[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Zimmer Biomet\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":601},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,23,0,[8,47,71,91,125,149,171,191,215,240,269,293,316,341,360,383,410,453,480,503,531,556,578],{"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":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100586828","zimmer-biomet-shoulder-arthroplasty-pmcf-study-100586828",false,"NCT06920459","Zimmer Biomet Shoulder Arthroplasty PMCF Study","Zimmer Biomet Shoulder Arthroplasty Long-term Post Market Clinical Follow-up Study","Inclusion Criteria:\n\n* Patient must be 20 years of age or older.\n* Patient must be anatomically and structurally suited to receive shoulder arthroplasty implants.\n* Patient is a candidate for shoulder arthroplasty due to one or more of the following:\n\nNon-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.\n\nRheumatoid arthritis. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.\n\nDifficult clinical management problems, where other method of treatment may not be suitable or may be inadequate.\n\n* Patient must be able and willing to complete the protocol required follow-up.\n* Patient must be able and willing to sign the IRB\u002FEC approved informed consent.\n\nExclusion Criteria:\n\n* Patient is unwilling or unable to give consent or to comply with the follow-up program.\n* Patient has any condition which would in the judgement of the Investigator, place the patient at undue risk or interfere with the study.\n* Patient is known to be pregnant or breastfeeding.\n* Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, and\u002For anticipated to be non- compliant).\n* Patient is uncooperative or patient with neurologic disorders who is incapable or unwilling to follow directions.\n* Patient has any sign of infection affecting the shoulder joint or in its proximity which may spread to the implant site.\n* Patient has rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram.\n* Patient has any neuromuscular disease compromising the affected limb that would render the procedure unjustifiable.\n* Patient presents with osteoporosis, which in the opinion of the Investigator, may limit the subject's ability to support total shoulder arthroplasty using the study device.\n* Patient has a metabolic disorder that may impair bone formation.\n* Patient has osteomalacia.","ALL","20 Years",{"count":19,"type":20},50,"ESTIMATED","OBSERVATIONAL","This is a multicenter, prospective, non-controlled post market surveillance study. The objectives of this study are to confirm the safety, performance, and clinical benefits of the Zimmer Biomet Shoulder Arthroplasty systems in primary anatomic shoulder arthroplasty and its instrumentation. Safety of the systems will be assessed by monitoring the frequency and incidence of adverse events. The performance and clinical benefits will be evaluated by assessment of the overall pain and functional performance, qualify of life, and radiographic parameters of all enrolled study subjects.",[24,25,26,27,28,29],"Shoulder Fractures","Shoulder Arthritis Osteoarthritis","Shoulder Injury","Shoulder Pain","Degenerative Joint Disease","Arthritis Shoulder",[31,32,33],"medical device","PMCF","Anatomic Total Shoulder Arthroplasty","RECRUITING","2026-06-05",{"date":37,"type":38},"2026-06-08","ACTUAL",{"date":40,"type":38},"2025-04-29",{"date":42,"type":20},"2037-06",{"name":44,"class":45},"Zimmer Biomet","INDUSTRY",2,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100625331","osseofit-stemless-shoulder-system-anatomic-100625331","NCT07421245","OsseoFit Stemless Shoulder System (Anatomic)","OsseoFit Stemless Shoulder System (Anatomic) Post-Market Clinical Follow-up Study","Inclusion Criteria:\n\n* Patient must be 20 years of age or older.\n* The patient must be anatomically and structurally suited, as evident by scapula and proximal humerus closure, to receive the implants.\n* Patient planned to receive OsseoFit™ anchor with uncemented fixation.\n* Patient planned to receive a Modular Alliance Glenoid with bone cement. The porous posts must be coated with Porous Plasma Spray (PPS) and may be inserted without bone cement.\n* Patient planned to receive shoulder arthroplasty due to osteoarthritis.\n* Patient must be able and willing to complete the protocol required follow-up schedule.\n* Patient must be able and willing to sign the IRB approved consent.\n\nExclusion Criteria:\n\n* Patient is unwilling or unable to give consent or to comply with the follow-up program.\n* Patient has any condition which would in the judgement of the Investigator, place the patient at undue risk or interfere with the study.\n* Patient is known to be pregnant or breastfeeding.