[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05199870":3,"trial-entities:NCT05199870":88,"trial-summary:NCT05199870":98},{"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":24,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":28,"interventions":31,"primary_outcomes":42,"secondary_outcomes":47,"sex":51,"minimum_age":52,"maximum_age":26,"healthy_volunteers":15,"eligibility_criteria":53,"std_ages":68,"locations":71,"central_contacts":81,"overall_officials":82,"references":86,"see_also_links":87},"NCT05199870","MDRG2017-89MS-43H","MDR - PMCF Study for RingLoc Bipolar Acetabular Cup and Endo II Femoral Heads","Post-Market Clinical Follow-Up Study to Provide Safety, Performance and Clinical Benefits Data of the RingLoc Bipolar Acetabular Cup or Endo II Heads (Implants and Instrumentation) in Hip Hemiarthroplasty - A Retrospective Enrollment\u002FProspective Follow-Up Consecutive Series Study","ENROLLING_BY_INVITATION","2027-03","2026-03","2026-03-19","2026-03-10","Zimmer Biomet","INDUSTRY",false,"The objective of this retrospective enrollment\u002Fprospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the RingLoc Bipolar Acetabular Cup and the Endo II Femoral Head when used for hip hemiarthroplasty (implants and instrumentation).","The objective of this retrospective enrollment\u002Fprospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the RingLoc Bipolar Acetabular Cup and the Endo II Femoral Head when used for hip hemiarthroplasty (implants and instrumentation).\n\nThe primary objective of this study is the assessment of safety by analyzing implant survivorship at the longest follow-up timepoint available, greater than or equal to eight years post-implantation. This will be established by recording the incidence and frequency of revisions, complications, and adverse events. Relationship 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 outcomes measures (PROMs).",[19,20,21,22,23],"Hip Arthritis","Hip Disease","Hip Fractures","Hip Injuries","Hip Pain Chronic",[],"OBSERVATIONAL",null,[],{"count":29,"type":30},116,"ESTIMATED",[32,37],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DEVICE","RingLoc Bipolar Acetabular Cup","Patients that have been implanted with a RingLoc Bipolar acetabular cup.",[34],{"type":33,"name":38,"description":39,"armGroupLabels":40},"Endo II Femoral Head","Subjects that have been implanted with an Endo II Femoral Head",[41],"Endo II Femoral Heads",[43],{"measure":44,"description":45,"timeFrame":46},"Device safety assessed through the frequency and incidence of revisions, complications, and Adverse Events.","The primary objective of this study 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 either implant or instrumentation will be specified.","Greater than or equal to 8 years.",[48],{"measure":49,"description":50,"timeFrame":46},"Device Performance and Benefits evaluated through the Oxford Hip Score and Patient Assessment.","The OHS is a patient-completed, 12-question evaluation. Each item is scored from 1 to 5, with 1 representing best outcome\u002Fleast symptoms and 5 representing worst outcome\u002Fmost symptoms. The Patient Assessment is patient completed and a 4-question evaluation.","ALL","18 Years",{"inclusion":54,"exclusion":61,"raw_text":67},[55,56,57,58,59,60],"Patient must be 18 years of age or older and skeletally mature","Patient must have undergone hip hemiarthroplasty surgery with the RingLoc Bipolar Acetabular Cup or Endo II Femoral Head for a cleared indication, greater than or equal to eight years previous to the date of study consent. Cleared indications for the RingLoc Bipolar and Endo II Heads include the following:","Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis","Rheumatoid arthritis","Correction of functional deformity","Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.",[62,63,64,65,66],"Any medical diagnosis present at the time of surgery that, at the Investigator's discretion, could compromise the implant's survivability","Off-label use or not according to the approved instructions for use (IFU) of study devices","Revision procedures where other treatment or devices have failed","Uncooperative patient or patient with neurologic disorders who is incapable of following directions","Patient has a psychiatric illness or","Inclusion Criteria:\n\n* Patient must be 18 years of age or older and skeletally mature\n* Patient must have undergone hip hemiarthroplasty surgery with the RingLoc Bipolar Acetabular Cup or Endo II Femoral Head for a cleared indication, greater than or equal to eight years previous to the date of study consent. Cleared indications for the RingLoc Bipolar and Endo II Heads include the following:\n\n  * Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis\n  * Rheumatoid arthritis\n  * Correction of functional deformity\n  * Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.\n\nExclusion Criteria:\n\n* Any medical diagnosis present at the time of surgery that, at the Investigator's discretion, could compromise the implant's survivability\n* Off-label use or not according to the approved instructions for use (IFU) of study devices\n* Revision procedures where other treatment or devices have failed\n* Uncooperative patient or patient with neurologic disorders who is incapable of following directions\n* Patient has a psychiatric illness or",[69,70],"ADULT","OLDER_ADULT",[72],{"facility":73,"city":74,"state":75,"zip":76,"country":77,"geoPoint":78},"Inova Fairfax Hospital","Falls Church","Virginia","22042","United States",{"lat":79,"lon":80},38.88233,-77.17109,[],[83],{"name":84,"affiliation":13,"role":85},"Lynsey Boyle","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":89,"biomarkers":97},[90,91,92,93,94,95,96],"Avascular Necrosis","Fracture of neck of femur","Functional Deformity","Non-union","Osteoarthritis","Rheumatoid Arthritis","Trochanteric Fractures",[],{"nct_id":4,"found":15,"summary":26,"prompt_version":26}]