[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517353":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":50,"centralContacts":55,"locations":30,"responsibleParty":64,"collaborators":66,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":30,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":30,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":100,"whyStopped":30,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":30},{"fullName":5,"class":6},"Tartu University Hospital","OTHER",[8,15,21,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Arthroscopic rotator cuff partial repair with superior capsule augmentation with LHBBT","EXPERIMENTAL","If a tear is intra-operatively determined irreparable, randomization takes place.\n\nIrreparable tears that are randomly selected to receive arthroscopic rotator cuff partial repair including superior capsular augmentation with proximal part of the long head of the biceps tendon. The long head of the biceps tendon will be released from bicipital groove and proximal part of the tendon will be used to cover the rotator cuff gap and anchored to the greater tuberosity.",[13,14],"Procedure: Arthroscopic rotator cuff partial repair with superior capsular augmentation with LHBBT","Device: Suture anchor(s)",{"label":16,"type":17,"description":18,"interventionNames":19},"Arthroscopic partial rotator cuff repair","ACTIVE_COMPARATOR","If a tear is intra-operatively determined irreparable, randomization takes place.\n\nIrreparable tears that are randomly selected to receive arthroscopic partial repair.",[20,14],"Procedure: Arthroscopic rotator cuff partial repair",{"label":22,"type":6,"description":23,"interventionNames":24},"Arthroscopic rotator cuff repair","Arthroscopic complete repair.",[25,14],"Procedure: Arthroscopic complete rotator cuff repair",{"label":27,"type":28,"description":29,"interventionNames":30},"Rotator cuff tear conservative treatment","NO_INTERVENTION","Conservative treatment following physiotherapy protocol.",null,[32,37,41,45],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":30},"PROCEDURE","Arthroscopic rotator cuff partial repair with superior capsular augmentation with LHBBT","Residual rotator cuff defect will be reconstructed using LHBBT.",[9],{"type":33,"name":38,"description":39,"armGroupLabels":40,"otherNames":30},"Arthroscopic rotator cuff partial repair","Rotator cuff will be repaired with remaining residual defect.",[16],{"type":33,"name":42,"description":43,"armGroupLabels":44,"otherNames":30},"Arthroscopic complete rotator cuff repair","Arthroscopic complete repair as a standard procedure.",[22],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":30},"DEVICE","Suture anchor(s)","Arthroscopic rotator cuff tendon(s) repair using suture anchor(s).",[16,9,22],[51],{"name":52,"affiliation":53,"role":54},"Tiina Tikk, MD","University of Tartu","PRINCIPAL_INVESTIGATOR",[56,61],{"name":52,"role":57,"phone":58,"phoneExt":59,"email":60},"CONTACT","55929399","+372","tiinatikk@gmail.com",{"name":62,"role":57,"phone":30,"phoneExt":30,"email":63},"Madis Rahu, PhD\u002FMD","madis.rahu@regionaalhaigla.ee",{"type":65,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[67],{"name":53,"class":6},"100517353","outcomes-of-massive-rotator-cuff-tendon-tear-treatment-100517353",false,"NCT06016439","Outcomes of Massive Rotator Cuff Tendon Tear Treatment.","Outcomes of Different Treatment Modalities for Massive Rotator Cuff Tendon Tear.","Inclusion Criteria:\n\n* Massive rotator cuff tendon tear: grade III according to Davidson and Burkhart 2010 classification, diagnosed on MRI, and LHBB tendon is intact.\n* Primary rotator cuff pathology AND\n* Symptoms have not lasted more than 6 months.\n* In case of trauma, traumatic event no more than 6 months ago.\n* Aged between 50 and 80 at the time of enrollment.\n* Subject is able and willing to give informed consent AND\n* Subject is physically and mentally willing and able to comply with the post-operative rehabilitation protocol, questionnaires, and scheduled clinical and radiographic visits.\n\nExclusion Criteria:\n\n* Previous rotator cuff surgery of the index shoulder.\n* Acute or chronic osteomyelitis.\n* Inflammatory joint disease (rheumatoid arthritis\u002F (pseudo)gout arthritis).\n* Uncontrolled diabetes.\n* Active oncological disease.\n* Radiologically stage IV shoulder joint arthrosis (rotator cuff arthropathy).\n* Systemic or intra-articular corticosteroid therapy less than 60 days prior to planned operation date.\n* Intramuscular or peroral corticosteroid treatment less than 30 days prior to planned operation date.\n* Acute or chronic conditions that are contraindications for functional testing.\n* MRI contraindicated.\n* Substance or alcohol abuse.\n* Refusal or withdrawal of consent.","ALL","50 Years","80 Years",{"count":79,"type":80},80,"ESTIMATED","INTERVENTIONAL",[83],"NA","Rotator cuff tear is the leading cause of shoulder pain in the elderly. There isn't enough evidence nor clinical guidelines to guide the treatment of massive rotator cuff tears, specially irreparable tears. Arthroscopic partial repair has been widely used and superior capsular reconstruction (SCR), either with allograft, autograft or augmentation with long head biceps brachii tendon (LHBBT), has been recently added. It is showing promising results, but lacking high quality evidence.\n\nThis is a prospective clinical study to compare the outcomes of different surgical methods for massive rotator cuff tendon tears. Minimal follow-up time will be two years. In this trial, massive rotator cuff tears will be anatomically repaired if possible. For irreparable tears a method will be randomly assigned intra-operatively once a tear is determined to be irreparable - either partial repair or partial repair with superior capsular reconstruction using the long head biceps brachii (LHBB) tendon. Patients who are eligible for the study but refuse operative treatment, will serve as conservative study group.\n\nThe hypothesis is that massive rotator cuff tears that are reparable will have the best functional outcomes. For irreparable tears, augmentation with LHBBT will give superior results over partial repair.",[86,87],"Rotator Cuff Tears","Rotator Cuff Syndrome",[89,90,91,92,93,94,95,96,97,98,99],"rotator cuff injury","rotator cuff tears","massive","shoulder","shoulder injuries","superior capsular reconstruction","long head of biceps tendon","irreparable","tear","rupture","partial repair","NOT_YET_RECRUITING","2023-11-22",{"date":103,"type":104},"2023-11-24","ACTUAL",{"date":106,"type":80},"2024-01",{"date":108,"type":80},"2033-12",{"name":5,"class":6}]