[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"osteoarthritis-of-hip\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:osteoarthritis-of-hip":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100420387","g7-acetabular-system-with-vivacit-e-or-longevity-liner-pmcf-study-100420387",false,"NCT04754087","G7 Acetabular System With Vivacit-E or Longevity Liner PMCF Study","Global, Multicenter, and Prospective Post-Market Clinical Follow-Up Study of the G7 Acetabular System With Vivacit-E and Longevity Highly Crosslinked Polyethylene (HXLPE) Liners & Instrumentation","Inclusion Criteria:\n\n* Patient must be a legal adult who has reached full skeletal maturity.\n* Patient must be treated for one of the following indications:\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 by other techniques\n* Revision procedures where other treatment or devices have failed\n* Patient must be able and willing to complete the protocol required follow-up visits.\n* Patient must be able and willing to sign the Institutional Review Board or Ethics Committee (IRB\u002FEC) approved informed consent.\n\nExclusion Criteria:\n\n* Patient presents with osteoporosis, which in the opinion of the Principal Investigator, may limit the subject's ability to support total hip arthroplasty using the study device.\n* Patient has a metabolic disorder that may impair bone formation.\n* Patient has osteomalacia.\n* Patient has distant foci of infections which may spread to the implant site or patient with infection, sepsis or osteomyelitis.\n* Patient has rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.\n* Patient has a vascular insufficiency, muscular atrophy, or neuromuscular disease\n* Patient is a prisoner.\n* Patient is a current alcohol or drug abuser.\n* Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.\n* Patient is pregnant.",true,"ALL","18 Years",{"count":20,"type":21},300,"ESTIMATED","INTERVENTIONAL",[24],"NA","The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Acetabular Shells when used with the Vivacit-E and Longevity HXLPE liners and instrumentation in primary and revision total hip arthroplasty.",[27,28,29,30,31,32,33,34],"Total Hip Arthroplasty","Degenerative Joint Disease of Hip","Avascular Necrosis of Hip","Rheumatoid Arthritis of Hip","Osteoarthritis, Hip","Osteoarthritis of Hip","Fractures, Hip","Fracture of Hip","RECRUITING","2025-06-13",{"date":38,"type":39},"2025-06-18","ACTUAL",{"date":41,"type":39},"2021-07-07",{"date":43,"type":21},"2033-12-31",{"name":45,"class":46},"Zimmer Biomet","INDUSTRY",11,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100273212","hip-replacement-system-hrs-p-in-primary-total-hip-arthroplasty-100273212","NCT02836262","Hip Replacement System (HRS-P) in Primary Total Hip Arthroplasty","A Multi-Center Prospective Study of the Hip Innovation Technology (HIT) Hip Replacement System in Primary Total Hip Arthroplasty","(HRS-P)","Inclusion Criteria:\n\n* Patient has a non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fracture of the pelvis, and diastrophic variant requiring unilateral primary total hip replacement.\n* Age between 65 and 79 years (inclusive) at the time of enrollment.\n* Patient is a suitable candidate for primary total hip replacement at the discretion of the Investigator.\n* Pre-surgery (within 28 days before surgery) WOMAC Global Score of 40 or larger on a scale from 0 (best) to 96 (worst)\n* Signed and dated informed consent document.\n* Patient is willing and able to participate in required follow-up visits at the Investigational site and to complete study procedures and questionnaires.\n\nExclusion Criteria:\n\n* Patient has had total hip replacement, hemi-arthroplasty, or fusion in either hip in the last 12 months;\n* Patient has planned total hip arthroplasty on a contra-lateral joint in the next 12 months;\n* Patient has a known allergy to any component of the study device;\n* Patient has a history of active sepsis in the joint;\n* Patient has an insufficient acetabular or femoral bone stock in which good anchorage of the implants are unlikely or impossible;\n* Patient has total or partial absence of the muscular or ligamentous apparatus;\n* Patient has known moderate to severe renal insufficiency;\n* Patient has vascular insufficiency, muscular atrophy, or neuromuscular disease in either leg (based on the Investigator's discretion);\n* Patient has a deformity of the affected limb or significant anatomic variance of the affected hip;\n* Patient has an active malignancy or history of invasive malignancy within the last five years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. Patients with carcinoma in situ of the uterine cervix definitively treated more than 1 year prior to enrollment may enter the study;\n* Patient has any condition which may, in the opinion of the Investigator, interfere with the total hip replacement survival or patient outcomes (e.g. Paget's disease, Charcot's disease);\n* Patient has rheumatoid arthritis or other autoimmune condition that affect joints (e.g. Lupus Arthritis);\n* Patient has any condition that would interfere with patient self-assessment or pain, the function or quality of life required for patient reported outcomes during the study (based on the Investigator's discretion);\n* Body Mass Index (BMI) of 40 or more;\n* Patient has an active infection (e.g. hepatitis, AIDS, ARC) - systemic or at the site of intended surgery;\n* Patient is currently participating in any investigational study not related to this study's pre-operative or post-operative care;\n* Patient has any other severe acute or chronic medical condition that may interfere with the interpretation of the study results, in the judgment of the Investigator, which would make the patient inappropriate for entry into this study;\n* Patient has a history of metabolic bone disease (e.g. Paget's disease or osteomalacia);\n* Patient is currently pregnant or is planning to become pregnant.","65 Years","79 Years",{"count":59,"type":21},100,[24],"To evaluate effectiveness and safety of HHRS in subjects undergoing total hip arthroplasty (THA). Effectiveness will be evaluated using patient-reported, clinical, radiologic, and radiostereometric outcomes. Safety will be evaluated through the collection of device-related and unanticipated device-related adverse events.",[32],"2025-03-26",{"date":65,"type":39},"2025-04-01",{"date":67,"type":39},"2017-08-25",{"date":69,"type":21},"2026-08-25",{"name":71,"class":46},"Hip Innovation Technology",1]