[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522000":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":42,"responsibleParty":58,"collaborators":32,"id":60,"slug":32,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":32,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":32,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":44,"whyStopped":32,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Spital Thurgau AG","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment group with patch augmentation","EXPERIMENTAL","Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch",[13],"Device: Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch (Pitch-Patch Tissue Reinforcement Device))",{"label":15,"type":16,"description":17,"interventionNames":18},"Comparison group without patch augmentation","ACTIVE_COMPARATOR","Arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch",[19],"Device: Arthroscopic rotator cuff reconstruction using fixation with anchors augmented without a synthetic polyester patch",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch (Pitch-Patch Tissue Reinforcement Device))","The Pitch-Patch is a single-use device intended to reinforce the rotator cuff following or during repair by sutures or suture anchors where weakness exists in the soft tissue.",[9],[27],"Pitch-Patch Tissue Reinforcement Device (version model number 102-1090)",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Arthroscopic rotator cuff reconstruction using fixation with anchors augmented without a synthetic polyester patch","Arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch.",[15],null,[34],{"name":35,"affiliation":5,"role":36},"Florian Hess, MD","PRINCIPAL_INVESTIGATOR",[38],{"name":35,"role":39,"phone":40,"phoneExt":32,"email":41},"CONTACT","+41 58 144 8143","florian.hess@stgag.ch",[43],{"facility":5,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Frauenfeld","Thurgau","8501","Switzerland","CH",{"type":51,"coordinates":52},"Point",[53,54],8.89893,47.55776,{"lat":54,"lon":53},[57],{"name":35,"role":39,"phone":40,"phoneExt":32,"email":41},{"type":59,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100522000",false,"NCT06076902","Patch Study (Patch-augmented Rotator Cuff Repair)","Patch Study: a Single-center, Prospective, Single-blind, Randomized, Two-arm Controlled Study of Outcomes Following Synthetic Polyester Patch-augmented Rotator Cuff Repair","Inclusion Criteria:\n\n* Adults with massive rotator cuff tear\n* Tear must affect at least two tendons\n* Primary surgery only\n* Origin of tear can be either degenerative or traumatic\n* German language speaking\n\nExclusion Criteria:\n\n* Fatty infiltration grade 4 (according to Goutallier)\n* Bilateral tears\n* Cases of arthritis or severe osteoarthritis\n* Structural or pathological condition of the bone or soft tissue that could impair healing\n* Unable or unwilling to restrict activities to prescribed levels or follow rehabilitation guidelines\n* Unable or unwilling to give consent (language barrier or cognitive impairment)\n* Unwilling or unable to be assessed at 1- and 2-year follow-up assessment visits","ALL","30 Years","75 Years",{"count":70,"type":71},300,"ESTIMATED","INTERVENTIONAL",[74],"NA","This single-center, prospective, randomized controlled study will compare patients allocated to two treatment arms who are undergoing surgery to repair rotator cuff tears: (1) arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch, and (2) arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch. The primary objective is to compare complications (primarily retear rates) and the secondary objective is to compare mid- and long-term clinical and radiological outcomes using standard orthopedic assessments, such as the subjective shoulder value and the Constant-Murley score.",[77],"Rotator Cuff Tears",[79],"Rotator Cuff Repair","2023-10-04",{"date":82,"type":83},"2023-10-11","ACTUAL",{"date":85,"type":83},"2023-04-06",{"date":87,"type":71},"2027-04-30",{"name":5,"class":6},1]