[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100473050":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":40,"centralContacts":45,"locations":53,"responsibleParty":71,"collaborators":27,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":27,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":27,"enrollmentInfo":83,"targetDuration":27,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":55,"whyStopped":27,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Henry Ford Health System","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Group","ACTIVE_COMPARATOR","Surgical treatment alone, consisting of arthroscopic rotator cuff repair. Ultrasound postoperatively at 1 year.",[13,14],"Procedure: arthroscopic rotator cuff repair","Diagnostic Test: Ultrasound Imaging",{"label":16,"type":17,"description":18,"interventionNames":19},"Study Group","EXPERIMENTAL","Identical surgical treatment as control group plus bio-inductive patch implant. Ultrasound postoperatively at 1 year.",[13,20,14],"Biological: Bioinductive implant",[22,28,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"PROCEDURE","arthroscopic rotator cuff repair","This procedure is the standard of care for rotator cuff tears who fail conservative treatment options.",[9,16],null,{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"BIOLOGICAL","Bioinductive implant","A bioinductive implant that is designed to promote healing of the torn rotator cuff tendon after surgery.",[16],[34],"Bioinductive patch",{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":27},"DIAGNOSTIC_TEST","Ultrasound Imaging","An ultrasound will be performed on each patient one year postoperatively.",[9,16],[41],{"name":42,"affiliation":43,"role":44},"Stephanie J Muh, MC","Henry Ford Health","PRINCIPAL_INVESTIGATOR",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":27,"email":50},"Johnny Kasto, MD","CONTACT","313-244-8078","jkasto1@hfhs.org",{"name":52,"role":48,"phone":27,"phoneExt":27,"email":27},"Stephanie J Muh, MD",[54],{"facility":43,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"RECRUITING","Detroit","Michigan","48202","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-83.04575,42.33143,{"lat":65,"lon":64},[68,70],{"name":47,"role":48,"phone":69,"phoneExt":27,"email":50},"3132448078",{"name":52,"role":44,"phone":27,"phoneExt":27,"email":27},{"type":44,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Stephanie Muh, MD","Deputy Service Chief, Principal Investigator","100473050","phase-4-bioinductive-patch-for-full-thickness-rotator-cuff-tears-100473050",false,"NCT05439850","Bioinductive Patch for Full-Thickness Rotator Cuff Tears","Arthroscopic Rotator Cuff Repair Augmented With Bioinductive Implant for Full-Thickness Tears: A Randomized Controlled Study","Inclusion Criteria:\n\n* Indicated and scheduled for arthroscopic rotator cuff repair.\n* Full-thickness medium (1-3 cm), large (3-5 cm), and massive (\\>5 cm) rotator cuff tears involving the supraspinatus and\u002For infraspinatus tendons demonstrated on magnetic resonance or ultrasound imaging.\n* Chronic, degenerative rotator cuff tears.\n* Ability to read and understand English.\n* Age ≥18 years\n* Patient failed ≥6 weeks of conservative treatment, which included structured, in-person physical therapy or documented home therapy\n\nExclusion Criteria:\n\n* Patient scheduled for open or mini-open rotator cuff repair\n* Prior surgery of affected shoulder (except diagnostic arthroscopy)\n* Partial-thickness rotator cuff tears\n* Small (\\\u003C1 cm) rotator cuff tears\n* Rotator cuff tears involving the subscapularis tendon\n* Acute and traumatic rotator cuff tears\n* Active infection\n* Cancer\n* Autoimmune and rheumatologic disorders, including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus","ALL","18 Years",{"count":84,"type":85},78,"ESTIMATED","INTERVENTIONAL",[88],"PHASE4","The purpose of this randomized-controlled study is to compare outcomes of arthroscopic rotator cuff repair augmented with a Bioinductive Implant (study group) to standard arthroscopic rotator cuff repair (control group). The primary outcome of this study is rotator cuff repair integrity (absence of full- or partial-thickness defect) demonstrated on ultrasound at 1-year postoperatively. The investigators hypothesize that the study group will have higher rates of repair integrity demonstrated on ultrasound at 1-year postoperatively.",[91,92],"Rotator Cuff Tears","Rotator Cuff Tear Arthropathy",[94,95,96,92],"Rotator Cuff Tear","Bioinductive","Arthroscopic Rotator Cuff Repair","2026-02-24",{"date":99,"type":100},"2026-02-27","ACTUAL",{"date":102,"type":100},"2022-08-16",{"date":104,"type":85},"2029-07-01",{"name":5,"class":6},1]