[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05583448":3,"trial-entities:NCT05583448":91,"trial-summary:NCT05583448":94},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":15,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":32,"secondary_outcomes":40,"sex":45,"minimum_age":46,"maximum_age":15,"healthy_volunteers":47,"eligibility_criteria":48,"std_ages":69,"locations":72,"central_contacts":87,"overall_officials":88,"references":89,"see_also_links":90},"NCT05583448","MDRG2017-89MS-77E","MDR ExploR Radial Head System PMCF","Post-market Clinical Follow-up Study of the ExploR™ Radial Head System (Implants and Instrumentation) - A Retrospective Enrollment\u002FProspective Follow-Up Consecutive Series Study","ENROLLING_BY_INVITATION","2035-07-19","2026-02","2026-02-04","2022-08-16","Zimmer Biomet","INDUSTRY",null,"The objective of this retrospective and prospective consecutive series PMCF study is to collect long-term data confirming safety, performance and clinical benefits of the ExploR Radial Head System (implants and instrumentation) when used for radial head arthroplasty.","This is a global, multi-center, retrospective enrollment, prospective follow-up, consecutive series post-market clinical follow-up study. The intent of the study is that subjects who have already had the surgical implant will be retrospectively enrolled in the study and data will be collected for a minimum of 10 years post-operatively. Subjects treated with the device will be identified and invited to participate in the study. 93 subjects will be enrolled into the study.",[19],"Elbow Injury",[],"OBSERVATIONAL",[],{"count":24,"type":25},93,"ESTIMATED",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31},"DEVICE","ExploR Radial Head","Patient must have undergone primary elbow arthroplasty with the ExploR Radial Head System according to a cleared indication.",[29],[33,37],{"measure":34,"description":35,"timeFrame":36},"Device Survivorship","Measured by recording and analyzing the incidence and frequency of revisions, complications and adverse events. Survivorship is calculated with Kaplan Meier.","10 years",{"measure":38,"description":39,"timeFrame":36},"Device Safety","Assessed by recording frequency of adverse events during the length of the study.",[41],{"measure":42,"description":43,"timeFrame":44},"QuickDASH","QuickDASH measures musculoskeletal pain and function of the arm. Higher scores indicate higher severity of disability.","1, 3, 5, 7, and 10 years","ALL","18 Years",false,{"inclusion":49,"exclusion":53,"raw_text":68},[50,51,52],"Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radio-humeral and\u002For proximal radio-ulnar joint with:","Primary replacement after fracture of the radial head","Symptomatic sequelae after radial head resection Patient must be 18 years of age or older. Patient must be willing and able to follow directions.",[54,55,56,57,58,59,60,61,62,63,64,65,66,67],"Infection","Sepsis","Osteomyelitis","Uncooperative patient or patient with neurological disorders who are incapable of following directions","Osteoporosis","Metabolic disorders which may impair bone formation","Osteomalacia","Distant foci of infections which may spread to implant site","Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram","Patient is a prisoner.","Patient is a current alcohol or drug abuser.","Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent","Patient is known to be pregnant or breastfeeding.","Patient is unwilling to sign informed consent.","Inclusion Criteria:\n\nPatient must have undergone primary elbow arthroplasty with the ExploR Radial Head System according to a cleared indication, which includes the following:\n\n* Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radio-humeral and\u002For proximal radio-ulnar joint with:\n\nJoint destruction and\u002For subluxation visible on x-ray Resistance to conservative treatment\n\n* Primary replacement after fracture of the radial head\n* Symptomatic sequelae after radial head resection Patient must be 18 years of age or older. Patient must be willing and able to follow directions.\n\nExclusion Criteria:\n\n* Infection\n* Sepsis\n* Osteomyelitis\n* Uncooperative patient or patient with neurological disorders who are incapable of following directions\n* Osteoporosis\n* Metabolic disorders which may impair bone formation\n* Osteomalacia\n* Distant foci of infections which may spread to implant site\n* Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram\n* Patient is a prisoner.\n* Patient is a current alcohol or drug abuser.\n* Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent\n* Patient is known to be pregnant or breastfeeding.\n* Patient is unwilling to sign informed consent.",[70,71],"ADULT","OLDER_ADULT",[73,82],{"facility":74,"city":75,"state":76,"zip":77,"country":78,"geoPoint":79},"Norton Healthcare","Louisville","Kentucky","40241","United States",{"lat":80,"lon":81},38.25424,-85.75941,{"facility":83,"city":84,"zip":85,"country":86},"Akershus University Hospital","Lørenskog","1478","Norway",[],[],[],[],{"nct_id":4,"conditions":92,"biomarkers":93},[19],[],{"nct_id":4,"found":47,"summary":15,"prompt_version":15}]