\n* Patient is a vulnerable participant (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, and\u002For anticipated to be non-compliant).\n* Patient is uncooperative or patient with neurologic disorders who is incapable or unwilling to follow directions.\n* Patient has any neuromuscular disease compromising the affected limb.\n* Patient has any sign of infection affecting the shoulder joint or in its proximity which may spread to the implant site. This may include:\n\n  * Local\u002Fsystemic infection\n  * Sepsis\n  * Osteomyelitis\n* Patient presents with Osteomalacia.\n* Patient presents with a humeral bone fracture.\n* Patient presents with malunion or non-union of the tuberosities of the proximal humerus.\n* Patient has had a previous operative shoulder prosthesis (stem or stemless).\n* Patient has irreparable cuff tear.\n* Patient presents with inadequate humeral bone, which in the opinion of the Investigator, may lead to poor implant fixation. This may include but is not limited to:\n\n  * Osteoporosis\n  * Extensive Avascular Necrosis\n  * Rheumatoid Arthritis\n  * Metaphyseal bony defects (including large cysts)",{"count":55,"type":20},136,"The purpose of this clinical research protocol is to evaluate the safety, efficacy, and long-term outcomes of the OsseoFit Stemless Shoulder System (Anatomic) in patients with a primary diagnosis of osteoarthritis. The study aims to assess the intraoperative characteristics, postoperative complications, functional outcomes, and radiographic findings associated with the use of the stemless implant system. Ultimately, this research aims to improve patient outcomes, enhance surgical techniques, and inform clinical decision-making in the treatment of shoulder pathology.",[58,27,24,59,60],"Shoulder Injuries","Shoulder Arthritis","Shoulder Disease","NOT_YET_RECRUITING","2026-04-22",{"date":64,"type":38},"2026-04-23",{"date":66,"type":20},"2026-04",{"date":68,"type":20},"2036-01",{"name":44,"class":45},1,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":46},"100576701","mdr---comprehensive-primary-revision-stems-pmcf-100576701","NCT06788717","MDR - Comprehensive Primary Revision Stems PMCF","Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Comprehensive® Primary Revision Stems (Implants and Instrumentation) - A Retrospective and Prospective Consecutive Series Study","Inclusion Criteria\n\n* Patient must be 18 years of age or older.\n* Patient must be willing and able to follow directions.\n* Study devices must have been implanted following the surgical technique and IFU for the Comprehensive Revision Stem\n\nExclusion Criteria\n\n* Off-label use.\n* Patient is a prisoner.\n* Patient is a current alcohol or drug abuser.\n* Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent.\n* Patient is unwilling to sign informed consent.\n* Uncooperative patient or patient with neurologic disorders who are incapable of following directions.","18 Years","100 Years",{"count":81,"type":20},59,"The objective of this retrospective and prospective consecutive series PMCF (Post Market Clinical Follow Up) study is to collect long-term data confirming safety, performance and clinical benefits of the Comprehensive Primary Revision Stems (implants and instrumentation) when used for shoulder arthroplasty at 1, 3, 5, 7 and 10 years.",[27,58,24,60,59],{"date":85,"type":38},"2026-04-28",{"date":87,"type":38},"2025-06-19",{"date":89,"type":20},"2040-12",{"name":44,"class":45},{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":14,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":106,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":118,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},"100438054","zimmer-biomet-shoulder-arthroplasty-pmcf-100438054","NCT04984291","Zimmer Biomet Shoulder Arthroplasty PMCF","Inclusion Criteria:\n\n* Patient must be 20 years of age or older.\n* Patient must be anatomically and structurally suited to receive shoulder arthroplasty implants.\n* Patient is a candidate for shoulder arthroplasty due to one or more of the following:\n\n  * Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.\n  * Rheumatoid arthritis.\n  * Correction of functional deformity.\n  * Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.\n  * Difficult clinical management problems, where other methods of treatment may not be suitable or may be inadequate.\n* Patient must be able and willing to complete the protocol required follow-up.\n* Patient must be able and willing to sign the IRB\u002FEC approved informed consent.\n* Patient has grossly deficient rotator, (for reverse application)\n\n  * With severe arthropathy and\u002For\n  * Previously failed shoulder joint replacement\n* Patient must have functional deltoid muscle (for reverse application)\n\nExclusion Criteria:\n\n* Patient is unwilling or unable to give consent or to comply with the follow-up program.