[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"traumatic-arthritis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:traumatic-arthritis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,45,77,102,124,146,178],{"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":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":65,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100499789","persona-osseoti-keel-compatibility-study-total-knee-arthroplasty-100499789","NCT05787821","Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)","Persona® OsseoTi® Keel Compatibility Study-A Multicenter Cohort Study A Prospective, Post-market Clinical Follow-up Study to Demonstrate Safety, Performance and Clinical Benefits of the Persona Knee System Portfolio and Its Instrumentation","Inclusion Criteria:\n\n1. Patient is of legal age and skeletally mature\n2. Patient is willing and able to provide written Informed Consent by signing and dating the Institutional Review Board (IRB) \u002F Ethics Committee (EC) approved Informed Consent document\n3. Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol\n4. Independent of study participation, patient qualifies for either cemented or cementless primary or revision total knee arthroplasty (including salvage of previously failed surgical attempts) based upon physical exam and medical history, and meets the approved indications for use of the commercially available Persona Knee System with appropriately matched Zimmer Biomet components implanted in accordance with product labeling\n\nExclusion Criteria:\n\n1. Patient is currently participating in any other surgical intervention or pain management study\n2. Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent)\n3. Patient has a mental or neurological condition who is unwilling or incapable of following postoperative care instructions\n4. Patient has a condition which would, in the judgment of the investigator, place the patient at undue risk or interfere with the conduct of the study\n5. Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation\n6. Patient is scheduled to undergo simultaneous bilateral total knee arthroplasty\n7. Previous history of infection in the affected joint and\u002For other local\u002Fsystemic infection that may affect the prosthetic joint\n8. Insufficient bone stock on femoral or tibial surfaces\n9. Neuropathic arthropathy\n10. Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb\n11. A stable, painless arthrodesis in a satisfactory functional position\n12. Severe instability secondary to the absence of collateral ligament integrity\n13. Rheumatoid Arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin\n14. Patient has a \\> 5˚ valgus deformity with a medial collateral ligament (MCL) insufficiency, and the surgeon intends to use the personalized alignment surgical technique","18 Years",{"count":54,"type":20},760,"OBSERVATIONAL","The main objective of the study is to evaluate the safety, performance and clinical benefits of the Persona implant and its instrumentation in primary total knee arthroplasty",[58,59,28,27,60,61,62,63,64],"Knee Pain Chronic","Osteoarthritis, Knee","Polyarthritis","Varus Deformity","Valgus Deformity","Flexion Deformity of Knee","Avascular Necrosis",[26,66],"Total Knee Arthroplasty","2026-01-15",{"date":69,"type":36},"2026-01-20",{"date":71,"type":36},"2023-06-28",{"date":73,"type":20},"2035-06",{"name":75,"class":43},"Zimmer Biomet",16,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100266486","the-medacta-international-sms-post-marketing-surveillance-study-100266486","NCT02748408","The Medacta International SMS Post-Marketing Surveillance Study","The Medacta SMS Femoral Stem Component. A Multi-National, Multi-Centre, Clinical Surveillance Study","Inclusion Criteria:\n\n* Individuals with a severely painful and\u002For disabling hip joint with osteoarthritis, traumatic arthritis or developmental dysplasia of the hip or avascular necrosis of the femoral head.\n* In order to take part in this study, all study participants must be between the ages of 18 and 75 years of age, at the time of surgery.\n* Scheduled for a primary total hip replacement.\n\nExclusion Criteria:\n\n* Active infection\n* Pregnancy\n* Mental illness where the known condition is likely to compromise the patient's ability to consent, affect the patient's assessment of their progress or complete the 10 year cycle of follow-up appointments and reviews\n* Grossly distorted anatomy (surgeon's discretion)\n* Osteomalacia where uncemented implant fixation is contraindicated\n* Active rheumatoid arthritis.\n* Osteoporosis\n* Metabolic disorders which may impair bone formation where uncemented implant fixation is contraindicated\n* Muscular atrophy or neuromuscular disease\n* Allergy to implant material\n* Any patient who cannot or will not provide informed consent for participation in the study\n* Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems","75 Years",{"count":86,"type":20},550,"This is a Post-Marketing Surveillance of SMS femoral stem prosthesis.",[89,27,90,91,30],"Arthrosis","Rheumatoid Polyarthritis","Congenital Hip Dysplasia","2025-09-23",{"date":94,"type":36},"2025-09-29",{"date":96,"type":4},"2015-07",{"date":98,"type":20},"2032-07",{"name":100,"class":43},"Medacta International SA",4,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":123},"100558071","post-market-clinical-follow-up-keriflex-100558071","NCT06546345","Post Market Clinical Follow-Up KeriFlex®","Effectiveness and Safety of the Silicone Joint Implant KeriFlex® and of Its Associated Instruments in the Treatment of MCP and PIP Arthritis: Post Market Clinical Follow up","Inclusion Criteria:\n\n* Adult patients (age ≥ 18 years)\n* Patients who are going to undergo arthroplasty of the metacarpophalangeal or proximal interphalangeal joint using a KeriFlex® implant in accordance with the instructions for use and the labelling in force.