[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640127":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":50,"centralContacts":54,"locations":36,"responsibleParty":60,"collaborators":62,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":36,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":36,"enrollmentInfo":74,"targetDuration":36,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":36,"overallStatus":86,"whyStopped":36,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":36},{"fullName":5,"class":6},"National and Kapodistrian University of Athens","OTHER",[8,16,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"GROUP A","EXPERIMENTAL","(MSCs + PRP): 1 ml of a mixture of subacromial bursa and 3 ml of PRP will be placed in the bone-tendon junction after completion of the arthroscopic suturing",[13,14,15],"Biological: Subacromial Bursa Tissue Reimplantation","Procedure: Arthroscopic Rotator Cuff Repair","Biological: Platelet-Rich Plasma (PRP) Injections",{"label":17,"type":10,"description":18,"interventionNames":19},"GROUP B","1 ml of a mixture of subacromial bursal tissue fragments without PRP will be placed at the bone-tendon junction immediately after completion of the arthroscopic repair.",[13,14],{"label":21,"type":10,"description":22,"interventionNames":23},"GROUP C","3 ml of PRP will be placed at the bone-tendon junction immediately after completion of the arthroscopic repair.",[14,15],{"label":25,"type":26,"description":27,"interventionNames":28},"GROUP D","PLACEBO_COMPARATOR","3 ml of saline will be placed at the bone-tendon junction immediately after completion of the arthroscopic repair.",[14,29],"Other: Normal Saline (0.9% NaCl)",[31,37,42,46],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"BIOLOGICAL","Subacromial Bursa Tissue Reimplantation","Autologous minced subacromial bursal tissue harvested arthroscopically using a tissue collection device and applied at the bone-tendon interface immediately after rotator cuff repair.",[9,17],null,{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":36},"PROCEDURE","Arthroscopic Rotator Cuff Repair","Standard arthroscopic repair of full-thickness isolated supraspinatus tendon tears using suture anchors.",[9,17,21,25],{"type":32,"name":43,"description":44,"armGroupLabels":45,"otherNames":36},"Platelet-Rich Plasma (PRP) Injections","Autologous platelet-rich plasma prepared from preoperatively collected peripheral blood and applied at the bone-tendon interface immediately after repair completion.",[9,21],{"type":6,"name":47,"description":48,"armGroupLabels":49,"otherNames":36},"Normal Saline (0.9% NaCl)","Three milliliters of sterile normal saline applied at the bone-tendon interface immediately after arthroscopic rotator cuff repair as placebo comparator.",[25],[51],{"name":52,"affiliation":36,"role":53},"Andriani Zafeiri","PRINCIPAL_INVESTIGATOR",[55],{"name":56,"role":57,"phone":58,"phoneExt":36,"email":59},"ANDRIANI ZAFEIRI, MEDICAL DOCTOR","CONTACT","+306933398382","andrianizaf@hotmail.com",{"type":53,"investigatorFullName":52,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"MEDICAL DOCTOR",[63],{"name":64,"class":6},"Athens Medical Center","100640127","augmentation-of-arthroscopic-rotator-cuff-repair-with-reimplantation-of-subacromial-bursa-tissue-and-platelet-rich-plasma-100640127",false,"NCT07589478","Augmentation of Arthroscopic Rotator Cuff Repair With Reimplantation of Subacromial Bursa Tissue and Platelet-Rich Plasma","ΕΝΙΣΧΥΣΗ ΑΡΘΡΟΣΚΟΠΙΚΗΣ ΣΥΡΡΑΦΗΣ ΣΤΡΟΦΙΚΟΥ ΠΕΤΑΛΟΥ ΜΕ ΕΠΑΝΕΜΦΥΤΕΥΣΗ ΙΣΤΟΥ ΤΟΥ ΥΠΑΚΡΩΜΙΑΚΟΥ ΘΥΛΑΚΟΥ ΚΑΙ ΠΛΑΣΜΑΤΟΣ ΠΛΟΥΣΙΟΥ ΣΕ ΑΙΜΟΠΕΤΑΛΙΑ","Inclusion Criteria Adult patients aged ≥18 years. Patients undergoing arthroscopic rotator cuff repair. Patients with a full-thickness, isolated, primary tear of the supraspinatus tendon.\n\nPatients considered eligible for arthroscopic rotator cuff repair using suture anchors.\n\nAbility and willingness to provide written informed consent. Willingness and ability to comply with the study protocol and scheduled follow-up visits.\n\nExclusion Criteria Partial-thickness rotator cuff tears. Massive or irreparable rotator cuff tears. Revision rotator cuff repair. Concomitant tears of the subscapularis tendon, infraspinatus tendon, long head of the biceps tendon requiring surgical treatment, or glenoid labrum.\n\nPrevious surgery on the affected shoulder. Glenohumeral osteoarthritis or advanced cuff tear arthropathy. Active infection or systemic inflammatory disease affecting the shoulder. Use of other biological augmentation techniques during surgery, such as collagen patch, stem cells, bone marrow aspirate concentrate, or other scaffold-based augmentation.\n\nInability to provide informed consent. Inability or unwillingness to comply with the postoperative rehabilitation protocol or follow-up schedule.","ALL","18 Years",{"count":75,"type":76},200,"ESTIMATED","INTERVENTIONAL",[79],"NA","The goal of this observational study is to evaluate the clinical and radiographic outcomes of the biological enhancement of the arthroscopic rotator cuff repair with stem cells from the acromial bursa and PRP in individuals who undergo arthroscopic cuff repair The main question it aims to answer is:\n\nDo the stems cells from the acromial bursa and PRP promote healing and produce better results in arthroscopic cuff repair? Researchers will compare this population to three others the first do bnot receive any biological enchancement, the second receive only stem cells and the third receive only PRP to see if there are any differences.",[82,83,84,85],"Cuff Injury, Rotator","Arthroscopic Surgical Procedures","Stem Cell","PRP","NOT_YET_RECRUITING","2026-05-17",{"date":89,"type":90},"2026-05-19","ACTUAL",{"date":92,"type":76},"2026-05",{"date":94,"type":76},"2028-02",{"name":5,"class":6}]