\n* Patient has any condition which would in the judgement of the Investigator, place the patient at undue risk or interfere with the study.\n* Patient is known to be pregnant or breastfeeding.\n* Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, and\u002For anticipated to be non-compliant).\n* Patient is uncooperative or patient with neurologic disorders who is incapable or unwilling to follow directions.\n* Patient has any sign of infection affecting the shoulder joint or in its proximity which may spread to the implant site.\n* Patient has rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram.\n* Patient has any neuromuscular disease compromising the affected limb that would render the procedure unjustifiable.\n* Patient presents with osteoporosis, which in the opinion of the Investigator, may limit the subject's ability to support total shoulder arthroplasty using the study device.\n* Patient has osteomalacia.\n* Patient has a metabolic disorder that may impair bone formation.\n* Patient has deficient rotator cuff.\n* Patient presents with significant injury to the upper brachial plexus.\n* Patient has paralysis of the axillary nerve.\n* Patient has non-functional deltoid or external rotator muscles.",{"count":98,"type":20},584,"INTERVENTIONAL",[101],"NA","The objectives of this study are to confirm the safety, performance, and clinical benefits of Zimmer Biomet Shoulder Arthroplasty Systems and its instrumentation in primary or revision shoulder arthroplasty. These objectives will be assessed using standard scoring systems, radiographic evidence, and adverse event records. Safety of the system will be assessed by monitoring the frequency an incidence of adverse events.",[24,59,104,105,58,27],"Shoulder Osteoarthritis","Shoulder Deformity",[107,108,109,110,111,112,113,114,115,116,117],"Total Shoulder Arthroplasty","Glenoid","Humeral Stem","Stem Adapter","Humeral Head","Humeral Bearing","Humeral Trays","Head Adapter","Reverse","Anatomic","Hemi",{"date":85,"type":38},{"date":120,"type":38},"2021-07-28",{"date":122,"type":20},"2033-08-15",{"name":44,"class":45},17,{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":4,"enrollmentInfo":132,"targetDuration":134,"studyType":21,"phases":4,"briefSummary":135,"conditions":136,"keywords":139,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":70},"100630296","zimmer-biomet-ribfix-titan-100630296","NCT07485829","Zimmer Biomet-RibFix Titan","Zimmer Biomet Patient Outcomes and Experience After Chest Wall Repair With RibFix Titan™","Inclusion Criteria:\n\n1. At least 18 years of age\n2. Willing and able to sign an Institutional Review Board (IRB) approved Informed Consent Form and able to comply with study requirements, in the Investigator's opinion\n3. Independent of study participation, patient qualifies for fixation, stabilization, and\u002For fusion of rib fractures or osteotomies of normal and osteoporotic bone with the study device\n\nExclusion Criteria:\n\n1. Midline Sternotomy: sternotomy incisions crossing the midline\n2. Active Infection: patients should not have any ongoing infections\n3. Material Sensitivity: where sensitivity to materials is suspected, comprehensive testing should be conducted before implantation\n4. Inability to Adhere to Post-operative Care: Patients must have the ability and willingness to comply with post-operative care instructions, which may not be possible for individuals with certain mental or neurological conditions\n5. Patients not expected to survive the duration of follow-up due to the involvement of trauma situations\n6. Patients with a history of alcohol or substance abuse, as well as vulnerable populations such as prisoners and pregnant women",{"count":133,"type":20},54,"1 Year","Prospective, single-center, non-randomized, single-cohort, post-market clinical follow-up study to confirm the safety, performance, and clinical benefits for the use of the RibFix Titan™ system implants and instrumentation) in the fusion, stabilization, and fixation of fractures in the chest wall including rib reconstructive surgical procedures, trauma, or planned osteotomies.",[137,138],"Rib Fracture","Rib Fracture Multiple",[140],"RibFix Titan","2026-04-15",{"date":143,"type":38},"2026-04-21",{"date":145,"type":38},"2026-03-31",{"date":147,"type":20},"2028-03",{"name":44,"class":45},{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":70},"100513519","rosa-knee-intraoperative-planning-flexibility-study-100513519","NCT05966519","ROSA Knee Intraoperative Planning Flexibility Study","ROSA Knee Intraoperative Planning Flexibility on Japan Preferred Surgical Technique, A Single Center Prospective Study","IntraOP","Inclusion Criteria:\n\n* 