[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593332":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":42,"collaborators":20,"id":44,"slug":20,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":45,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":20,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":24,"whyStopped":20,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"ZuriMED Technologies AG","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 SpeedPatch® PET and FiberLocker Instrument® SN)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","FiberLocker® System (encompassing SpeedPatch® PET and FiberLocker Instrument® SN)","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],{"facility":23,"status":24,"city":25,"state":26,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"Balgrist University Hospital","RECRUITING","Zurich","Canton of Zurich","8008","Switzerland","CH",{"type":31,"coordinates":32},"Point",[33,34],8.55,47.36667,{"lat":34,"lon":33},[37],{"name":38,"role":39,"phone":40,"phoneExt":20,"email":41},"Karl Wieser, Prof. Dr. med.","CONTACT","+41 44 386 30 12","schulter@balgrist.ch",{"type":43,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100593332",false,"NCT07005063","Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation","Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation: A Prospective, Single-Arm, Non-Randomized, Pilot Study","FIBERLOCK","Inclusion Criteria:\n\n1. Subject requires surgical treatment of a full-thickness rotator cuff tear, according to Balgrist standard procedure\n2. Full-thickness tear of the supraspinatus or combined infraspinatus and supraspinatus\n3. The rotator cuff tear is of traumatic origin.\n4. Subject is ≥ 40 years of age \\& ≤ 65 years of age.\n5. Primary rotator cuff repair\n6. Informed Consent signed by the subject\n7. Pre-operative MRI performed\n\nExclusion Criteria:\n\n1. Vulnerable subjects (as defined in ISO 14155)\n2. Subjects who do not have the power of judgement or are unable to fully understand all aspects of the investigation that are relevant to the decision to participate\n3. Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation,\n4. Previous enrolment into the current investigation,\n5. Enrolment of the PI, his\u002Fher family members, employees and other dependent persons,\n6. Inability to follow the procedures of the investigation, or known or suspected non-compliance, e.g. due to language problems, psychological disorders, dementia, drug or alcohol abuse, etc. of the subject\n7. Active smoker\n8. History of claustrophobia that would prevent an MRI of the index shoulder\n9. Presence of an implanted metallic device or other implants that would contraindicate acquisition or inhibit radiologist review of an MRI of the index shoulder\n10. Pregnant or planning to become pregnant during the study period\n11. Breast feeding women\n12. Subject has conditions or circumstances that would interfere with study requirements.\n13. Contraindications and limitations of the MD as described in the IFUs.\n14. Partial rotator cuff tears\n15. History or known allergy or intolerance to polyester\n16. Complete full-thickness subscapularis tears greater than the superior 1\u002F3 of the tendon, with Lafosse grade 3 or greater\n17. Massive rotator cuff tears, tear size equal to or greater than 4 cm in the anterior-posterior dimension or irreparable rotator cuff tear\n18. Limited space or exposure for implant delivery\n19. Structural or pathological condition of the bone or soft tissue that could impair healing.\n20. Intraoperative rotator cuff tear characteristics differ from preoperatively expected characteristics and fulfil one of the abovementioned criteria\n21. Fatty infiltration of the index shoulder rotator cuff muscle \\> Goutallier Score 2\n22. Corticosteroid injection in the operative shoulder within 6 weeks of operation\n23. Subject shows frozen shoulder\u002Fadhesive capsulitis at day of surgery\n24. Cases of moderate to severe osteoarthritis\n25. Patients with inflammatory disease or auto-immune based joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, arthropathy)\n26. Subjects with diabetes type I or II\n27. The subject currently has an acute infection in the area surrounding the surgical site\n28. Evidence of active infection, osteomyelitis, sepsis or distant infection which could spread to the index joint.\n29. Any comorbidity or condition that renders the patient a poor surgical candidate as determined by the Investigator.","ALL","40 Years","65 Years",{"count":55,"type":56},50,"ESTIMATED","INTERVENTIONAL",[59],"NA","The overall objective of this clinical investigation is to assess the safety and efficacy of full-thickness arthroscopic rotator cuff repairs augmented with the FiberLocker System for the subjects. The primary outcome of the investigation is to assess the safety after full-thickness arthroscopic rotator cuff repairs augmented with the FiberLocker System in terms of postoperative adverse events through the 12-month follow-up. Main secondary outcomes include measures of efficacy and clinical performance evaluated at 6-week, 4.5-month, and 12-month follow-ups including retear rate assessed using MRI and different functional performance scores.",[62,63,64],"Rotator Cuff Tear","Rotator Cuff Injury","Rotator Cuff Rupture",[66,67,68,69,70],"Rotator cuff tear","Rotator cuff repair","Augmentation","Reinforcement","Mechanical augmentation","2025-07-16",{"date":73,"type":74},"2025-07-17","ACTUAL",{"date":76,"type":74},"2025-07-03",{"date":78,"type":56},"2029-06-30",{"name":5,"class":6},1]