\n* Patients with rheumatoid arthritis, osteoarthritis or post-traumatic osteoarthritis\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Patients with an intellectual disability who cannot follow their surgeon's instructions\n* Patients with general surgery contraindications and particularly to the implantation of a KeriFlex® implant\n* Patients with acute or chronic, local or systemic infections\n* Metacarpal or phalanx destruction or poor bone quality preventing adequate fixation\n* Muscle loss, alteration or vascular deficiency in the affected finger\n* Patients with significant physical activity involving treated joint\n* Children, young growing patients with open epiphyses",{"count":110,"type":20},86,"The general objective of this study is to assess the performance and safety of the KeriFlex® silicone joint implant and its associated instruments, used in accordance with the labeling and instructions in force.\n\nThe performance and safety of the KeriFlex® joint implant will be established in the short and long term with regard to the life cycle of the implant.",[28,113,27],"Degenerative Arthritis","2025-09-04",{"date":116,"type":36},"2025-09-11",{"date":118,"type":36},"2023-11-14",{"date":120,"type":20},"2035-01",{"name":122,"class":43},"Keri Medical SA",3,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":21,"phases":133,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},"100491446","hydrogel-coating-to-reduce-post-surgical-infection-after-joint-arthroplasty-100491446","NCT05679232","Hydrogel Coating to Reduce Post-surgical Infection After Joint Arthroplasty","Randomized, Controlled, Monocentric, Feasibility Clinical Investigation to Assess the Safety and Preliminary Clinical Performance of a Hydrogel Coating to Reduce Post-surgical Infection After Joint Arthroplasty","Inclusion Criteria:\n\n* Informed Consent signed by the subject\n* Males and females aged over 18 years at time of surgery\n* Subjects who are scheduled to receive a conical collarless cementless revision hip arthroplasty, with or without revision of the acetabular cup\n* Subjects willing to comply with the pre- and post-operative evaluation schedule\n\nExclusion Criteria:\n\n* Subjects with one or more medical conditions identified as a contraindication defined by the labelling on any implants used in this study\n* Subjects with immune suppressive treatment for organ transplantation, or known allergy to MectaShield hydrogel constituents (Chitlac, Mannitol, Hydroxypropylmethylcellulose, Sodium phosphate dibasic)\n* Subjects presenting with progressive local or systemic infection at the time of surgery\n* Subjects whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems\n* Subjects affected by concomitant spine, hip, ankle or contralateral knee pathologies that can affect walking capacity\n* Subjects unable to understand and take action\n* Subjects undergoing cementless revision hip arthroplasty in emergency interventions",{"count":132,"type":20},56,[23],"The goal of this randomized, controlled, monocentric, single-blind, 2-arm, feasibility clinical investigation is to evaluate the safety of MectaShield hydrogel coating and to capture its preliminary clinical performance in the prevention of early peri-prosthetic joint infection (PJI) in patients undergoing cementless revision hip arthroplasty.\n\nThe main questions it aims to answer are:\n\n* demonstrate that the hydrogel coating MectaShield does not interfere with primary stability;\n* evaluate clinical and functional outcomes, the rate of PJI and possible adverse events.\n\nParticipants will undergo cementless revision hip arthroplasty; during surgery MectaShield hydrogel coating is applied on orthopaedic implants' surfaces (femoral stem and, if revised, acetabular cup) as a protective barrier for the prevention of bacterial adhesion. Surgery and follow-up are completed as per local standard practice. Stability will be assessed radiologically, while functional outcomes and PJI will be monitored by HOOS-PS, ASESPIS scores and according to the consensus document presented by European Society of Radiology (ESRa), the European Association of Nuclear Medicine (EANM), the European Bone and Joint Infection Society (EBJIS), and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID). Researchers will compare the results of the treatment group with those from a control group receiving cementless revision hip arthroplasty without the application of MectaShiled hydrogel coating.",[136,27,64],"Arthritis","2025-05-07",{"date":139,"type":36},"2025-05-11",{"date":141,"type":36},"2022-12-06",{"date":143,"type":20},"2027-12-06",{"name":100,"class":43},1,{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":16,"minAge":153,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":21,"phases":156,"briefSummary":157,"conditions":158,"keywords":161,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":44},"100289472","physica-system-total-knee-replacement-registry-study-100289472","NCT03048201","Physica System Total Knee Replacement Registry Study","Post-market Registry Study on the Physica System Total Knee Replacement","Inclusion Criteria:\n\n1. Males and females of any race requiring a total knee replacement and suitable for the use of one of the configurations of the Physica system\n2. Age\\> 22 (skeletally mature)\n3. Patients who are suffering from non-inflammatory degenerative joint disease (NIDJD):\n\n   including knee osteoarthritis, post-traumatic knee arthritis; or patients who are suffering from inflammatory arthritis; or patients that need correction of a functional deformity\n4. Suitable candidates for TKR who have undamaged and functional collateral ligaments\n5. Suitable