20 years and over\n* Skeletally matured\n* Decision to have Total Knee Arthroplasty with ROSA Knee System being made independently and prior to recruitment into study\n* Willing and able to complete scheduled follow-up evaluations as described in the study protocol\n* Has participated in the informed consent process and is willing and able to sign an Institutional Review Board (IRB)\u002FEthics Committee (EC) approved informed consent form\n\nExclusion Criteria:\n\n* Has serious bone defect(s), which require(s) metallic augment, synthetic bone or allograft\n* Is septic, has an active infection or has osteomyelitis at the affected joint\n* Has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which might jeopardize the outcome of the surgery\n* Has any concomitant disease which is likely to jeopardize the functioning or success of the implant\n* Is known to be pregnant\n* Is a prisoner, known alcohol or drug abuser or mentally incompetent or unable to understand what participation in this study entails\n* Has a known sensitivity or allergy to one or more of the implanted materials",{"count":158,"type":20},80,"The purpose of this study is to verify that an orthopedic surgical assist robot (ROSA Knee System) can provide intraoperative adjustment of osteotomy angle and volume for total knee arthroplasty (TKA) based on feedbacks obtained from intraoperative soft tissue conditions. A total 80 cases will be enrolled at one study site with a postoperative follow-up period of 2 years.",[161,162],"Osteo Arthritis Knee","Rheumatoid Arthritis","2026-04-02",{"date":165,"type":38},"2026-04-08",{"date":167,"type":38},"2024-01-05",{"date":169,"type":20},"2029-01",{"name":44,"class":45},{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":70},"100599127","pmcf-study-on-the-safety-performance-and-clinical-benefits-data-of-the-compositcp-100599127","NCT07080450","PMCF Study on the Safety, Performance and Clinical Benefits Data of the ComposiTCP","Post-market Clinical Follow-up Study to Collect Safety, Performance and Clinical Benefits of the ComposiTCP™ Suture Anchors Double Loaded With BroadBand Tape, Sliding","Inclusion Criteria:\n\n* Subject was treated with the ComposiTCP Suture Anchors Double Loaded with BroadBand Tape, Sliding for rotator cuff repair;\n* At least 18 years old and skeletally mature;\n* Willing and able to comply with the study procedures;\n* Subject is capable of understanding the doctor's explanations, following his instructions and is able to participate in the follow-up program;\n* Subject is able to read and understand the ICF and has voluntarily provided written informed consent or non-opposition.\n\nExclusion Criteria:\n\n* Subject is vulnerable (is unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response);\n* The subject is unwilling or unable to give consent or to comply with the follow-up program;\n* Subject meets any contraindications of the appropriate Instruction for Use;\n* Off-Label Use.",{"count":179,"type":20},43,"The study is a multicenter, retrospective and prospective, non-randomized, noncontrolled, and consecutive series post-market study. The purpose of this study is collect data confirming safety, performance and clinical benefits of the ComposiTCP Suture Anchors Double Loaded with BroadBand Tape, Sliding implants when used in rotator cuff repair.\n\nThe primary endpoint of this study is the assessment of performance by analyzing soft tissue to bone healing in the shoulder (rotator cuff). Healing will be assessed by the investigator using PROMs and clinical outcomes of the patient.\n\nThe clinical benefit will be assessed by functional outcomes measured using standard and well-established scoring systems (e.g. Oxford Shoulder Score and EQ-5D-5L) at 1 year post-operative.\n\nThe safety will be assessed by monitoring the incidence and frequency of device- and\u002For procedure-related adverse events.",[182],"Rotator Cuff Repairs","2026-02-02",{"date":185,"type":38},"2026-02-03",{"date":187,"type":38},"2025-07-01",{"date":189,"type":20},"2026-08",{"name":44,"class":45},{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":200,"conditions":201,"keywords":203,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":208,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":214},"100460518","znn-bactiguard-retrograde-femoral-nails-pmcf-study-100460518","NCT05276674","ZNN Bactiguard Retrograde Femoral Nails PMCF Study","Post-Market Clinical Follow-up Study on the ZNN™ Bactiguard ® Retrograde Femoral Nails (Implants and Instrumentation)","Inclusion Criteria:\n\n* Patients must be 18 years or older.