[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100476725":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":44,"responsibleParty":63,"collaborators":42,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":42,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":42,"enrollmentInfo":75,"targetDuration":42,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":42,"overallStatus":46,"whyStopped":42,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Stanford University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BioBrace Augmentation","EXPERIMENTAL","During the shoulder replacement surgery (arthroplasty) in order to access the shoulder, the subscapularis is removed from its insertion in your upper arm bone. It is repaired in reverse total shoulder arthroplasty, but is sometimes not as robust as we would like based on tissue quality and other factors. A shoulder arthroplasty is when the ball and socket are replaced with prosthetic components. If randomized to the BioBrace, patient will receive BioBrace augmentation of the standard subscapularis repair.",[13],"Device: BioBrace Augmentation",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Repair with Sutures","ACTIVE_COMPARATOR","During the shoulder replacement surgery (arthroplasty) in order to access the shoulder, the subscapularis is removed from its insertion in your upper arm bone. It is repaired in reverse total shoulder arthroplasty, but is sometimes not as robust as we would like based on tissue quality and other factors. A shoulder arthroplasty is when the ball and socket are replaced with prosthetic components. If randomized to standard repair, patient will receive the standard repair with sutures.",[19],"Procedure: Standard Repair with Sutures",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","During shoulder replacement surgery, the subscapularis (rotator cuff muscle) is sometimes repaired back again. This will be stitched and augmented with a BioBrace. The Biobrace is a biocomposite scaffold meaning both synthetic and biologic, compared to other traditional implants that are either synthetic or biologic. The stitch in the BioBrace group will be anchored to and reinforced by this material.",[9],[26],"Implant Group",{"type":28,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"PROCEDURE","During shoulder replacement surgery, the Subscapularis (rotator cuff muscle) is sometimes repaired back again. This is usually repaired with stitches per standard of care treatment.",[15],[32],"Stitch Group",[34],{"name":35,"affiliation":5,"role":36},"Michael T Freehill, MD","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Jessica Nguyen","CONTACT","650-725-0003",null,"jessn16@stanford.edu",[45],{"facility":5,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Redwood City","California","94063","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-122.23635,37.48522,{"lat":56,"lon":55},[59,61],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":60},"jessn16@@stanford.edu",{"name":62,"role":36,"phone":42,"phoneExt":42,"email":42},"Michael Freehill, MD",{"type":36,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Michael T. Freehill","Associate Professor of Orthopaedic Surgery","100476725","subscapularis-repair-augmentation-for-total-shoulder-arthroplasty-100476725",false,"NCT05487677","Subscapularis Repair Augmentation for Total Shoulder Arthroplasty","Augmentation of Subscapularis Repair in Total Shoulder Arthroplasty","Inclusion Criteria:\n\n* Total Shoulder Arthroplasty\n\nExclusion Criteria:\n\n* Vulnerable population","ALL","18 Years",{"count":76,"type":77},100,"ESTIMATED","INTERVENTIONAL",[80],"NA","The primary purpose of this research is to compare the images obtained by ultrasound between a standard repair of the subscapularis tissue and after repair with a Biobrace. The secondary purpose is to determine if there are any clinical differences.",[83],"Shoulder Injuries","2026-02-27",{"date":86,"type":87},"2026-03-03","ACTUAL",{"date":89,"type":87},"2023-12-01",{"date":91,"type":77},"2028-12-01",{"name":5,"class":6},1]