[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Exactech\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":188},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,46,68,85,105,127,148,167],{"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":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100485642","exactech-shoulder-post-market-clinical-follow-up-study-100485642",false,"NCT05603728","Exactech Shoulder Post Market Clinical Follow-up Study","An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Shoulder Arthroplasty Clinical and Radiographic Outcomes","Inclusion Criteria:\n\n* Patient is indicated for shoulder arthroplasty (or has previously undergone shoulder arthroplasty)\n* Patient is skeletelly mature\n* Patient is expected to survive at least 2 years beyond surgery\n* Patient is willing to participate by complying with pre- and postoperative visit requirements\n* Patient is willing and able to read and sign a study informed consent form\n\nExclusion Criteria:\n\n* Osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, implantation should be delayed until infection is resolved\n* Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis\n* Medial humeral bone loss resulting in compromised humeral stem fixation\n* Proximal humeral bone loss extending distal to the surgical neck where there is compromised humeral stem fixation\n* Neuromuscular disorders that do not allow control of the joint\n* Significant injury to the brachial plexus\n* Non-functional deltoid muscles\n* Patient's age, weight, or activity level would cause the surgeon to expect early failure of the system\n* The patient is unwilling or unable to comply with the post-operative care instructions\n* Alcohol, drug, or other subtance abuse\n* Any disease state that could adversaly affect the function or longevity of the implant\n* Patient is pregnant\n* Patient is a prisoner\n* Patient is contraindicated for the surgery\n* Revision cases in which a stemmed humeral component was used (Stemless Shoulder System)\n* Metal allergy or sensitivity to the implants materials (Stemless Shoulder System)\n* Acute fracture of the proximal humerus and displacement of the tuberosities, displaced three or four part fractures of the proximal humerus (hemi-arthroplasty), or acture fracture of the proximal humerus with failure of the glenohumeral joint (total anatomic shoulder arthroplasty) (Stemless Shoulder System)\n* Acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty) (Stemless Shoulder System)","ALL","21 Years",{"count":19,"type":20},20000,"ESTIMATED","OBSERVATIONAL","The objective of this study is to collect and evaluate long-term clinical and radiographic outcomes data in order to better understand the safety and performance of the shoulder arthroplasty over time. This study will follow subjects long-term for a minimum of 10-years, without an early-term restriction on the amount of time they will be followed.",[24,25,26,27,28,29,30,31,32],"Osteo Arthritis Shoulders","Osteonecrosis","Rotator Cuff Tears","Rotator Cuff Tear Arthropathy","Ankylosing Spondylitis","Post-traumatic Osteoarthritis","Rheumatoid Arthritis","Fracture","Infections","RECRUITING","2025-12-09",{"date":36,"type":37},"2025-12-15","ACTUAL",{"date":39,"type":37},"2007-07-19",{"date":41,"type":20},"2031-12-31",{"name":43,"class":44},"Exactech","INDUSTRY",38,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100492417","vantage-mobile-bearing-total-ankle-system-post-market-clinical-follow-up-outside-us-100492417","NCT05691868","Vantage Mobile Bearing Total Ankle System Post Market Clinical Follow-up (Outside US)","An Open Label, Multi-Center, Single Arm Prospective Evaluation of Exactech Vantage Total Ankle System (Outside US)","Inclusion Criteria:\n\n* Patient is indicated for total ankle arthroplasty\n* Patient is at least 21 years of age\n* Patient is likely to be available for follow-up out to 10 years\n* Patient is willing to participate by complying with pre- and postoperative visit requirements\n* Patient is willing and able to read and sign a study informed consent form\n\nExclusion Criteria:\n\n* Patient with excessive bone loss at the ankle joint site\n* Patient with severe osteoporosis\n* Patient with complete talar avascular necrosis\n* Patient with active osteomyelitis\n* Patient with infection at the ankle site or infection at distant sites that could migrate to the ankle\n* Patient with sepsis\n* Patient with vascular deficiency in the involved limb\n* Pateint with neuropathic joints\n* Patient with neurological or musculoskeletal disease or loss of function that may adversely affect movement of the lower limb, gait, or weight bearing\n* Patient with poor soft tissue coverage around the ankle\n* Patient with Charcot arthropathy\n* Previsous ankle arthrodesis with excision of the malleoli\n* Excessive loads as cuased by activity or patient weight - per investigator discretion\n* Skeletally immature patients (patient is less than 21 years if age at time of surgery)\n* Patient