Both retrospective data from surgeries since January 2015 and prospective data from ongoing treatments are included, contributing to a comprehensive understanding of these bone substitutes in daily clinical practice.

Researchers are evaluating the Omnipod 5 Automated Insulin Delivery System in people with type 1 diabetes aged 2 years and older in France. This study aims to gather real-world data on blood sugar control, quality of life, patient satisfaction, and rates of acute diabetes complications over a 12-month period following the start of automated insulin delivery with the Omnipod 5 system. Participants will use the Omnipod 5 system, a tubeless insulin pump designed to deliver insulin automatically when paired with compatible Dexcom continuous glucose monitors (G6 or G7). The study follows patients who have been prescribed a commercial version of this system and have not used it before. The system is intended to help manage diabetes by maintaining blood sugar levels within a target range. During the 12 months, participants will be monitored in a non-interventional way to observe their glycemic control and device usage in everyday life. Researchers will assess changes in the percentage of time blood sugar stays within the target range of 70 to 180 mg/dL, quality of life, satisfaction, and safety. Data will be collected through questionnaires and regular follow-up, with participants needing to understand and respond to study information and surveys in French.

This research aims to evaluate how the Omnipod 5 Automated Insulin Delivery System affects blood sugar control, quality of life, satisfaction, patient experience, and rates of sudden diabetes complications in real-world conditions. The study focuses on individuals with type 1 diabetes, both adults and children aged 2 years and older, who have started using the Omnipod 5 System with a FreeStyle Libre 2 Plus sensor in France. Participants use the Omnipod 5 System, a tubeless insulin pump that delivers insulin automatically when paired with compatible continuous glucose monitors. This non-interventional study follows patients for 12 months after they begin using the device in automated mode to collect data on device use and glycemic control. During the 12 months, researchers will monitor participants' blood glucose levels, quality of life, device safety, and usage patterns. They will measure changes in the time blood sugar stays within a target range (70-180 mg/dL) from baseline to 12 months. Participants will complete questionnaires and stay in contact with study staff throughout the follow-up period to track outcomes and ensure safety.

Researchers are evaluating the safety and performance of TEKNIMED Spine range bone cements, including SPINEFIX, HIGH V+, OPACITY+, and F20, as well as their mixing and injection systems in spine surgery. These bone cements have been used for over 10 years, and their safety and effectiveness were previously supported by post-market surveillance and clinical studies. This study aims to confirm these results by collecting data in real-world clinical settings through a retrospective and prospective observational design involving multiple centers globally. The study involves procedures such as vertebroplasty, kyphoplasty, and pedicular screw augmentation, where a medical-grade bone cement mixture is injected to relieve pain and improve mechanical stability in fractured vertebrae or to strengthen pedicle screw fixation. The study includes patients treated with TEKNIMED bone cements either retrospectively or prospectively, with follow-up conducted according to local standard medical care. This single-arm, non-controlled study collects data from these routine treatments without altering patient care. Participants will be monitored for up to 24 months focusing on pain relief as the primary outcome. Data collection includes clinical assessments aligned with routine care, and the study observes safety and performance in typical medical practice. Patients are followed over time to assess outcomes like pain alleviation, mobility improvement, and any complications. The study duration varies depending on the timing of patient inclusion and treatment but encompasses both retrospective and ongoing prospective data gathering.