[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599127":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":16,"locations":22,"responsibleParty":43,"collaborators":10,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":10,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":10,"enrollmentInfo":54,"targetDuration":10,"studyType":57,"phases":10,"briefSummary":58,"conditions":59,"keywords":10,"overallStatus":25,"whyStopped":10,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},{"fullName":5,"class":6},"Zimmer Biomet","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Patients who received the ComposiTCP Suture Anchors Double Loaded with BroadBand Tape, Sliding",null,"No specific interventions will be administered.",[13],{"name":14,"affiliation":5,"role":15},"Emilie Rohmer","STUDY_DIRECTOR",[17],{"name":18,"role":19,"phone":20,"phoneExt":10,"email":21},"Julie NICOUX","CONTACT","+33672613502","julie.nicoux@zimmerbiomet.com",[23],{"facility":24,"status":25,"city":26,"state":10,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"Clinique Mutualiste de Bretagne Occidentale","RECRUITING","Quimper","29000","France","FR",{"type":31,"coordinates":32},"Point",[33,34],-4.09795,47.99597,{"lat":34,"lon":33},[37,41],{"name":38,"role":19,"phone":39,"phoneExt":10,"email":40},"Alexandre Sonnard","+332 57 23 05 05","a.sonnard@orange.fr",{"name":38,"role":42,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"type":44,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100599127","pmcf-study-on-the-safety-performance-and-clinical-benefits-data-of-the-compositcp-100599127",false,"NCT07080450","PMCF Study on the Safety, Performance and Clinical Benefits Data of the ComposiTCP","Post-market Clinical Follow-up Study to Collect Safety, Performance and Clinical Benefits of the ComposiTCP™ Suture Anchors Double Loaded With BroadBand Tape, Sliding","Inclusion Criteria:\n\n* Subject was treated with the ComposiTCP Suture Anchors Double Loaded with BroadBand Tape, Sliding for rotator cuff repair;\n* At least 18 years old and skeletally mature;\n* Willing and able to comply with the study procedures;\n* Subject is capable of understanding the doctor's explanations, following his instructions and is able to participate in the follow-up program;\n* Subject is able to read and understand the ICF and has voluntarily provided written informed consent or non-opposition.\n\nExclusion Criteria:\n\n* Subject is vulnerable (is unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response);\n* The subject is unwilling or unable to give consent or to comply with the follow-up program;\n* Subject meets any contraindications of the appropriate Instruction for Use;\n* Off-Label Use.","ALL","18 Years",{"count":55,"type":56},43,"ESTIMATED","OBSERVATIONAL","The study is a multicenter, retrospective and prospective, non-randomized, noncontrolled, and consecutive series post-market study. The purpose of this study is collect data confirming safety, performance and clinical benefits of the ComposiTCP Suture Anchors Double Loaded with BroadBand Tape, Sliding implants when used in rotator cuff repair.\n\nThe primary endpoint of this study is the assessment of performance by analyzing soft tissue to bone healing in the shoulder (rotator cuff). Healing will be assessed by the investigator using PROMs and clinical outcomes of the patient.\n\nThe clinical benefit will be assessed by functional outcomes measured using standard and well-established scoring systems (e.g. Oxford Shoulder Score and EQ-5D-5L) at 1 year post-operative.\n\nThe safety will be assessed by monitoring the incidence and frequency of device- and\u002For procedure-related adverse events.",[60],"Rotator Cuff Repairs","2026-02-02",{"date":63,"type":64},"2026-02-03","ACTUAL",{"date":66,"type":64},"2025-07-01",{"date":68,"type":56},"2026-08",{"name":5,"class":6},1]