[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100469776":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":19,"locations":29,"responsibleParty":70,"collaborators":10,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":10,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":10,"enrollmentInfo":81,"targetDuration":10,"studyType":84,"phases":10,"briefSummary":85,"conditions":86,"keywords":10,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Xiros Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Infinity-Lock™ Button System",null,"Participants diagnosed with acute or chronic Grade Ill-VI ACJ dislocation who require treatment with an Infinity-Lock Button System who meet the inclusion criteria and none of the exclusion criteria.",[13],"Device: Infinity-Lock Button System",[15],{"type":16,"name":17,"description":17,"armGroupLabels":18,"otherNames":10},"DEVICE","Infinity-Lock Button System",[9],[20,25],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"Lisa Cook","CONTACT","+44 (0) 113 238 7200","lisa.cook@xiros.co.uk",{"name":26,"role":22,"phone":27,"phoneExt":10,"email":28},"Vikki Adams","07825626018","vikki.adams@xiros.co.uk",[30,42,51,60],{"facility":31,"status":32,"city":33,"state":10,"zip":10,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":10},"East Kent Hospitals University NHS Foundation Trust,","RECRUITING","Canterbury","United Kingdom","UK",{"type":37,"coordinates":38},"Point",[39,40],1.07992,51.27904,{"lat":40,"lon":39},{"facility":43,"status":32,"city":44,"state":10,"zip":45,"country":34,"countryCode":35,"cosmosGeoPoint":46,"geoPoint":50,"contacts":10},"Barts Health NHS Trust","London","E1 1FR",{"type":37,"coordinates":47},[48,49],-0.12574,51.50853,{"lat":49,"lon":48},{"facility":52,"status":32,"city":53,"state":10,"zip":54,"country":34,"countryCode":35,"cosmosGeoPoint":55,"geoPoint":59,"contacts":10},"Nottingham University Hospitals","Nottingham","NG7 2UH",{"type":37,"coordinates":56},[57,58],-1.15047,52.9536,{"lat":58,"lon":57},{"facility":61,"status":62,"city":63,"state":10,"zip":64,"country":34,"countryCode":35,"cosmosGeoPoint":65,"geoPoint":69,"contacts":10},"Royal Berkshire NHS Foundation Trust","ACTIVE_NOT_RECRUITING","Reading","RG1 5AN",{"type":37,"coordinates":66},[67,68],-0.97113,51.45625,{"lat":68,"lon":67},{"type":71,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100469776","post-market-clinical-follow-up-pmcf-study-of-the-infinity-lock-button-system-for-acromioclavicular-joint-stabilisation-100469776",false,"NCT05397210","Post-market Clinical Follow-up (PMCF) Study of the Infinity-Lock Button System for Acromioclavicular Joint Stabilisation","Post-market Clinical Follow-up (PMCF) Study of the Infinity-Lock™ Button System for Acromioclavicular Joint Stabilisation","Inclusion Criteria:\n\n* Patient must be 16 years old or above.\n\n  * Patient is diagnosed with acute or chronic Grade Ill-VI ACJ dislocation.\n  * Patient is willing to participate in the study and have been informed of the nature of the study, agree to its follow-up and have provided written informed consent as approved by the Research Ethics Committee (REC).\n\nExclusion criteria.\n\n* Known hypersensitivity to implant materials. If the patient is suspected of having any foreign body sensitivity, appropriate tests should be made prior to implantation.\n* Infections or any other structural or pathological condition of the bone or soft tissue (such as hyperlaxity) that would be expected to impair healing or secure fixation.\n* Patients unable or unwilling to restrict activities to prescribed levels or follow a rehabilitation programme during the healing period.\n* Skeletally immature patients are not suited as the Infinity-Lock™ Button System will not elongate with growth. The use of this medical device and placement of hardware or implants must not bridge, disturb or disrupt the growth plate.\n* Any other conditions or factors which in the opinion of the Investigator may interfere with study conduct.","ALL","16 Years",{"count":82,"type":83},58,"ESTIMATED","OBSERVATIONAL","This is a Post-market Clinical Follow-up Study. It will verify the long-term safety and performance of the Infinity-Lock Button System (ILBS) when used for acute and chronic dislocations of the Acromioclavicular Joint and used as described by the manufacturer's instructions.",[87],"Acromioclavicular; Dislocation","2026-01-26",{"date":90,"type":91},"2026-01-27","ACTUAL",{"date":93,"type":91},"2022-09-26",{"date":95,"type":83},"2030-01",{"name":5,"class":6},4]