\n* Patient must have a femoral fracture (open, closed, monolateral or bilateral) requiring surgical intervention and be eligible for fixation by intramedullary nailing. Patients with delayed treatment (initial treatment by external fixation due to swelling \u002F high energy trauma followed by definitive treatment by intramedullary nail) can also be included.\n* Patient has been or is scheduled to be treated with the ZNN Bactiguard System Retrograde Femoral Nail.\n* Patient must be able and willing to complete the protocol required follow-up.\n* Patient must have a signed EC approved consent.\n* Patients capable of understanding the surgeon's explanations and following his instructions.\n\nExclusion Criteria:\n\n* Skeletally immature patients\n* A medullary canal obliterated by a previous fracture or tumor\n* Bone shaft having excessive bow or a deformity\n* Lack of bone substance or bone quality, which makes stable seating of the implant impossible\n* All concomitant diseases that can impair the operation, functioning or the success of the implant\n* Insufficient blood circulation\n* Infection\n* Patient is unwilling or unable to give consent.\n* Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, alcohol\u002Fdrug addiction, known to be pregnant or breast feeding).\n* Patient anticipated to be non-compliant and\u002For likely to have problems with maintaining follow-up program (e.g. patient with no fixed address, long distance, plans to move during course of study).\n* Not expected to survive the duration of the follow-up program",{"count":199,"type":20},100,"Post-market clinical follow-up (PMCF) study to confirm the safety, performance, and clinical benefits of the intra-medullary retrograde femoral nail Zimmer Natural Nail (ZNN) Bactiguard (implants and instrumentation) when used for the temporary internal fixation and stabilization of femoral fractures.",[202],"Femoral Fracture",[204,205,206,207],"Bactiguard","Femur fracture","Intramedullary nailing","Infection control",{"date":185,"type":38},{"date":210,"type":38},"2023-10-23",{"date":212,"type":20},"2027-12",{"name":44,"class":45},4,{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":222,"sex":16,"minAge":78,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":225,"conditions":226,"keywords":228,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":70},"100582447","mymobility-knee-rom-100582447","NCT06863428","Mymobility Knee ROM","Concordance Between an App-based Range of Motion Measurement and Standard Goniometer.","Inclusion Criteria:\n\n* Patient is a minimum of 18 years of age\n* Patient is willing and able to provide written Informed Consent by signing and dating the IRB-approved Informed Consent form\n\nExclusion Criteria:\n\n* The patient is currently participating in any other study that would hinder the assessor's ability to measure knee ROM\n* Complex primary knee pathology with significant restrictions on the range of motion per surgeon discretion\n* Patient is pregnant or considered a member of a protected population (e.g. prisoner, mentally incompetent, etc.)",true,{"count":224,"type":20},41,"This prospective study aims to evaluate the agreement, also referred as concordance, of the mymobilty knee ROM with a clinician's assessment of knee ROM via goniometer.",[227],"Knee Range of Motion",[229,230,231],"mymobility","range of motion","goniometer","2026-01-15",{"date":234,"type":38},"2026-01-20",{"date":236,"type":38},"2025-11-21",{"date":238,"type":20},"2026-07-01",{"name":44,"class":45},{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":249,"conditions":250,"keywords":259,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":262,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":268},"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",{"count":248,"type":20},760,"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",[251,252,162,253,254,255,256,257,258],"Knee Pain Chronic","Osteoarthritis, Knee","Traumatic Arthritis","Polyarthritis","Varus Deformity","Valgus Deformity","Flexion Deformity of Knee","Avascular Necrosis",[260,261],"Osteoarthritis","Total Knee Arthroplasty",{"date":234,"type":38},{"date":264,"type":38},"2023-06-28",{"date":266,"type":20},"2035-06",{"name":44,"class":45},16,{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":4,"enrollmentInfo":276,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":278,"conditions":279,"keywords":281,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":70},"100569814","hi-fatigue-g-bone-cement-retrospective-study-100569814","NCT06699134","Hi-Fatigue G Bone Cement Retrospective Study","Evaluation of Hi-Fatigue G Bone Cement With Gentamicin A Retrospective Data Collection","Inclusion Criteria:\n\n* Subject qualified for cemented TKA or THA with a Zimmer Biomet implant\n* Subject is willing and able to give written informed consent for retrospective data collection and undergo interim and final evaluation (X-Ray \\& Scores completion)\n* Subject \\> 18 years old\n\nExclusion Criteria:\n\n* Muscle wasting\n* Neuromuscular compromise in the affected limb\n* Known hypersensitivity to any of the cement constituents\n* Subjects with severe renal failure\n* Bilateral interventions\n* Subject is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, known alcohol or drug abuser, anticipated to be non-compliant)",{"count":277,"type":20},90,"The objective of this retrospective monocentric study is to collect survivorship and clinical data confirming safety, performance and clinical benefits for the Hi-Fatigue G Bone Cement.