[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hip Innovation Technology\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100466718","safety-and-effectiveness-of-the-hit-reverse-hrs-100466718",false,"NCT05357378","Safety and Effectiveness of the HIT Reverse HRS","Safety and Effectiveness of the Hip Innovation Technology Reverse Hip Replacement System in Primary Total Hip Arthroplasty: A Pivotal Study","Inclusion Criteria:\n\n* Patient requires primary THA due to NIDJD or any of its composite diagnoses such as osteoarthritis, avascular necrosis, posttraumatic arthritis, slipped capital epiphysis, fracture of the pelvis, and diastrophic variant requiring unilateral primary THA.\n* Patient is between 50 (inclusive) and 75 (inclusive) years of age at the time of enrollment.\n* Patient has preoperative medical clearance and is free from or treated for medical conditions that would pose excessive operative risk.\n* Patient has a signed and dated Informed Consent Form (ICF).\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 received earlier THA, hemi-arthroplasty, or fusion in the contralateral hip in the last 24 months.\n* Patient has received earlier THA, hemi-arthroplasty, or fusion in the contralateral hip more than 24 months ago and has a contralateral hip-specific pain rating of ≥2 on a Numeric Rating Scale 0-10.\n* Patient needs bilateral hip replacement or has a planned THA on the contralateral hip joint in the next 24 months.\n* Patient needs knee arthroplasty or has a planned total knee arthroplasty in the next 24 months.\n* Patient has a known allergy to titanium and\u002For XLPE.\n* Patient has known metal sensitivities to cobalt chromium (CoCr).\n* Patient has a history of septic arthritis in the index joint.\n* Patient has insufficient acetabular or femoral bone stock in which good anchorage of the implants is 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 judgment).\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 5 years, except for 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 Paget's disease, Charcot-Marie-Tooth disease, or osteomalacia.\n* Patient has an inflammatory DJD including any of its composite diagnoses: rheumatoid arthritis, systemic lupus erythematosus, pigmented villonodular synovitis, juvenile rheumatoid arthritis, and other arthritic processes of inflammatory or autoimmune etiology.\n* Patient has any condition that would interfere with self-assessment of pain, function, or quality of life (QoL) required for patient-reported outcomes during the study (based on the Investigator's judgment).\n* Patient has a Body Mass Index (BMI) of 40 or higher.\n* Patient has an active infection (e.g., hepatitis, Acquired Immune Deficiency Syndrome (AIDS), AIDS-related Complex (ARC)) that is systemic or at the site of the intended surgery.\n* Patient is currently participating in any investigational study not related to this study's preoperative or postoperative care.\n* Patient is currently pregnant or is planning to become pregnant during the study.\n* Patient is a competitive or professional athlete.","ALL","50 Years","75 Years",{"count":20,"type":21},288,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this study is to determine if the use of the HIT Reverse Hip Replacement System is safe and effective in patients undergoing total hip replacement. We will determine whether it is safe and effective by comparing it to the control devices.",[27,28,29,30],"Degenerative Joint Disease","Osteoarthritis, Hip","Avascular Necrosis of Hip","Traumatic Arthropathy-Hip",[32],"total hip arthroplasty","RECRUITING","2026-05-07",{"date":36,"type":37},"2026-05-11","ACTUAL",{"date":39,"type":37},"2022-07-15",{"date":41,"type":21},"2035-07-15",{"name":43,"class":44},"Hip Innovation Technology","INDUSTRY",6,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"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":57,"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.",[61],"Osteoarthritis of Hip","2025-03-26",{"date":64,"type":37},"2025-04-01",{"date":66,"type":37},"2017-08-25",{"date":68,"type":21},"2026-08-25",{"name":43,"class":44},1,""]