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Found 3 Actively Recruiting clinical trials
RECRUITING
It is admitted that: * Surgeons are often concerned by bone void filling and they can choose between synthetic bone substitutes or bone grafts of animal or human origin. * Due to their chemical composition similar to bone tissue, synthetic bone substitutes are an interesting alternative to autografts and allografts which present some inconvenient (quantity to sample, infection of sampling site…). * Bone substitutes are bioresorbable and replaced by bone during the healing process (bone remodelling). * Nowadays, bone substitutes represent a common and efficient procedure to treat surgical or traumatic osseous defects. They are indicated and used in various pathologies and types of surgery, but they always have the same intended use: to fill a bone void. * Bone substitutes are also used in spine surgeries for cage filling and/or posterolateral fusion. TEKNIMED has developed several bone substitutes currently used in various types of surgery. Due to their increasing use, there is a need of real-life safety and efficacy data on these products. This retro-prospective study is performed to assess the safety and performance of TEKNIMED bone substitutes in their current clinical use.
RECRUITING
Twelve-month, real-world, non-interventional, prospective follow-up of adult and pediatric patients aged more than 2 years old, prescribed one of the Dexcom (Dexcom G6 or G7) configurations commercially available of the Omnipod 5 Automated Insulin Delivery System in France. OPTIMAL-A study (Omnipod 5 - A French Prospective Multicentric Study in Real World), aims to provide the requisite real-world data on the glycemic control, quality of life, safety, and device usage profiles of users of the Omnipod 5 System during the 12 months after starting using Omnipod 5 in automated mode.
RECRUITING
It is admitted that: * Cementoplasty procedures such as vertebroplasty and kyphoplasty are recommended in the treatment of painful vertebral compression fractures, due to their efficiency and safety * These mini-invasive procedures, where bone cement is injected into a partially collapsed vertebral body, are used to reduce pain and to provide mechanical stability * In most patients, a rapid pain relief and an increase in mobility and quality of life are obtained * Serious complications from bone cements leaks and adjacent vertebral fractures can be observed but remain rather rare * The use of spinal cement in pedicle screw augmentation procedures can be relevant to increase the strength of the screw fixation in the bone, particularly in osteoporotic patients. TEKNIMED has developed several bone cements currently used in vertebroplasty and kyphoplasty procedures in the treatment of vertebral weakness. Among those, one cement is also used in pedicle screw augmentation procedures. With the increasing use of these procedures, there is a need of real-life safety and efficacy data on the bone cements. This retro-prospective study is performed to confirm the safety and performance of TEKNIMED spine bone cements in their current clinical use.