with dementia\n* Patient with known metal allergies\n* Patients who are unwilling to provide informed consent\n* Patients who are unlikely to be available for follow-up out to 10 years\n* Patients who are not deemed suitable candidates for the subject device\n* Patient is pregnant",{"count":54,"type":20},400,"The objectives of this study are to evaluate the performance and safety of the Vantage Mobile-Bearing Total Angle System. This study will follow subjects for a period of up to 10 years post-surgery.",[30,57,58],"Arthritis of Ankle","Failure, Prosthesis","2025-02-26",{"date":61,"type":37},"2025-02-27",{"date":63,"type":37},"2019-04-08",{"date":65,"type":20},"2031-09-30",{"name":43,"class":44},2,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":80,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":84,"locationsCount":67},"100486862","exactech-vantage-total-ankle-system-post-market-clinical-follow-up---us-only-100486862","NCT05619588","Exactech Vantage Total Ankle System Post Market Clinical Follow-Up - US Only","An Open Label, Multi-Center, Single Arm Prospective Evaluation of Exactech Vantage Total Ankle System","Inclusion Criteria:\n\n* Patient is indicated for total ankle arthroplasty\n* Patient is skeletally mature\n* Patient is mentally capable of completing follow-up forms\n* Patient will be available for follow-up out to 10 years\n* Patient has been deemed a candidate for Ankle replacement by diagnosis of the investigator\n* Patient is willing and able to read and sign a study informed consent form\n\nExclusion Criteria:\n\n* Patient with excessive bone loss at the ankle joint site\n* Patient with severe osteoporosis\n* Patient with complete talar avascular necrosis\n* Patient with Active Osteomyelitis\n* Patient with Infection at the ankle site or infection at distant sites that could migrate to the ankle\n* Patient with Sepsis\n* Patient with Vascular deficiency in the involved limb\n* Patient with Neuromuscular inadequacy (e.g. Prior paralysis, fusion and or inadequate abductor strength)\n* Patient with Neuropathic joints\n* Patient with Neurological or musculoskeletal disease or loss of function that may adversely affect movement of the lower limb, gait, or weight bearing\n* Patient with Poor soft tissue coverage around the ankle\n* Patient with Charcot arthropathy\n* Previous ankle arthrodesis with excision of the malleoli\n* Excessive loads as caused by activity or patient weight - per investigator discretion\n* Skeletally immature patients (patient is less than 21 years if age at time of surgery)\n* Patient with dementia\n* Patient with known metal allergies\n* Patient who is pregnant",{"count":76,"type":20},370,"The objectives of this study are to evaluate the performance and safety of the Vantage Total Ankle System. This study will follow subjects for a period of up to 10 years post-surgery.",[79,57,58],"Ankle Rheumatoid Arthritis",{"date":61,"type":37},{"date":82,"type":37},"2017-04-04",{"date":65,"type":20},{"name":43,"class":44},{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":103,"locationsCount":104},"100486529","comparison-between-exactech-guided-personalized-surgery-gps-and-conventional-instrumentation-of-shoulder-arthroplasty-100486529","NCT05615259","Comparison Between Exactech Guided Personalized Surgery (GPS) and Conventional Instrumentation of Shoulder Arthroplasty","A Prospective, Multi-Center, Randomized Clinical Study of Total Shoulder Arthroplasty Comparing Exactech Guided Personalized Surgery (GPS) vs. Conventional Instrumentation","Inclusion Criteria:\n\n* Patient is at least 21 years of age at the time of surgery\n* Patient is indicated for reverse shoulder arthroplasty\n* Patient is willing to participate by complying with pre- and postoperative visit requirements\n* Patient is willing to participate for the entire length of the prescribed follow-up (minimum 2 years)\n* Patient is willing and able to review and sign a study informed consent form\n* Preop CT scan is within 3 months of the date of surgery\n\nExclusion Criteria:\n\n* Revision shoulder arthroplasty\n* Reverse shoulder arthroplasty for fracture\n* Need for structural glenoid bone graft\n* Osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, implantation should be delayed until infection is resolved\n* Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis\n* Neuromuscular disorders that do not allow control of the joint\n* Significant injury to the brachial plexus\n* Non-functional deltoid muscles\n* The patient is unwilling or unable to comply with the post-operative care instructions\n* Patients who are a known drug or alcohol abuser, or have a psychological disorder (e.g. schizophrenia major depression, bipolar disorder, etc.) as defined by the DSM4 that affect follow-up care or treatment outcomes.