[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"NEOS Surgery\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":66},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100621098","adjustable-carbon-fiber-sternal-plates-for-sternotomy-closure-100621098",false,"NCT07366203","Adjustable Carbon Fiber Sternal Plates for Sternotomy Closure","Clinical Investigation to Evaluate the Use of Adjustable Carbon Fiber Sternal Plates for Sternotomy Closure","FIX IT ALL","Inclusion Criteria:\n\n* Patient ≥ 18 years old.\n* Patient who must undergo surgery in which a median or an upper partial sternotomy is indicated.\n* Patients capable of giving their voluntary informed consent to participate in the clinical investigation and from whom written consent has been obtained.\n* Patient able and willing to meet the protocol requirements and to follow postoperative care instructions\n\nExclusion Criteria:\n\n* Patient with sternal anomalies, such as bone tumours located in the sternum.\n* Patient with limited sternum bone blood supply.\n* Patient with suspected or known allergies or intolerances to the implants materials: PEEK, carbon fibre, titanium, stainless steel.\n* Patient with severe osteoporosis or other degenerative bone diseases that affect the sternum.\n* Pregnant or breastfeeding patient or patient planning to become pregnant during the first 6 months after surgery.\n* Patient who is currently using opioid analgesics (e.g., morphine, oxycodone, hydrocodone, fentanyl, tramadol) for the management of chronic or acute pain.\n* Patient with diagnosis of dementia with a mental status score (MMSE) \\\u003C 20.\n* Patient with life expectancy lower than 6 months.\n* Patient with any other medical process that may compromise or limit the adequate functionality of the implants.\n* Patient involved in other interventionist clinical trial or that have been involved in other interventionist clinical trial during the previous 4 weeks.\n* Patient with signs of latent or active infection or inflammation on the surgical site.\n* Patient with insufficient quantity or quality of sternum bone, or other severe structural bone damage.\n* Patient for whom the closure technique cannot ensure sufficient sternal fixation.\n* Parasternal sternotomy.\n* Patient with intraoperative conditions that may compromise or limit the adequate functionality of the implants or that may prevent the surgeon to use the sternal closure system or that cannot be closed following the product instructions for use","ALL","18 Years",{"count":20,"type":21},190,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to learn if a new medical device (SC03 plates) to close the sternum after a sternotomy in patients that have been operated of a cardiac surgery, is safe and effective. The main question it aims to answer is:\n\nDo patients that have the sternum closed with the SC03 plates present a stable sternum one month after surgery?\n\nResearchers will compare the SC03 plates with stainless steel wires (current standard of care to close the sternum).\n\nParticipants will:\n\n* be implanted with the SC03 or stainless steel wires.\n* visit the clinic one month and six months after surgery\n* Keep a diary of their symptoms and analgesia use",[27],"Sternotomy Closure,Open Heart Surgery","NOT_YET_RECRUITING","2026-01-16",{"date":31,"type":32},"2026-01-26","ACTUAL",{"date":34,"type":21},"2026-02",{"date":36,"type":21},"2027-12",{"name":38,"class":39},"NEOS Surgery","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100517913","safety-and-performance-of-disc-care-to-prevent-lumbar-disc-herniation-recurrence-100517913","NCT06023719","Safety And Performance Of Disc Care To Prevent Lumbar Disc Herniation Recurrence","Multicentric Clinical Investigation To Assess The Safety And Performance Of Disc Care To Prevent Lumbar Disc Herniation Recurrence","ACE-2","Inclusion Criteria:\n\n* Subject is between 18 and 75 years old.\n* Posterolateral disc hernia between levels L4 and S1 with radiological (CT scan or MRI) confirmation of neural compression.\n* At least six weeks of failed conservative treatment prior to surgery, including physical therapy, use of anti-inflammatory medications at maximum specified dosage and\u002For administration of epidural\u002Ffacet injections.\n* Minimum posterior disc height of 5 mm at the index level.\n* Radiculopathy with positive straight leg raise test.\n* ODI score of at least 30\u002F100.\n* Subjects who are able to give voluntary informed consent to participate in the clinical investigation and from whom consent has been obtained.\n* Subject is able and willing to comply with the protocol requirements.\n\nExclusion Criteria:\n\n* Spondylolisthesis and\u002For instability at the index level that, in the judgement of the surgeon, could affect the device implantation.\n* Central, foraminal or extraforaminal disc hernia.\n* Subject has vertebral bodies of the index level affected by any traumatic, neoplastic, metabolic, or infectious pathology.\n* Subject has scoliosis of greater than 20 degrees (both angular and rotational).\n* Grossly distorted anatomy due to congenital abnormalities.\n* Deformation that affects the posterior corners of the vertebra at the index level (e.g., osteophytes) that, in the judgment of the surgeon, could affect the device implantation.\n* Endplate irregularities that, in the judgment of the surgeon, could affect the device implantation.\n* Prior surgery at the index lumbar vertebral level that, in the judgment of the surgeon, could affect the device implantation.\n* Radiological confirmation of severe facet joint disease or degeneration.\n* Patients diagnosed or at a high risk of osteoporosis (such as postmenopausal women and patients receiving long-term treatment with corticosteroids) who present a bone densitometry DXA (dual energy x-ray absorptiometry) T-score of less than -2.0 at the index level.\n* Cauda equina syndrome.\n* Fever, leucocytosis and\u002For systemic or localized active infection.\n* Systemic inflammation and\u002For inflammation at the implantation site.\n* Any uncontrolled metabolic bone disease that affects the spine.\n* Uncontrolled insulin-dependent diabetes mellitus.\n* Peripheral neuropathy.\n* Active hepatitis, AIDS or HIV.\n* Rheumatoid arthritis or other autoimmune disease that affects the spine joints.\n* Active or history of any invasive malignancy; patients with curatively-treated malignancies who have been disease-free for at least 5 years are eligible.\n* Uncontrolled active tuberculosis or history of uncontrolled tuberculosis in the past 3 years.\n* Immunologically suppressed patients.\n* Current anticoagulation therapy, unless anticoagulation therapy can be suspended for surgery.\n* Patients who have received medication (e.g., methotrexate, alendronate) that interferes with bone mineral metabolism within 4 weeks of the planned date of the index surgery.\n* Suspected or known allergies or intolerance to the device materials: titanium, nitinol, stainless steel, polyetheretherketone and polyethylene terephthalate.\n* Any condition that precludes the use of general anaesthesia.\n* Any condition that precludes the surgical procedure.\n* Any contraindication for MRI or CT scan.\n* Class III obesity: Body mass index ≥ 40.\n* Current alcohol or recreational drug dependency.\n* Pregnant or interested in becoming pregnant in the following 24 months.\n* Breastfeeding.\n* Life expectancy less than 2 years.\n* Subject is currently participating or has participated in the previous 4 weeks in any other interventional clinical study.","75 Years",{"count":50,"type":21},30,[24],"The goal of this clinical investigation is to learn about DISC Care, an Hernia Blocking System, in patients who have undergone lumbar disc hernia surgery. The main questions it aims to answer are:\n\n* if the implant (DISC Care) prevents disc herniation recurrence\n* if DISC Care is a safe device\n\nParticipants will be implanted with DISC Care and followed up for two years (7 visits).",[54,55],"Disc Herniation","Disk Herniated Lumbar","RECRUITING","2026-01-09",{"date":59,"type":32},"2026-01-12",{"date":61,"type":32},"2023-11-30",{"date":63,"type":21},"2028-06",{"name":38,"class":39},7,""]