[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621098":3},{"organization":4,"outcomesModule":7,"designInfo":84,"detailedDescription":83,"studyPopulation":83,"armGroups":93,"interventions":106,"overallOfficials":83,"centralContacts":115,"locations":83,"responsibleParty":121,"collaborators":123,"id":127,"slug":83,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":128,"sex":134,"minAge":135,"maxAge":83,"enrollmentInfo":136,"targetDuration":83,"studyType":139,"phases":140,"briefSummary":142,"conditions":143,"keywords":83,"overallStatus":145,"whyStopped":83,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":83},{"fullName":5,"class":6},"NEOS Surgery","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":83},[9],{"measure":10,"description":11,"timeFrame":12},"Sternal stability","Sternal stability measured by clinical assessment using the sternal instability scale (SIS), with grades 0 to 3 where 0 is \"Clinically stable sternum\" and 3 is \"Completely separated sternum - entire length\"","1 month post operatively",[14,18,22,26,30,34,37,41,45,49,53,56,60,64,68,72,75,79],{"measure":15,"description":16,"timeFrame":17},"Safety of the SC03 Plating System","Incidence of Device Deficiencies, AE and SAE with a possible, probable or causal relationship with the device or the procedure.","Perioperative, 1 month and 6 months postoperatively.",{"measure":19,"description":20,"timeFrame":21},"Reinterventions","Incidence and cause of surgical reinterventions","1 month and 6 months postoperatively",{"measure":23,"description":24,"timeFrame":25},"Infections","Incidence of sternal superficial and deep wound infections (mediastinitis)","First month and six months postoperatively.",{"measure":27,"description":28,"timeFrame":29},"Sternal dehiscence","Incidence of sternal dehiscence (without infection)","First month and six months postoperatively",{"measure":31,"description":32,"timeFrame":33},"Sternotomy closure duration","Duration of sternotomy closure procedure (minutes)","Surgery",{"measure":35,"description":36,"timeFrame":33},"Easiness of use of the closure method","Surgeon-reported ease of use and satisfaction score (Likert Scale, from 1 to 5)",{"measure":38,"description":39,"timeFrame":40},"Sternal Pain","Patient-reported sternal pain at rest and during forced cough, measured by Numerical Rating Scale (0-10)","Baseline, 7 days, 1 month and 6 months postoperatively.",{"measure":42,"description":43,"timeFrame":44},"Analgesia required","Type and cumulative dose of analgesia (total morphine milligram equivalents (MME))","Day 7, 1 month and 6 months postoperatively",{"measure":46,"description":47,"timeFrame":48},"Post-surgery blood loss","Chest tube drainage (mL)","12 hours postoperatively",{"measure":50,"description":51,"timeFrame":52},"Blood loss","Haemoglobin drop (g\u002FdL)","48 hours after surgery",{"measure":50,"description":54,"timeFrame":55},"Number of administered perioperative blood transfusions of packed red blood cells","48 hour after surgery",{"measure":57,"description":58,"timeFrame":59},"Intensive Care Unit stay duration","Intensive Care Unit stay duration (hours)","from surgery date to Intensive care unit discharge date (up to 150 days)]",{"measure":61,"description":62,"timeFrame":63},"hospitalization duration","hospitalization duration (days)","from surgery date to hospital discharge date (up to 150 days)",{"measure":65,"description":66,"timeFrame":67},"sternal stability","Sternal stability clinically assessed with the sternal instability scale (from 0 to 3)","7 days and 6 months postoperatively",{"measure":69,"description":70,"timeFrame":71},"Upper Limb functional index","Patients will assess their upper limbs functional capacity using the Upper Limb functional index (ULFI-Sp)","Before surgery, one month and 6 months postoperatively",{"measure":73,"description":74,"timeFrame":71},"Quality of life - EQ5D5L","Patients will complete the EQ-5D-5L questionnaire",{"measure":76,"description":77,"timeFrame":78},"Chest bulging","Presence of visible bulging related to the sternal closure method on the sternotomy area","1 month after surgery",{"measure":80,"description":81,"timeFrame":82},"Pulmonary function","Pulmonary function (FVC, FEV1 and FEV1\u002FFVC) measured by spirometry","Baseline, day 7 and 1 month postoperatively",null,{"allocation":85,"interventionModel":86,"interventionModelDescription":83,"primaryPurpose":87,"observationalModel":83,"timePerspective":83,"maskingInfo":88},"RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":89,"maskingDescription":83,"whoMasked":90},"DOUBLE",[91,92],"PARTICIPANT","OUTCOMES_ASSESSOR",[94,100],{"label":95,"type":96,"description":97,"interventionNames":98},"SC03 plates","EXPERIMENTAL","Adjustable carbon fiber sternal plates",[99],"Device: SC03 Plating system",{"label":101,"type":102,"description":103,"interventionNames":104},"Wires","ACTIVE_COMPARATOR","Stainless steel sternal wires",[105],"Device: Stainless steel wires",[107,111],{"type":108,"name":109,"description":97,"armGroupLabels":110,"otherNames":83},"DEVICE","SC03 Plating system",[95],{"type":108,"name":112,"description":113,"armGroupLabels":114,"otherNames":83},"Stainless steel wires","Nonabsorbable, sterile, surgical sutures used in sternal closure",[101],[116],{"name":117,"role":118,"phone":119,"phoneExt":83,"email":120},"Laia Rofes, PhD","CONTACT","+34935944726","lrofes@neosurgery.com",{"type":122,"investigatorFullName":83,"investigatorTitle":83,"investigatorAffiliation":83,"oldNameTitle":83,"oldOrganization":83},"SPONSOR",[124],{"name":125,"class":126},"Fundacio Privada Mon Clinic Barcelona","OTHER","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":137,"type":138},190,"ESTIMATED","INTERVENTIONAL",[141],"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",[144],"Sternotomy Closure,Open Heart Surgery","NOT_YET_RECRUITING","2026-01-16",{"date":148,"type":149},"2026-01-26","ACTUAL",{"date":151,"type":138},"2026-02",{"date":153,"type":138},"2027-12",{"name":5,"class":6}]