[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644325":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":10,"centralContacts":32,"locations":41,"responsibleParty":101,"collaborators":10,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":107,"acronym":10,"eligibilityCriteria":108,"healthyVolunteers":105,"sex":109,"minAge":110,"maxAge":10,"enrollmentInfo":111,"targetDuration":10,"studyType":114,"phases":10,"briefSummary":115,"conditions":116,"keywords":10,"overallStatus":119,"whyStopped":10,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"FX Solutions","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1: Long Cemented HUMELOCK II® Hemi Anatomic Shoulder System for Trauma Indications",null,"Subjects treated with cemented long HUMELOCK II® Hemi Anatomic Shoulder System for traumatic indications",[13],"Procedure: Shoulder arthroplasty",{"label":15,"type":10,"description":16,"interventionNames":17},"Group 2: Long Cemented HUMELOCK II® Hemi Anatomic Shoulder System for Revision Indications","Subjects treated with cemented long HUMELOCK II® Hemi Anatomic Shoulder System for revision indications",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Group 3: Long Cemented HUMELOCK II® Reversible Total Shoulder System for Trauma Indications","Subjects treated with cemented long HUMELOCK II® Reversible Shoulder System for traumatic indications",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Group 4: Long Cemented HUMELOCK II® Reversible Total Shoulder System for Revision Indications","Subjects treated with cemented long HUMELOCK II® Reversible Shoulder System for revision indications",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":10},"PROCEDURE","Shoulder arthroplasty","Hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.",[9,15,19,23],[33,38],{"name":34,"role":35,"phone":36,"phoneExt":10,"email":37},"Kathy TRIER, PhD","CONTACT","800-280-0775","ktrier@fxshouldersolutions.com",{"name":39,"role":35,"phone":40,"phoneExt":10,"email":10},"Gabriel GUEUGNON","+33 6 09 25 38 08",[42,59,73,87],{"facility":43,"status":10,"city":44,"state":10,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"CHU d' Angers","Angers","49933","France","FR",{"type":49,"coordinates":50},"Point",[51,52],-0.55202,47.47156,{"lat":52,"lon":51},[55],{"name":56,"role":35,"phone":57,"phoneExt":10,"email":58},"Romain LANCIGU, MD","+33 6 07 02 11 34","romain.lancigu@gmail.com",{"facility":60,"status":10,"city":61,"state":10,"zip":62,"country":46,"countryCode":47,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Hôpital privé Saint-Martin","Caen","14000",{"type":49,"coordinates":64},[65,66],-0.35912,49.18585,{"lat":66,"lon":65},[69],{"name":70,"role":35,"phone":71,"phoneExt":10,"email":72},"Franck DORDAIN, MD","+33 2 31 06 02 56","fdordain@gmail.com",{"facility":74,"status":10,"city":75,"state":10,"zip":76,"country":46,"countryCode":47,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Clinique Drouot Laffitte","Paris","75009",{"type":49,"coordinates":78},[79,80],2.3488,48.85341,{"lat":80,"lon":79},[83],{"name":84,"role":35,"phone":85,"phoneExt":10,"email":86},"Jules DERANLOT, MD","+33 6 63 55 83 40","dr.deranlot@gmail.com",{"facility":88,"status":10,"city":89,"state":10,"zip":90,"country":46,"countryCode":47,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Hôpital Nord","Saint-Priest-en-Jarez","42277",{"type":49,"coordinates":92},[93,94],4.37678,45.4739,{"lat":94,"lon":93},[97],{"name":98,"role":35,"phone":99,"phoneExt":10,"email":100},"Giorgio GRESTA, MD","+33 6 82 79 82 89","gresta@netcourrier.com",{"type":102,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","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":112,"type":113},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",[117,118],"Humeral Fracture, Proximal","Revision of a Shoulder Prosthesis","NOT_YET_RECRUITING","2026-06-17",{"date":122,"type":123},"2026-06-23","ACTUAL",{"date":125,"type":113},"2026-07",{"date":127,"type":113},"2037-06",{"name":5,"class":6},4]