\n* Alcohol, drug, or other subtance abuse\n* Any disease state that could adversaly affect the function or longevity of the implant\n* Patient is pregnant\n* Patient is a prisoner\n* Patient who are currently involved in any personal injury litigation, medical-legal or worker's compensation claims",{"count":93,"type":20},260,"The primary objective of this study is to examine the optimization of Reverse Shouder Arthroplasty implant position between GPS and conventional techniques. The secondary objective is to assess the effect of implant position using GPS vs. conventional techniques on ROM and patient reported outcomes. Long-term follow-up to 10 years with minimum 2 year follow-up for patients.",[96,97],"Technology","Comparison",{"date":99,"type":37},"2025-02-28",{"date":101,"type":37},"2020-09-23",{"date":65,"type":20},{"name":43,"class":44},1,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":104},"100493346","exactech-proximal-humerus-fracture-plate-system-post-market-clinical-follow-up-100493346","NCT05703958","Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up","An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Equinoxe Proximal Humerus Fracture Plates Clinical and Radiographic Outcomes","Inclusion Criteria:\n\n* Patient is indicated to receive Equinoxe Proximal Humerus Fracture Plate or has previously underwent primary surgery with Equioxe Proximal Humerus Fracture Plate\n* Patient is willing to participate by complying with pre- and postoperative visit requirements\n* Patient is willing to agree to be followed for up to 10 years following their index surgery\n* Patient is willing and able to review and sign a study informed consent form\n\nExclusion Criteria:\n\n* Osteomyelitis of the proximal humerus or scapula\n* Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis\n* Patient's age, weight, or activity level would cause the surgeon to expect early failure of the system\n* The patient is unwilling or unable to comply with the post-operative care instructions\n* Alcohol, drug, or other subtance abuse\n* Any disease state that could adversaly affect the function or longevity of the implant\n* Patient is pregnant\n* Patient is a prisoner\n* Patient has a physical or mental condition that would invalidate the results",{"count":113,"type":20},151,"The objective of this study is to collect and evaluate long-term clinical outcomes data in order to better understand the safety and performance of the Equinoxe Proximal Humerus Fracture Plates over time. This study will follow subjects for a period of up to 10 years post-surgery.",[116,117,118],"Proximal Humeral Fracture","Fracture Dislocation","Non-Union Fracture","2024-10-23",{"date":121,"type":37},"2024-10-24",{"date":123,"type":37},"2023-04-19",{"date":125,"type":20},"2034-09-30",{"name":43,"class":44},{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":16,"minAge":134,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":104},"100504563","exactech-hip-systems-post-market-clinical-follow-up-pmcf-100504563","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)","18 Years",{"count":136,"type":20},2946,"A Post-Market Domestic (US) and International Data Collection to Assess Exactech Hip Systems",[139],"Hip Arthroplasty, Total","2024-06-17",{"date":142,"type":37},"2024-06-18",{"date":144,"type":37},"2023-10-13",{"date":146,"type":20},"2036-12-31",{"name":43,"class":44},{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":16,"minAge":134,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":160,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},"100489437","a-post-market-domestic-us-and-international-data-collection-to-assess-the-truliant-knee-system-100489437","NCT05653102","A Post-Market Domestic (US) and International Data Collection to Assess the Truliant Knee System","CR17-003 Truliant Knee PMCF: A Post-Market Domestic (US) and International Data Collection to Assess the Truliant Knee System","Inclusion Criteria:\n\nCohort 1. Prospective \u002F Subjects- Enrolled in the study pre-surgery\n\n1. Subjects who agree to participate in the study that have not had surgery prior to being enrolled in the study.\n2. Skeletally mature (18 years of age or older).\n3. Subject is willing and able to provide written informed consent for participation in the study.\n4. Subject is to receive a Truliant® total knee replacement for Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-Traumatic Arthritis, Polyarthritis, Primary Implantation Failure, or as a Conversion of Uni-Compartmental Knee.\n5. The knee replacement will be performed by the investigator or a surgeon sub-investigator.\n6. The devices will be used according to the approved indications.\n\nCohort 2. Retrospective to Prospective \u002F Subjects enrolled in the study post- surgery then continue to participate in the study prospectively.\n\n1. 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).\n2. Skeletally mature (18 years of age or older).\n3. Subject is willing and able to provide written informed consent for participation in the study.\n4. Subject received a Truliant® total knee replacement for Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-Traumatic Arthritis, Polyarthritis, Primary Implantation Failure, or as a Conversion of Uni-Compartmental Knee.