[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acromioclavicular-dislocation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acromioclavicular-dislocation":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":26,"lastUpdatePostDateStruct":27,"startDateStruct":30,"completionDateStruct":32,"leadSponsor":34,"locationsCount":37},"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":19,"type":20},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.",[24],"Acromioclavicular; Dislocation","RECRUITING","2026-01-26",{"date":28,"type":29},"2026-01-27","ACTUAL",{"date":31,"type":29},"2022-09-26",{"date":33,"type":20},"2030-01",{"name":35,"class":36},"Xiros Ltd","INDUSTRY",4]