[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100504563":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":10,"centralContacts":28,"locations":38,"responsibleParty":61,"collaborators":10,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":10,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":10,"enrollmentInfo":72,"targetDuration":10,"studyType":75,"phases":10,"briefSummary":76,"conditions":77,"keywords":10,"overallStatus":41,"whyStopped":10,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Exactech","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Prospective Subjects",null,"Enrolled in the study pre-surgery. Subjects who agree to participate in the study that have not had surgery prior to being enrolled in the study.",[13],"Device: Exactech Hip Systems",{"label":15,"type":10,"description":16,"interventionNames":17},"Retrospective to Prospective","Subjects enrolled in the study post- surgery then continue to participate in the study prospectively. Subjects who agree to participate in the study that have undergone surgery prior to enrollment in the study. Data for these subjects will collected from the subject's medical record for the time period prior to enrollment in the study containing data pertaining to the index surgery (retrospective data) and from the patient after they are enrolled in the study during the post-operative time period (prospectively).",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Retrospective Only Subjects","Subjects enrolled in the study post-study surgery with no intent to continue as prospective subjects. Patient's clinical record includes a signed HIPAA waiver allowing for the use of clinical record data for the purpose of clinical research outside of the operating institution.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"DEVICE","Exactech Hip Systems","The Exactech Hip System comprises a fixed-bearing hip joint prostheses used in treating human hip joint diseases as part of THA. These prostheses include a combination of the components and are available in a range of sizes to accommodate varying anatomical requirements.",[9,19,15],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Pearl Harris","CONTACT","352-377-1140","pearl.harris@exac.com",{"name":35,"role":31,"phone":36,"phoneExt":10,"email":37},"Alex Knisely","352-474-9582","alex.knisely@exac.com",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Tulsa Bone & Joint Associates","RECRUITING","Tulsa","Oklahoma","74146","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-95.99277,36.15398,{"lat":51,"lon":50},[54,58],{"name":55,"role":31,"phone":56,"phoneExt":10,"email":57},"Faye Biggs","918-392-1400","f.biggs@tbja.org",{"name":59,"role":60,"phone":10,"phoneExt":10,"email":10},"Scott Dunitz, MD","PRINCIPAL_INVESTIGATOR",{"type":62,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100504563","exactech-hip-systems-post-market-clinical-follow-up-pmcf-100504563",false,"NCT05849961","Exactech Hip Systems Post-Market Clinical Follow-up (PMCF)","TM-2023-017318 Exactech Hip Systems PMCF: A Post-Market Domestic (US) and International Data Collection to Assess Exactech Hip Systems","Inclusion Criteria:\n\nCohort 1:\n\n* Subjects who agree to participate in the study that have not had surgery prior to being enrolled in the study.\n* Skeletally mature (18 years of age or older).\n* The subject is willing and able to provide written informed consent for participation in the study.\n* Subject is to receive an Exactech Hip System THA for any approved indication for use.\n* The hip replacement will be performed by the investigator or a surgeon sub- investigator.\n* The devices will be used according to the approved indications.\n\nCohort 2:\n\n* Subjects who agree to participate in the study that have undergone surgery prior to enrollment in the study. Data for these subjects will be collected from the subject's medical record for the time-period prior to enrollment in the study containing data pertaining to the preoperative time period and index surgery (retrospective data) and from the patient after they are enrolled in the study during the post-operative time- period (prospectively).\n* Skeletally mature (18 years of age or older).\n* The subject is willing and able to provide written informed consent for participation in the study.\n* Subject received an Exactech Hip System THA for any approved indication for use.\n* The hip replacement was performed by the investigator or a surgeon sub-investigator.\n* The devices are\u002Fwere used according to the approved indications.\n* Special consideration should be taken to ensure that these subjects meet all inclusion criteria, none of the exclusion criteria, and have a minimum of the following pre- operative, operative, and applicable postoperative data available in the subject's medical records, related to the Exactech Hip System prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA). Prior to inclusion in the study, the following details must be available for data submission:\n\nPre-Operative:\n\nDemographic Data\n\n* Gender\n* Age at surgery\n* Height\u002FWeight\n* Indication for surgery\n* Prior Injuries\u002FSurgeries on index hip\n* Comorbidities\n\nOperative:\n\n* Date of Surgery\n* Type of Surgery (Primary \u002F Revision)\n* All component product information, including catalogue reference numbers.\n* Adverse Event Information, if applicable\n\nCohort 3:\n\nNote: No prospective data may be collected from a subject if they are enrolled under this cohort unless the subject is willing and able to provide written informed consent for participation in the study, in which case they should be part of Cohort 2.\n\n* Skeletally mature (18 years of age or older).\n* The subject is willing and able to provide written informed consent for participation in the study.\n* Subject received an Exactech Hip System THA for any approved indication for use.\n* The hip replacement was performed by the investigator or a surgeon sub-investigator.\n* The devices are\u002Fwere used according to the approved indications.\n* Special consideration should be taken to ensure that these subjects meet all inclusion criteria, none of the exclusion criteria, and have a minimum of the following pre- operative, operative, and applicable postoperative data available in the subject's medical records, related to the Exactech Hip System prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA). Prior to inclusion in the study, the following details must be available for data submission:\n\nPre-Operative:\n\nDemographic Data\n\n* Gender\n* Age at surgery\n* Height\u002FWeight\n* Indication for surgery\n* Prior Injuries\u002FSurgeries on index hip\n* Comorbidities\n\nOperative:\n\n* Date of Surgery\n* Type of Surgery (Primary \u002F Revision)\n* All component product information, including catalogue reference numbers.\n* Adverse Event Information, if applicable\n\nExclusion Criteria:\n\n* Patient was \\\u003C18 years of age at time of surgery\n* Patient does not meet the indicated population for use criteria for this device.\n* Patient is pregnant\n* Patient is a prisoner\n* Patient has a physical or mental condition that would invalidate the results\n* Patient is contraindicated for the surgery (e.g., metal allergy)","ALL","18 Years",{"count":73,"type":74},2946,"ESTIMATED","OBSERVATIONAL","A Post-Market Domestic (US) and International Data Collection to Assess Exactech Hip Systems",[78],"Hip Arthroplasty, Total","2024-06-17",{"date":81,"type":82},"2024-06-18","ACTUAL",{"date":84,"type":82},"2023-10-13",{"date":86,"type":74},"2036-12-31",{"name":5,"class":6},1]