[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100512998":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":57,"collaborators":59,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":25,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":25,"enrollmentInfo":72,"targetDuration":25,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Nova Scotia Health Authority","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Repair","ACTIVE_COMPARATOR","This group will undergo a rotator cuff repair procedure.",[13],"Procedure: Repair",{"label":15,"type":16,"description":17,"interventionNames":18},"Bridging Reconstruction using BioBrace","EXPERIMENTAL","This experimental group will undergo bridging reconstruction using the bioinductive implant, BioBrace.",[19],"Procedure: Bridging Reconstruction using BioBrace",[21,26],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Patients in the reconstruction group will undergo maximal repair with interposition bridging using BioBrace. This technique will follow a previously described technique by the principal investigator with differences allocated to the graft, it's preparation and insertion. The bursa will be debrided, and rotator cuff edged will be shaved down to stable tissue. BioBrace is bioinductive scaffold composed of highly porous type I collagen and bio-resorbable poly (L-lactide) (PLLA) microfilaments, and will be used as the graft in this trial.",[15],null,{"type":22,"name":9,"description":27,"armGroupLabels":28,"otherNames":25},"Patients in the maximal repair group will undergo a SCOI-row rotator cuff repair with adequate tension as described previously, with recreation of the rotator cable. Briefly, the SCOI-row rotator cuff repair uses one triple loaded suture anchor for each 1.2cm of torn tendon. This technique has been completed in a previous randomized controlled trial.",[9],[30],{"name":31,"affiliation":32,"role":33},"Ivan Wong, MD","Nova Scotia Health Authority, Orthopaedic Surgeon","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Sarah Remedios, MSc","CONTACT","9024737626","research@drivanwong.com",[41],{"facility":5,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Halifax","Nova Scotia","B3H2E1","Canada","CA",{"type":49,"coordinates":50},"Point",[51,52],-63.57688,44.64269,{"lat":52,"lon":51},[55],{"name":56,"role":37,"phone":38,"phoneExt":25,"email":39},"Ivan Wong",{"type":33,"investigatorFullName":31,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"MD Orthopaedic Surgeon",[60],{"name":61,"class":62},"CONMED Corporation","INDUSTRY","100512998","maximal-repair-versus-bridging-reconstruction-with-biobrace-100512998",false,"NCT05959733","Maximal Repair Versus Bridging Reconstruction with BioBrace®","Maximal Repair Versus Bridging Reconstruction with BioBrace® for the Treatment of Chronic, Massive Rotator Cuff Tears: Clinical, Radiographic, and In-vivo Biomechanical Analysis","Inclusion Criteria:\n\n* magnetic resonance imaging (MRI) proven diagnosis of a large or massive (\\> 3cm), two-tendon (supraspinatus and infraspinatus) tear of the shoulder rotator cuff\n* over 18 years of age\n\nExclusion Criteria:\n\n* glenohumeral osteoarthritis\n* Western Ontario rotator cuff score \\>60\n* uncontrolled diabetes (Hgb A1C \\>7%)\n* pregnant\n* local or systemic infection\n* inability to cooperate with and\u002For comprehend post-operative instructions\n* MRI proven non-vascular sites\n* poor nutritional state (Alb \\\u003C30 g\u002FL)\n* cancer\n* paralysis of the shoulder\n* contracture of the shoulder\n* patients unable to provide informed consent for the study","ALL","18 Years",{"count":73,"type":74},60,"ESTIMATED","INTERVENTIONAL",[77],"NA","The purpose of this study is to determine if using BioBrace® to reconstruct the gap in the rotator cuff tears lead to better results for patients compared to the traditional maximal repair method. This study will use a variety of clinical, radiographic, and functional outcome measures. Specifically, the researchers will be comparing the re-tear rate, patient reported outcomes, shoulder strength, range of motion, muscle activation, in-vivo biomechanics, and other radiographic outcomes using x-ray and MRI.",[80,81],"Rotator Cuff Tears","Bioinductive Implant",[83,84,85,86,87,88,89],"shoulder","rotator cuff","clinical outcomes","radiographic outcomes","biomechanics","bridging reconstruction","rotator cuff repair","2025-02-14",{"date":92,"type":93},"2025-02-18","ACTUAL",{"date":95,"type":93},"2023-12-07",{"date":97,"type":74},"2027-07-31",{"name":5,"class":6},1]