candidates for TKR with Physica KR, CR, who have an undamaged and functional posterior cruciate ligament; or Physica LMC with or without a functioning posterior cruciate ligament or Physica PS with an absent or not-functioning posterior cruciate ligament and\u002For severe antero-posterior instability of the knee joint\n6. Patients who understand the conditions of the study and are willing and able to comply with the prescribed rehabilitation and to perform all scheduled follow-up visits\n7. Patients who have signed the Ethics Committee\u002FIRB approved study-specific Informed Consent Form prior to the surgery\n\nExclusion Criteria:\n\n1. Patients with severe instability of the knee joint secondary to the absence of collateral ligament integrity and\u002For function\n2. Patients with active or any suspected infection (on the affected knee or systemic)\n3. Previous partial knee replacement (unicompartimental, bicompartimental or patellofemoral joint replacement), patellectomy, high tibial osteotomy\n4. Patients with significant bone loss on femoral or tibial joint side\n5. Current treatment for malignant and\u002For life-threatening non-malignant disorders\n6. Patients with known incompatibility or allergy to the product materials, and\u002For metal hypersensitivity to implant materials\n7. Vascular insufficiency of lower limbs severe enough to interfere with the study evaluation\n8. Patients with bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and\u002For fixation to the prosthesis\n9. Patients with systemic or metabolic disorders leading to progressive bone deterioration which may impair fixation and stability of the implant\n10. Any concomitant disease and dependence that might affect the performance of the implanted prosthesis\n11. Any clinically significant pathology based on clinical history that the Investigator feels may affect the study evaluation (e.g. primary osteoporosis with significant bone loss, haemophilic disease, septicaemia, persistent acute or chronic osteomyelitis)\n12. Patients who have significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery and evaluation\n13. Patients who have neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device\n14. Previous history of infection in the affected joint and\u002For other local\u002Fsystemic infection that may affect the prosthetic joint\n15. Any psychiatric illness that would prevent comprehension of the details and nature of the study\n16. Patients currently participating in any other surgical intervention studies or pain management studies\n17. Female patients who are pregnant, nursing, or planning a pregnancy","22 Years",{"count":155,"type":20},800,[23],"The primary objective of this study is to obtain long-term implant survivorship (out to 10 years) and to assess clinical, patient-reported outcome measures, and radiographic data for the commercially available Physica system. For ancillary arm, from baseline to 5-year follow-up.",[59,27,64,159,28,160],"Degenerative Joint Disease of Knee","Deformity of Knee",[162,163,164,165,166,167,168],"Physica KR","Physica CR","Physica PS","Kinematic Retaining","Cruciate Retaining","Posterior Stabilized","Physica System","2023-03-17",{"date":171,"type":36},"2023-03-21",{"date":173,"type":36},"2017-03-24",{"date":175,"type":20},"2030-03",{"name":177,"class":43},"Limacorporate S.p.a",{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":185,"sex":16,"minAge":186,"maxAge":84,"enrollmentInfo":187,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":194,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":4},"100433020","prospective-post-market-study-examining-the-effectiveness-of-the-ecofit-100433020","NCT04918680","Prospective Post-market Study Examining the Effectiveness of the EcoFit®","Prospective Post-market Study Examining the Effectiveness of the EcoFit® Total Hip System With Implacross® E Polyethylene","Inclusion Criteria:\n\n* Subject must be a candidate for a total primary hip replacement.\n* Subject must have degenerative joint disease, including osteoarthritis or traumatic arthritis, OR a femoral fracture which can be treated by a primary hip replacement and no other hardware\n* Subject has a BMI of 40.00 kg\u002Fm2 or less at the time of enrollment\n* Subject is likely to be available for evaluation for the duration of the study\n* Subject is able and willing to sign the informed consent and follow study procedures\n* Subject is not pregnant\n\nExclusion Criteria:\n\n* Subject has had a prior hip replacement in the subject hip\n* Subject has an active cancer or is a survivor for \\\u003C5 years except for squamous cell or basal cell skin cancer\n* Subject has a chronic disease(s) where, in the opinion of the investigator, the disease will interfere with the patient's ability to follow the protocol\n* Subject is currently a documented substance abuser (alcohol or other addictions)\n* Subject has an infection, or history of infection (within the last 3 months), acute or chronic, local or systemic\n* Subject has a history of muscular, neurological or vascular deficiencies which compromise the affected extremity\n* Subject has a BMI \\> 40.00 kg\u002Fm2\n* Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)\n* Subject is a prisoner\n* Subject is pregnant\n* Subject has known materials sensitivity (to metals)",true,"40 Years",{"count":188,"type":20},500,"The purpose of this study is to evaluate the safety and effectiveness of the EcoFit Hip with implacross E polyethylene for total hip replacement surgery.",[191,192,193,27],"Degenerative Joint Disease","Femoral Fracture","Osteoarthritis, Hip","NOT_YET_RECRUITING","2021-06-01",{"date":197,"type":36},"2021-06-09",{"date":199,"type":20},"2021-06-21",{"date":201,"type":20},"2027-03-30",{"name":203,"class":43},"Implantcast North America, LLC"]