[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566823":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":35,"locations":41,"responsibleParty":57,"collaborators":59,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":24,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":24,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":43,"whyStopped":24,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"University Hospitals Cleveland Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Rigid Sternal Fixation","EXPERIMENTAL","The surgeon will close the sternum (breastbone) using the SternalPlate system. The SternalPlate System consists of implants and instruments used to hold the two halves of the sternum together.",[13],"Device: Rigid Sternal Fixation",{"label":15,"type":16,"description":17,"interventionNames":18},"Wire Cerclage","ACTIVE_COMPARATOR","The surgeon will close the sternum (breastbone) using Wire Cerclage. Wire Cerclage consists of stainless steel wires used to hold the two halves of the sternum together.",[19],"Device: Wire Cerclage",[21,25],{"type":22,"name":9,"description":11,"armGroupLabels":23,"otherNames":24},"DEVICE",[9],null,{"type":22,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"The surgeon will close the sternum (breastbone) using Wire Cerclage. Wire Cerclage consists of stainless steel wires used to hold the two halves of your sternum together.",[15],[29,33],{"name":30,"affiliation":31,"role":32},"Marc Pelletier, MD","University Hospitals","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":31,"role":32},"Rakesh Arora, MD",[36],{"name":37,"role":38,"phone":39,"phoneExt":24,"email":40},"Stacey Mazzurco","CONTACT","216-844-3130","Stacey.Mazzurco@UHhospitals.org",[42],{"facility":31,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Cleveland","Ohio","44106","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-81.69541,41.4995,{"lat":53,"lon":52},[56],{"name":37,"role":38,"phone":39,"phoneExt":24,"email":40},{"type":58,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[60],{"name":61,"class":62},"Stryker Nordic","INDUSTRY","100566823","sternal-plating-high-risk-100566823",false,"NCT06660186","Sternal Plating High Risk","Randomized Trial of Rigid Plate Fixation Versus Wire Cerclage in High-Risk Sternotomy Patients","Preoperative Inclusion Criteria\n\n* Adults (age range: 18-89)\n* Undergoing cardiac surgery through sternotomy\n\n  -≥2 risk factors:\n* Diabetes mellitus\n* Severe COPD\n* Chronic steroid use\n* Immunosuppression\n* Redo sternotomy\n* Chronic\n* Kidney disease with GFR \\>30 ml\u002Fmin per 1.73m2\n* Radiation therapy\n* BMI≥35\n* High-risk of delirium\n* Heavy alcohol use\n\nPreoperative Exclusion Criteria\n\n* Active malignancy\n* Chronic narcotic use\n* NYHA Class IV\n* Known nickel metal allergy\n* Compliance concern\n* eGFR\\\u003C30 ml\u002Fmin per 1.73m2\n* Involvement in another interventional clinical trial (non-registry)\n* Any criteria precluding RPF or WC\n\nOperative Inclusion Criteria\n\n* Off-midline sternotomy\n* BITA grafting\n* CPB time ≥120 minutes\n* Transverse sternal fracture\n\nOperative Exclusion Criteria\n\n* Emergent or emergent salvage surgery\n* Non-standard sternotomies\n* Sternotomy with bony margin \\\u003C2 mm\n* Bleeding\n* Delayed sternal closure\n* Surgical complications\n* Any criteria precluding RPF or WC","ALL","18 Years","89 Years",{"count":74,"type":75},250,"ESTIMATED","INTERVENTIONAL",[78],"NA","Participants are being invited to participate in a research study at University Hospitals because they have heart disease and are scheduled for open heart surgery. Currently, UH cardiac surgeons close the sternum (or breastbone) after a sternotomy (procedure that allows a doctor to reach the heart and blood vessels) with either a rigid plate fixation Sternal Plate or a Wire Cerclage. However, the study team would like to further evaluate these two techniques. Any volunteer over the age of 18 who is at an increased risk for developing sternal wound complications may be eligible to participate.",[81],"Heart Diseases",[83,84,9,85,86,87],"Cardiac Surgery","Wound Complication","Sternal Infection","Pain","Non-union","2026-04-24",{"date":90,"type":91},"2026-04-30","ACTUAL",{"date":93,"type":91},"2026-03-12",{"date":95,"type":75},"2027-06-30",{"name":5,"class":6},1]