[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600180":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":16,"locations":26,"responsibleParty":45,"collaborators":10,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":10,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":54,"minAge":55,"maxAge":10,"enrollmentInfo":56,"targetDuration":10,"studyType":59,"phases":10,"briefSummary":60,"conditions":61,"keywords":66,"overallStatus":70,"whyStopped":10,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"JointMedica Inc.","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Patient Group",null,"The patient group is the entire group of patients who have been implanted with the JointMedica Custom-Made Hip Resurfacing system. This is the only group in the study, all patients will be assessed under the same criteria.",[13],{"name":14,"affiliation":10,"role":15},"Ronan Treacy","PRINCIPAL_INVESTIGATOR",[17,22],{"name":18,"role":19,"phone":20,"phoneExt":10,"email":21},"Steve Meakins","CONTACT","+441905978264","steve@jointmedica.com",{"name":23,"role":19,"phone":24,"phoneExt":10,"email":25},"Oyin Akintomide","+441905640008","oyin@jointmedica.com",[27],{"facility":28,"status":10,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"RBC Treacy Practice","Worcester","Bromsgrove","B60 4HJ","United Kingdom","UK",{"type":35,"coordinates":36},"Point",[37,38],-2.22001,52.18935,{"lat":38,"lon":37},[41],{"name":42,"role":19,"phone":43,"phoneExt":10,"email":44},"Wendy Richards","+44121 454 6161","Treacyhip@aol.com",{"type":46,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100600180","clinical-and-radiographic-outcomes-of-the-jointmedica-custom-made-resurfacing-device-100600180",false,"NCT07094139","Clinical and Radiographic Outcomes of the JointMedica Custom-Made Resurfacing Device","Inclusion Criteria:\n\n* Age 21 or above at the time of the surgery.\n* Have had the JointMedica Custom-Made Hip Resurfacing device implanted between September 2020 to January 2025\n* Written informed consent given by subject\n\nExclusion Criteria:\n\n* There is no exclusion criteria for this study",true,"ALL","21 Years",{"count":57,"type":58},41,"ESTIMATED","OBSERVATIONAL","The Custom Resurfacing (CR) Implants are indicated for use for the reduction or relief of pain and\u002For improved hip function all skeletally mature patients where a total joint replacement is indicated, and where there is no other suitable, commercially distributed device available.\n\nThe Resurfacing System is a metal-on-polyethylene hip resurfacing device consisting of a metallic femoral component and an acetabular component made of Vitamin E HXLPE with a titanium coating on its bone-contacting surface.\n\nThe custom-Made Hip Resurfacing System is a single use device intended for hybrid fixation: cemented femoral head component and cementless acetabular component.\n\nThe goal of this observational study is to generate Real World Evidence (RWE) on the device performance of the Polymotion Hip Resurfacing (PHR) system and its use in patients who have been implanted with the device for the treatment of hip osteoarthritis.\n\nThis study will assess the following endpoints:\n\n* The survivorship of the Acetabular Cup (Kaplan-Meier estimate) through 2 years of follow-up.\n* Radiographic success of the implanted cups, through quantitative motion analysis to assess migration of the acetabular cups.\n* Absence of subsequent surgical intervention at the acetabulum of there operated hip.\n* Absence of serious, device-related adverse events.\n* Patient reported outcomes through Harris Hip Score and SUSHI - UCLA Hip Score questionnaires.",[62,63,64,65],"Healthy","Real World Data","Safety and Effectiveness","Patient Reported Outcome (PRO)",[67,68,69],"Custom-Made Hip Resurfacing","Hip Resurfacing","Hip Arthroplasty","NOT_YET_RECRUITING","2025-07-23",{"date":73,"type":74},"2025-07-30","ACTUAL",{"date":76,"type":58},"2025-08",{"date":78,"type":58},"2026-12",{"name":5,"class":6},1]