[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"DePuy Orthopaedics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100564627","emphasys-cup-positioning-in-tha-with-non-invasive-navigation-velys-hip-navigation-vhn-100564627",false,"NCT06631638","EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))","Planned vs. Actual Acetabular Cup Position in Total Hip Arthroplasty With Non-Invasive Navigation","Inclusion Criteria:\n\n1. All hip replacement component devices are to be used according to the approved indications.\n2. The subject is undergoing a standard of care primary uncemented hip replacement with the EMPHASYS cup and a CORAIL, EMPHASYS or ACTIS stem via the posterolateral, anterolateral, or direct lateral approach with the subject in the lateral decubitus position.\n3. The subject is a candidate for implantation utilizing the VELYS Hip Navigation system with CUPTIMIZE advanced\n4. Individuals who are able to speak, read, and comprehend the Informed Participant Consent Document and willing and able to provide consent for participation in the study and have authorized the transfer of his\u002Fher information to DePuy Synthes.\n5. Individuals who are willing and able to complete follow-up as specified by the study protocol.\n6. Individuals who are willing and able to complete the Subject Hip Outcomes questionnaires (i.e., FJS-12, EQ-5D-5L and Hip Evaluation) as specified by the study protocol.\n7. Individuals who are not bedridden per the discretion of the investigator.\n8. Individuals who are a minimum age of 21 years at the time of consent\n\nExclusion Criteria:\n\n1. Active local or systemic infection.\n2. Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.\n3. Poor bone quality, such as osteoporosis, where, in the surgeon's opinion, there could be considerable migration of the prosthesis or a significant chance of fracture of the femoral shaft and\u002For the lack of adequate bone to support the implant(s).\n4. Charcot's or Paget's disease.\n5. The Subject is a woman who is pregnant or lactating.\n6. Subject had a contralateral amputation.\n7. Previous partial hip replacement in affected hip.\n8. Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three months.\n9. Contralateral hip was replaced less than 6 months prior to surgery date.\n10. Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.\n11. Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.\n12. Subject has a medical condition with less than 2 years of life expectancy.\n13. Subject, in the opinion of the Investigator, is a drug or alcohol abuser or has a psychological disorder that could affect their ability to complete subject reported questionnaires or be compliant with follow-up requirements.","ALL","21 Years",{"count":19,"type":20},118,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of this research is to gather clinical and radiographic (X-ray) information about EMPHASYS™ acetabular shell (also called a hip 'cup') placement in total hip replacement surgery using a non-invasive surgical navigation system called VELYS™ hip navigation system with CUPTIMIZE™ Advanced Hip-Spine Analysis software.\n\nData collected in this study will be compared with data collected from implantations using different cup positioning instrumentation and techniques to assess performance.",[26,27,28,29,30,31],"Osteoarthritis","Traumatic Arthritis","Rheumatoid Arthritis","Congential Hip Dysplasia","Avascular Necrosis of the Femoral Head","Certain Cases of Ankylosis","RECRUITING","2026-06-04",{"date":35,"type":36},"2026-06-05","ACTUAL",{"date":38,"type":36},"2025-10-24",{"date":40,"type":20},"2027-12-31",{"name":42,"class":43},"DePuy Orthopaedics","INDUSTRY",5,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100540986","inhance-stemless-reverse-shoulder-ide-100540986","NCT06323980","INHANCE Stemless Reverse Shoulder IDE","Randomized, Prospective, Multi-Center Study of the INHANCE Stemless Total Reverse Shoulder System","Inclusion Criteria:\n\n1. Individuals requiring reverse total shoulder replacement for a severely painful, disabling, arthritic joint (i.e. osteoarthritis, post-traumatic arthritis and rotator cuff arthropathy).\n2. Individuals who are anatomically and structurally suited to receive the implants and have a functional deltoid muscle.\n3. Individuals who are able to read and comprehend the informed patient consent document and are willing and able to provide informed patient consent for participation in the study and have authorized the transfer of their information to DePuy Synthes.\n4. Individuals who are willing and able to return for follow-up as specified by the study protocol.\n5. Individuals who are a minimum age of 22 years at the time of consent.\n6. Individuals who are willing and able to complete the Patient Reported Outcome Measure questionnaires (PROMs) as specified by the study protocol.\n\nExclusion Criteria:\n\n1. BMI \\> 40 kg\u002Fm2\n2. Individuals have active, uncontrolled local infection or systemic infection.\n3. Patients who have not reached skeletal maturity, regardless of age.\n4. Either preoperatively or intraoperatively and per standard of care medical assessment, bone stock in the proximal humerus or glenoid fossa is determined to be inadequate for supporting the INHANCE humeral stemless components (NOTE: exclusion applies to both arms of the study, i.e., bone stock to be evaluated independent of randomized treatment assignment).\n5. Intraoperatively and per treating physician's assessment of bone quality, bone is determined to be too soft or porous to support the implant or that is too hard or brittle to allow for proper bone preparation and fixation, i.e. osteoporosis or sclerotic bone, or tumor(s) of the supporting bone structure, where there could be considerable migration of the prosthesis and\u002For a chance of fracture of the humerus or glenoid.\n6. Fractures of the proximal humerus that could compromise the fixation of the INHANCE reverse humeral stemless components.\n7. Patients who have undergone previous treatment on the study shoulder that may compromise fixation of the INHANCE reverse humeral stemless component.\n8. Revision of a failed hemi, total or reverse shoulder arthroplasty.\n9. Patient is receiving, or is scheduled to receive, treatment that the Investigator considers could affect bone quality, such as chemotherapy or high dose corticosteroids.\n10. Individuals who are bedridden per the Investigator's determination.\n11. Individuals that have participated in a clinical investigation with an investigational product (drug or device) in the last three months.\n12. Individuals currently involved in any personal injury litigation, medical-legal or worker's compensation claims.\n13. Individuals, in the opinion of the Investigator, who are drug or alcohol abusers or have psychological disorders that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements.\n14. Patients with a known medical condition that the Investigator believes would impact the study outcomes (including, but not limited to osteomyelitis, Paget's disease, neuropathies such as Charcot's disease, metastatic or neoplastic disorders).\n15. Patient has a medical condition with less than 2 years life expectancy.\n16. Patients who are known to be pregnant or breastfeeding.\n17. Known polyethylene and\u002For metal sensitivity or allergy.\n18. Contralateral side has been enrolled in the study or has received a total shoulder operation within the last 6 months\n19. Otherwise determined by the investigator to be medically unsuitable for participation in this study\n20. Patient is a member of a vulnerable population (i.e., incarcerated individuals - those incarcerated for at least one month and considered to be an inmate)","22 Years",{"count":54,"type":20},168,[23],"2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder.",[58,59,60],"Arthroplasty","Replacement","Shoulder",[62,63,64],"Reverse Shoulder","Stemless Shoulder","Total Shoulder",{"date":35,"type":36},{"date":67,"type":36},"2025-03-04",{"date":69,"type":20},"2028-10-30",{"name":42,"class":43},19,""]