[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572584":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":39,"responsibleParty":55,"collaborators":25,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":25,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":25,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"University of Minnesota","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"biologic tuberoplasty group","EXPERIMENTAL","massive irreparable rotator cuff tear involving the supraspinatus and infraspinatus, no involvement of the subscapularis, centered humeral head on X-Ray examination, and a primary complaint of pain, randomized to biologic tuberoplasty surgery.",[13],"Procedure: biologic tuberoplasty",{"label":15,"type":10,"description":16,"interventionNames":17},"subacromial balloon spacer group","massive irreparable rotator cuff tear involving the supraspinatus and infraspinatus, no involvement of the subscapularis, centered humeral head on X-Ray examination, and a primary complaint of pain, randomized to subacromial balloon spacer.",[18],"Procedure: subacromial balloon spacer",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","biologic tuberoplasty","a surgical procedure during which an a cellular dermal allograft is attached to the greater tuberosity to prevent bone-to-bone contact between the greater tuberosity and the acromion with the goal of decreasing pain",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"subacromial balloon spacer","a biodegradable balloon is inserted into the subacromial space of the shoulder to increase teh distance between the greater tuberosity and the acromion to reduce pain",[15],[31],{"name":32,"affiliation":5,"role":33},"Allison Rao","PRINCIPAL_INVESTIGATOR",[35],{"name":32,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","608-445-0545","rao00149@umn.edu",[40],{"facility":5,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Minneapolis","Minnesota","55414","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-93.26384,44.97997,{"lat":51,"lon":50},[54],{"name":32,"role":36,"phone":37,"phoneExt":25,"email":38},{"type":56,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100572584","phase-1-tuberoplasty-versus-balloon-spacer-100572584",false,"NCT06735170","Tuberoplasty Versus Balloon Spacer","Tuberoplasty Versus Balloon Spacer in Treatment of Rotator Cuff Tears","Inclusion Criteria:\n\n* Massive irreparable rotator cuff tear involving the supraspinatus and infraspinatus.\n* No involvement of the subscapularis.\n* Centered humeral head on X-ray examination.\n* Primary complaint of pain.\n* History of prior surgery, including failed rotator cuff repair.\n\nExclusion Criteria:\n\n* Involvement of the subscapularis.\n* Acromiohumeral distance less than 7 mm on upright anterior-posterior (AP) radiograph.\n* Rotator cuff deemed repairable at the time of surgery.\n* Patients younger than 65 years due to FDA clearance of the subacromial balloon spacer only for patients over 65","ALL","65 Years",{"count":67,"type":68},40,"ESTIMATED","INTERVENTIONAL",[71,72],"PHASE1","PHASE2","The purpose of this study is to examine bone-to-bone contact between the tuberosity as compared to a subacromial balloon spacer procedure. Using biplanar fluoroscopy to determine the three-dimensional (3D) motion of the shoulder compared pre-procedure to post-procedure, the investigators will be able to assess 1) the bone-to-bone contact of the tuberosity and acromion in the setting of a massive posterior superior rotator cuff tear 2) if the placement of a dermal allograft over the tuberosity does indeed decrease bone contact and 3) if the placement of a subacromial balloon spacer decreases bone-to-bone contact. Doing so will allow assessment of the relative contribution of the implant for arm elevation versus potential compensatory motion of increased scapulothoracic motion. The investigators will also be able to correlate this to patient-reported outcomes of pain and shoulder function.",[75],"Rotator Cuff Tears",[77,78,79,27],"rotator cuff tear","shoulder surgery","tuberoplasty","2026-01-05",{"date":82,"type":83},"2026-01-07","ACTUAL",{"date":85,"type":83},"2024-12-02",{"date":87,"type":68},"2026-11-26",{"name":5,"class":6},1]