[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"knee-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:knee-disease":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,84],{"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":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100425529","persona-revision-knee-system-outcomes-100425529",false,"NCT04821154","Persona Revision Knee System Outcomes","Clinical Investigation to Demonstrate Performance, Safety and Clinical Benefits of the Persona Revision Knee System","Inclusion Criteria:\n\n1. Male or female of at least 18 years of age at the time of screening.\n2. Signed an institutional review board approved informed consent.\n3. Willingness and ability to comply with the study procedures and visit schedules and ability to understand and follow oral and written post-operative care instructions.\n4. Previous medical diagnosis\u002F history of at least one of the following conditions requiring treatment using the Persona Revision Knee System within a pre-specified study variant configuration (cohort), in accordance with the instructions for use (IFU):\n\n   1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis or polyarthritis\n   2. Collagen disorders, and\u002For avascular necrosis of the femoral condyle\n   3. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy\n   4. Moderate valgus, varus, or flexion deformities\n   5. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery\n5. A pre-operative Knee Society Knee Score (objective assessment) ≤ 80.\n\nExclusion Criteria:\n\n1\\) Presence of clinically observed active or suspected latent infection in the affected joint at the time of procedure.\n\n3\\) Presence of of local\u002Fsystemic\u002Fdistant focal infection that may affect or hematogenously spread to the prosthetic joint.\n\n4\\) Skeletal immaturity or insufficient bone stock on femoral or tibial surfaces which cannot provide adequate support and\u002For fixation to the prosthesis.\n\n5\\) Diagnosed with neuropathic arthropathy, osteoporosis, or any loss of musculature or neuromuscular disease that compromises the affected limb.\n\n6\\) Presence of a stable, painless arthrodesis in a satisfactory functional position in the affected joint.\n\n7\\) Severe instability of the affected joint secondary to the absence of collateral ligament integrity.\n\n8\\) Diagnosis of rheumatoid arthritis in conjunction with any of the following at the time of screening:\n\n1. An ulcer of the skin\n2. History of recurrent breakdown of the skin\n3. Use of steroids\n\n   9\\) Patient requires simultaneous bilateral knee surgery for treatment of diagnosed condition.\n\n   10\\) Pregnant or women planning to become pregnant during the time they will be participating in the study.\n\n   11\\) Any documented clinically significant degree of cognitive impairment or other condition, finding, or psychiatric illness at screening which, in the opinion of the Investigator, could compromise patient safety or interfere with the assessment of the safety and treatment effects of the study procedure.\n\n   12\\) Any patient who is institutionalized, or with a known drug or alcohol dependence currently or within the last year.","ALL","18 Years",{"count":19,"type":20},380,"ESTIMATED","OBSERVATIONAL","The study will evaluate the performance, clinical benefits and safety of the Persona Revision Knee System in patients who have received primary or revision total knee arthroplasty (TKA) treatment. This will be done using a multicenter, single-arm, consecutive series, retrospective cohort study with prospective follow-up.",[24,25,26,27],"Arthroplasty Complications","Infection","Knee Disease","Knee Osteoarthritis",[29,30,31,32,33,34,35],"Revision","Total Knee","Medical Device","Safety","Performance","Primary","Clinical Benefits","RECRUITING","2025-10-22",{"date":39,"type":40},"2025-10-24","ACTUAL",{"date":42,"type":40},"2021-06-14",{"date":44,"type":20},"2027-12-31",{"name":46,"class":47},"Zimmer Biomet","INDUSTRY",16,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":70,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":83},"100424990","prospective-functional-gait-and-outcome-comparison-study-of-medial-pivot-versus-single-radius-design-for-total-knee-arthroplasty-100424990","NCT04814082","Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot Versus Single Radius Design for Total Knee Arthroplasty","Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot","Inclusion Criteria:\n\n* Subject is male or non-pregnant female aged between 18 and 75 years of age.\n* Subject is willing to provide informed consent to participate in the research study.\n* Subject is indicated for a primary total knee arthroplasty (TKA) based on the approved labeling of knee implant, either a medial pivot or single radius design, specifically: MicroPort Evolution Medial-Pivot Knee System, Cruciate Retaining (CS) or Stryker Triathlon Tritanium (CS)\n* Subject does not have a history of previous prosthetic replacement device on the operative knee.