[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"revision-of-a-shoulder-prosthesis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:revision-of-a-shoulder-prosthesis":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,38,62],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":26,"lastUpdatePostDateStruct":27,"startDateStruct":30,"completionDateStruct":32,"leadSponsor":34,"locationsCount":37},"100644325","retro-prospective-postmarket-clinical-study-for-fx-shoulder-solutions-long-cemented-humelock-ii-100644325",false,"NCT07663552","Retro-Prospective Postmarket Clinical Study For FX Shoulder Solutions Long Cemented HUMELOCK II®","Inclusion Criteria:\n\n* Indication for hemi anatomic or total reversible shoulder replacement with Long Cemented HUMELOCK II® humeral stem for Trauma or Revision indication, according to its IFU and surgical technique.\n* Patient aged 18 years and above\n* Patient insured with a social security system\n* Has been informed and did consent to participate to the study.\n\nExclusion Criteria:\n\n* Neurological pathologies compromising the shoulder stability\n* Morbid obesity\n* Muscular deficiencies impairing the shoulder joint","ALL","18 Years",{"count":18,"type":19},40,"ESTIMATED","OBSERVATIONAL","This study takes place in the framework of the PostMarket Clinical Follow-up plan of the HUMELOCK II(r) long cemented humeral stem (shoulder prosthesis) commercialized by FX SHOULDER SOLUTIONS.\n\nThe included cases will be followed for 10 years after index surgery. Primary objective is the assessment in real life of the revision rate of the shoulder systems at long-term.\n\nSecondary objectives are\n\n* Revision rate at each post op visit\n* Range of motion at each post op visit\n* Constant Score, American Shoulder and Elbow Surgeons Shoulder Score (ASES), Pain score (VAS) at each post op visit\n* Radiological assessment of implant positioning through geometrical parameters at each post op visit\n* Incidence of complications at each post op visit",[23,24],"Humeral Fracture, Proximal","Revision of a Shoulder Prosthesis","NOT_YET_RECRUITING","2026-06-17",{"date":28,"type":29},"2026-06-23","ACTUAL",{"date":31,"type":19},"2026-07",{"date":33,"type":19},"2037-06",{"name":35,"class":36},"FX Solutions","INDUSTRY",4,{"id":39,"slug":40,"hasResults":11,"nctId":41,"briefTitle":42,"officialTitle":42,"acronym":4,"eligibilityCriteria":43,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":44,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":46,"conditions":47,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":60,"locationsCount":61},"100635892","retro-prospective-postmarket-clinical-study-for-fx-shoulder-solutions-shoulder-systems-100635892","NCT07558590","RETRO-PROSPECTIVE POSTMARKET CLINICAL STUDY FOR FX SHOULDER SOLUTIONS SHOULDER SYSTEMS","Inclusion Criteria:\n\n* Indication for hemi or total shoulder replacement with one of the FX SHOULDER SOLUTIONS Shoulder Systems, according to its IFU and surgical technique.\n* Patient aged 18 years and above\n* Patient insured with a social security system\n* Has been informed and did consent to participate to the study.\n\nExclusion Criteria:\n\n* Neurological pathologies compromising the shoulder stability\n* Morbid obesity\n* Muscular deficiencies impairing the shoulder joint",{"count":45,"type":19},1004,"This study takes place in the framework of the PostMarket Clinical Follow-up plan of the Shoulder Systems commercialized by FX SHOULDER SOLUTIONS.\n\nThe included cases will be followed for 10 years after index surgery. Primary objective is the assessment in real life of the revision rate of the shoulder systems at long-term.\n\nSecondary objectives are\n\n* Revision rate at each post op visit\n* Range of motion at each post op visit\n* Quick Dash, Constant, American Shoulder and Elbow Surgeons Shoulder Score (ASES), Subjective Shoulder Value (SSV), Pain scores at each post op visit\n* Radiological assessment of implant positioning through geometrical parameters at each post op visit\n* Incidence of complications at each post op visit\n* Qualitative feedback from surgeons on the instrumentation",[23,48,49,50,51,52,24],"Glenohumeral Osteoarthritis","Avascular Necrosis of the Head of Humerus","Rotator Cuff Tear","Rotator Cuff Arthropathy","Inflammatory Arthritis","RECRUITING","2026-04-24",{"date":56,"type":29},"2026-04-30",{"date":58,"type":29},"2020-06-01",{"date":33,"type":19},{"name":35,"class":36},22,{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":70,"conditions":71,"keywords":72,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":87},"100466810","pmcf-study-on-the-safety-performance-and-clinical-benefits-data-of-the-anatomical-shoulder-bipolar-system-100466810","NCT05358574","PMCF Study on the Safety, Performance and Clinical Benefits Data of the Anatomical Shoulder Bipolar System","Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Anatomical Shoulderᵀᴹ Bipolar System (Implants and Instrumentation) - A Retrospective and Prospective Consecutive Series Study","Inclusion Criteria:\n\n1. The Anatomical Should Bipolar Adaptor is indicated for hemi shoulder replacement as a salvage solution in situations, where a Zimmer Anatomical Shoulder Inverse\u002FReverse prosthesis was originally planned, but it is intra-operatively found that the attachment of the Zimmer Anatomical Shoulder Inverse\u002FReverse glenoid fixation is not possible\n2. Patient should have received the Anatomical Shoulder Bipolar System\n3. Patient should have signed the Informed Consent Form\n4. Patient is 18-100 years of age, inclusive\n5. Patient is skeletally mature\n\nExclusion Criteria:\n\n1. Patients who are not willing to return for study required follow-up visits and\u002For are not willing to comply with the follow-up schedule\n2. Patients who have any condition which would in the judgement of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, or is a known drug abuser, a known alcoholic or anyone who cannot understand what is required of them\n3. Patient is known to be pregnant or breastfeeding\n4. Musculoskeletal situation that enables the application of a regular hemi or total shoulder system\n5. Good quantity or quality of the glenoid bone, where the fixation of a Zimmer Anatomical Shoulder Inverse\u002FReverse glenoid fixation is possible\n6. Patient's physical conditions that would impair achieving adequate implant support, and\u002For prevent the use of an appropriately sized implant (e.g. due to insufficient quality or quantity of bone).\n7. Signs of infection\n8. Non-functional deltoid muscle\n9. Charcot's shoulder (neuroarthropathy)\n10. Presence of significant injury to the upper brachial plexus\n11. Any neuromuscular or vascular disease compromising the affected limb that would endanger the success of the intervention",{"count":18,"type":19},"The study is a monocentric, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect long-term data confirming safety, performance and clinical benefits of the Anatomical Shoulder Bipolar System (Implants and Instrumentation) when used as a salvage solution in shoulder replacement.\n\nThe primary objective is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications and adverse events. Relation of the events to implant, instrumentation and\u002For procedure should be specified.\n\nThe secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcome measures (PROMs) as well as radiographic outcomes.",[24],[73,74,75,76,77],"Post-Market Clinical Follow-Up Study","Medical Device","Performance","Safety","Clinical Benefits","2025-11-19",{"date":80,"type":29},"2025-11-25",{"date":82,"type":29},"2022-04-22",{"date":84,"type":19},"2033-07-16",{"name":86,"class":36},"Zimmer Biomet",1]