\n5. The knee replacement was performed by the investigator or a surgeon sub-investigator.\n6. The devices are\u002Fwere used according to the approved indications.\n\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 Truliant® knee 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: Pre-Operative:\n\n     o Demographic Data\n     1. Gender\n     2. Age at surgery\n     3. Height\u002FWeight\n     4. Indication for surgery\n     5. Prior Injuries\u002FSurgeries on index knee\n     6. Comorbidities\n   * Operative:\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. Retrospective Only Subjects enrolled in the study post-study surgery with no intent to continue as prospective subjects. Note: 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.\n\n1. Skeletally mature at the time of the surgery (18 years of age or older).\n2. The 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.\n3. The patients clinical record includes a documented procedure that includes, or is related to, TKA with a Truliant® Knee system device.\n4. The knee replacement was performed by the investigator or a surgeon sub-investigator.\n5. The devices are\u002Fwere used according to the approved indications.\n6. 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 Truliant® knee prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA). Prior to inclusion in the study, the following details must be available for submission:\n\n   * Pre-Operative:\n\n     * Demographic Data\n     * Gender\n     * Age at surgery\n     * Height\u002FWeight\n     * Indication for surgery\n     * Prior Injuries\u002FSurgeries on index knee\n     * Comorbidities\n   * Operative:\n\n     * Date of Surgery\n     * Type of Surgery (Primary \u002F Revision)\n     * All component product information, including catalogue reference numbers 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 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)",{"count":156,"type":20},1000,"A Post-Market Domestic (US) and International Data Collection to Assess the Truliant® Knee System",[159],"Knee Arthroplasty, Total",{"date":142,"type":37},{"date":162,"type":37},"2019-01-23",{"date":164,"type":20},"2035-07-31",{"name":43,"class":44},5,{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":174,"sex":16,"minAge":134,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":177,"phases":178,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":182,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":104},"100478930","evaluation-of-navigation-assisted-tka-using-mechanical-vs-restricted-kinematic-alignment-100478930","NCT05516381","Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment","Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment on Patient Reported Outcome Measures (PROMs): A Prospective, Randomized Clinical Study","Inclusion Criteria:\n\n* Subjects must meet all of the following inclusion criteria to be included in the study:\n\n  1. Subject must be at least 18 years of age at the time of the surgery (skeletally mature)\n  2. Subject will receive a Optetrak Logic® CR device per the \"Indications for Use\" described above\n  3. Subject must be willing to comply with the pre-operative and post-operative visit requirements\n  4. Subject must be willing and able to provide written informed consent for participation in the study\n\nExclusion Criteria:\n\n* Subjects will be excluded from the study if they meet any of the following exclusion criteria:\n\n  1. Subject with a suspected or confirmed systemic infection and\u002For a secondary remote infection\n  2. Subject without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis\n  3. Subject without sufficient soft tissue integrity to provide adequate stability\n  4. Subject with either mental or neuromuscular disorders that do not allow control of the knee joint\n  5. Subjects whose weight, age, or activity level might cause extreme loads and early failure of the system\n  6. Subject is participating in another drug or device study other than knee replacement within the last three (3) months\n  7. Subject has behavioral and\u002For mental issues that may interfere with their ability to follow post-operative instructions\n  8. Subject is a prisoner\n  9. Subject is pregnant\n  10. Subject is undergoing radiation therapy where the targeted field involves the knee joint\n  11. Subjects with malignancy involving proximal tibia, distal femur, or knee joint\n  12. Subjects undergoing active administration of chemotherapy",true,{"count":176,"type":20},148,"INTERVENTIONAL",[179],"NA","The purpose of this study is to evaluate both clinical measures and PROMs in patients undergoing total knee arthroplasty (TKA) using restricted inverse kinematic alignment (iKA) compared to mechanical alignment (MA), both using surgical navigation assistance.",[159],{"date":142,"type":37},{"date":184,"type":37},"2023-05-15",{"date":186,"type":20},"2027-06",{"name":43,"class":44},""]