[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586643":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":99,"collaborators":20,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":20,"eligibilityCriteria":106,"healthyVolunteers":103,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":20,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":121,"overallStatus":24,"whyStopped":20,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"ZuriMED Technologies Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Augmentation of Rotator Cuff Repair using the FiberLocker® System","EXPERIMENTAL","All enrolled participants will undergo repair of the rotator cuff tear, with augmentation utilizing the FiberLocker® System.",[13],"Device: FiberLocker® System (encompassing FiberLocker® Instrument SN & SpeedPatch® PET)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","FiberLocker® System (encompassing FiberLocker® Instrument SN & SpeedPatch® PET)","The FiberLocker® System is a mechanical augmentation system that includes an implant (SpeedPatch® PET) and an instrument (FiberLocker® Instrument SN) for its attachment. The implant is composed of non-woven PET fibers, and the instrument features a reciprocating needle at its tip, which pushes the individual patch fibers into the underlying tendon tissue.",[9],null,[22,48,65,82],{"facility":23,"status":24,"city":25,"state":26,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"Rush University Medical Center","RECRUITING","Chicago","Illinois","60612","United States","US",{"type":31,"coordinates":32},"Point",[33,34],-87.65005,41.85003,{"lat":34,"lon":33},[37,42,45],{"name":38,"role":39,"phone":40,"phoneExt":20,"email":41},"Ryan Lee","CONTACT","312-432-2337","nicholson.research@rushortho.com",{"name":43,"role":44,"phone":20,"phoneExt":20,"email":20},"Nikhil N Verma, MD","PRINCIPAL_INVESTIGATOR",{"name":46,"role":47,"phone":20,"phoneExt":20,"email":20},"Grant E Garrigues, MD","SUB_INVESTIGATOR",{"facility":49,"status":24,"city":50,"state":51,"zip":52,"country":28,"countryCode":29,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"MedStar Health Research Institute","Columbia","Maryland","21044",{"type":31,"coordinates":54},[55,56],-76.83942,39.24038,{"lat":56,"lon":55},[59,63],{"name":60,"role":39,"phone":61,"phoneExt":20,"email":62},"Crisanto Macaraeg","410-261-8218","crisanto.l.macaraeg@medstar.net",{"name":64,"role":44,"phone":20,"phoneExt":20,"email":20},"Anand Murthi, MD",{"facility":66,"status":24,"city":67,"state":68,"zip":69,"country":28,"countryCode":29,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Wake Forest University","Winston-Salem","North Carolina","27157",{"type":31,"coordinates":71},[72,73],-80.24422,36.09986,{"lat":73,"lon":72},[76,80],{"name":77,"role":39,"phone":78,"phoneExt":20,"email":79},"Rebecca Keith","336-716-5868","Becky.Keith@Advocatehealth.org",{"name":81,"role":44,"phone":20,"phoneExt":20,"email":20},"Brian R Waterman, MD",{"facility":83,"status":24,"city":84,"state":85,"zip":86,"country":28,"countryCode":29,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Southern Oregon Orthopedics Research Foundation","Medford","Oregon","97504",{"type":31,"coordinates":88},[89,90],-122.87559,42.32652,{"lat":90,"lon":89},[93,97],{"name":94,"role":39,"phone":95,"phoneExt":20,"email":96},"Lindsey Chin","541-608-2572","lindseyc@sooresearch.net",{"name":98,"role":44,"phone":20,"phoneExt":20,"email":20},"Patrick Denard, MD",{"type":100,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100586643","fiberlocker-system-augmentation-of-rotator-cuff-repairs-100586643",false,"NCT06918041","FiberLocker® System Augmentation of Rotator Cuff Repairs","Inclusion Criteria:\n\n1. The Subject is between the ages of 30 and 70 years.\n2. Subject is planning to undergo arthroscopic surgery for full-thickness rotator cuff tear (RCT)\n3. Tear size ≥ 2 cm\n4. Primary rotator cuff repair\n5. Subject preoperative MRI obtained within 1 year prior to surgery\n\nExclusion Criteria:\n\n1. The Subject is unable or unwilling to sign the Patient Informed Consent, approved by the Institutional Review Board.\n2. The Subject objects to the use of the FiberLocker® System\n3. History or known allergy or intolerance to polyester\n4. Complete full-thickness subscapularis tears of \\> than the superior 1\u002F3 of the tendon (Lafosse grade 3 and above)\n5. Hamada grade III and above\n6. Less than 2 mm joint space of the glenohumeral joint on either an anteroposterior or axillary radiograph\n7. Recurrent shoulder instability\n8. Corticosteroid injection in the operative shoulder within three months before surgery\n9. Subjects with inflammatory or auto-immune based joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus)\n10. Subjects with current acute infection in the area surrounding the surgical site\n11. Revision rotator cuff repair\n12. Pregnant or planning to become pregnant during the study period\n13. Subject is breastfeeding during the study period\n14. Subject has conditions or circumstances that would interfere with study requirements\n\nIntraoperative Exclusion Criteria:\n\n1. Partial rotator cuff repairs\n2. Lafosse grade 3 or higher subscapularis tears\n3. Limited space for implant delivery\n4. FiberLocker® System cannot be used as indicated","ALL","30 Years","70 Years",{"count":111,"type":112},60,"ESTIMATED","INTERVENTIONAL",[115],"NA","The purpose of this study is to prospectively evaluate healing, functional clinical outcomes, and safety of arthroscopic rotator cuff repairs augmented with the FiberLocker® System (encompassing the SpeedPatch® PET and the FiberLocker® Instrument SN).\n\nThe primary outcome measure is healing evaluation based on Magnetic Resonance Imaging (MRI) at a minimum of 6 months post-operatively.\n\nThe secondary outcome measures are the Sugaya classification, Goutallier Stage and tendon quality based on MRI as well as objective scores and patient-reported outcome measures (PROMs) from validated outcome scoring systems.",[118,119,120],"Rotator Cuff Tear","Rotator Cuff Tears","Rotator Cuff Tears of the Shoulder",[119,122,123,124,125,126],"Rotator Cuff Repair","Augmentation","Reinforcement","Mechanical Augmentation","Rotator Cuff Degeneration","2025-11-27",{"date":129,"type":130},"2025-12-01","ACTUAL",{"date":132,"type":130},"2025-08-05",{"date":134,"type":112},"2028-04-01",{"name":5,"class":6},4]