\n* Subject is currently ambulating and does not have a condition on the contralateral limb in the opinion of the investigator that would interfere with the gait laboratory evaluations.\n* Subject is willing and able to comply with the schedule of events for the study and is available to return to the clinic for all required follow-up visits.\n\nExclusion Criteria:\n\n* Subject has a Body Mass Index (BMI) \\>40\n* Subject has a diagnosis of avascular necrosis or inflammatory arthritis.\n* Subject has any mental or neuromuscular disorder that would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.\n* Subject is a prisoner\n* Subject has any condition, in the opinion of the Investigator that might interfere with the evaluation of the study objectives.","75 Years",{"count":58,"type":20},100,"INTERVENTIONAL",[61],"NA","Patients with degenerative joint disease can effectively be treated with a primary total knee replacement to reduce pain and improve function in their daily lives. Theoretically, achievement of normal knee motion using a medial pivot design in total knee replacements can be recreated in comparison to single radius designs, which could lead to an improvement in post-surgical outcomes and satisfaction with the procedure. The aim of this study is to compare two types of implant designs (medial pivot and single radius) in a total knee replacement using clinical outcomes, patient reported outcomes, and overall function assessed by a specialized gait laboratory.",[64,27,65,66,67,68,26,69],"Osteoarthritis, Knee","Osteoarthritis Knees Both","Osteoarthritis Knee Left","Osteoarthritis Knee Right","Knee Pain Chronic","Arthropathy of Knee Joint",[71,72],"Total Knee Arthroplasty","Total Knee Replacement","2025-01-20",{"date":75,"type":40},"2025-01-22",{"date":77,"type":40},"2021-02-01",{"date":79,"type":20},"2030-07-01",{"name":81,"class":82},"LifeBridge Health","OTHER",1,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":59,"phases":94,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":4},"100537976","comparison-of-two-robotic-assisted-total-knee-arthroplasty-systems-100537976","NCT06284824","Comparison of Two Robotic-Assisted Total Knee Arthroplasty Systems","Prospective, Randomized, Single-center Study Comparing the Stryker MAKO™ Robotic-Arm Assisted Total Knee Arthroplasty and the DePuy VELYS™ Robotic-Assisted Solution for Total Knee Arthroplasty.","Inclusion Criteria:\n\n* Patient must be a candidate for primary TKA (either Stryker Triathlon with MAKO Robotic-Arm or DePuy Attune with VELYS Robotic-Assistance).\n* Individuals who are able to speak, read, and comprehend the Institutional Review Board approved Informed Consent Document and willing and able to provide informed patient consent for participation in the study and have authorized the transfer of information to the Sponsor.\n* Individuals who are willing and able to complete follow up visits, questionnaires, and radiographic evaluations as specified by the study protocol.\n* Individuals who are male or non-pregnant female age 18-80 years at time of device implantation.\n* Patient has a diagnosis of primary osteoarthritis or degenerative joint disease of the knee.\n\nExclusion Criteria:\n\n* Patient has a Body Mass Index (BMI) \\> 40.\n* Patient has been diagnosed with osteoporosis or displays poor bone quality per the discretion of the investigator.\n* Patient has an active or suspected latent infection in affected knee joint. Patient has neuromuscular or neurosensory deficiency.\n* Patient is diagnosed with systemic disease or metabolic disorder (e.g., Lupus, Charcot's. Paget's).\n* Subject is a woman who is pregnant or lactating.\n* Patient has a contralateral amputation.\n* Patient's affected knee has a flexion contracture greater than 15 degrees.\n* Patient has history of post operative arthrofibrosis.\n* Patient's affected knee has a partial knee arthroplasty.\n* Patient has undergone contralateral TKA within the last three months.\n* Patient is currently involved in any personal injury litigation, medical-legal, or worker's compensation claims.\n* Patient who is bedridden per the discretion of the investigator.\n* Patient has a medical condition with less than 2 years of life expectancy.","80 Years",{"count":93,"type":20},120,[61],"The goal of this prospective study is to compare two different knee replacement robots. This study will look at patient reported outcome measures and data collected during the operation. The main questions this study aims to answer include:\n\n* Will the patient reported outcomes differ between the two groups?\n* Will the intraoperative data differ between the two groups? Participants will undergo total knee replacement with one of the two robots, complete standardized surveys, and have x-rays taken.",[27,97,26],"Knee Arthritis",[99,100,101],"robotic assistance","arthroplasty","TKA","NOT_YET_RECRUITING","2024-04-15",{"date":105,"type":40},"2024-04-17",{"date":107,"type":20},"2024-05",{"date":109,"type":20},"2027-05",{"name":111,"class":112},"Southeast Orthopedic Specialists","NETWORK"]