\n\nThe assessments will include:\n\n* Radiological analysis performed at different time points according to the standard of care of the hospital\n* Implant survivorship and safety based on removal of a study device\n* Patient reported outcome measures (PROMs)\n\nPrimary endpoint:\n\nAssessment of radiolucent lines around the components (tibial, femoral, acetabular) at 5 years (in accordance with the hospital standard of care).\n\nSecondary endpoints:\n\n* Evaluation of implant survivorship and safety by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and\u002For procedure should be specified.\n* Evaluation of PROMs\n* Obtain information regarding the cementing technique and handling of the cement, if available",[280],"Total Hip and Knee Arthroplasties",[282,283,284],"Bone Cement","Knee Arthroplasty","Hip Arthroplasty","2025-12-01",{"date":287,"type":38},"2025-12-02",{"date":289,"type":38},"2024-11-19",{"date":291,"type":20},"2026-10",{"name":44,"class":45},{"id":294,"slug":295,"hasResults":11,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":4,"eligibilityCriteria":299,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":4,"enrollmentInfo":300,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":302,"conditions":303,"keywords":306,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":268},"100440989","zimmer-natural-nail-znn-bactiguard-tibia-post-market-clinical-follow-up-study-100440989","NCT05022485","Zimmer® Natural Nail® (ZNN) Bactiguard Tibia Post-Market Clinical Follow-up Study","Performance, Safety and Clinical Benefits of a Noble Metal Alloy-coated Intramedullary Nail: a Multicenter, Prospective Trial With a Retrospective Control","Inclusion Criteria:\n\n* Patient must be 18 or older.\n* Patient has signed IRB\u002FEC-approved informed consent (if applicable for retrospective controls, based on local requirements).\n* Patient suffered primary tibia fracture (monolateral or bilateral) at high risk of infection, eligible for fixation by intramedullary (IM) nailing (standard or suprapatellar approach) and meets at least one of the following conditions:\n\n  * Open fractures (incl. gunshot fractures): Gustilo Type I, II, III A and III B.\n  * Delayed treatment (initial treatment by external fixation due to swelling\u002F high energy trauma followed by definitive treatment by intramedullary nail).\n  * Fracture associated with ipsilateral leg compartment syndrome treated with fasciotomy wound(s).\n  * Closed fractures with severe tissue damage: Tscherne grade C2 and C3.\n* Patient:\n\n  * will be treated with ZNN Bactiguard tibia for inclusion in investigational group (retrospective enrollment is allowed up to 1st follow-up visit);\n  * was treated with uncoated (conventional) titanium-alloy intramedullary tibia nail for inclusion in control group;\n\nExclusion Criteria:\n\n* Patient is unwilling or unable to give consent.\n* Patient is not expected to survive follow-up schedule.\n* Patient is anticipated to be non-compliant to the study protocol.\n* Patient has a mental or neurological condition or alcohol\u002Fdrug addiction that will not allow for proper informed consent and\u002For participation in follow-up program.\n* Patient is a prisoner.\n* Patient is known to be pregnant and\u002For breastfeeding.\n* Patient suffered tibia fracture that meets any of the following conditions:\n\n  * Pathologic fracture.\n  * Gustilo Type IIIC open fracture.\n  * Patient has multisegmented fracture NOT eligible for fixation by intramedullary nailing.\n  * Patients with wound closure more than 10 days after injury.\n  * Besides IM nail, patient requires additional tibia fixation by plate (additional tibia fixation by screw(s) and\u002For fibula plate fixation are allowed).\n  * Concomitant with fracture, patient suffered head injury with Abbreviated Injury Score (AIS) ≥ 3.\n* For control group:\n\n  * patient doesn't have all the minimum required data available:\n\n    1. demographic information\n    2. injury classification\n    3. FRI information\n    4. operative report and device information\n    5. radiographic analyses (until fracture healing or confirmation of non-union leading to reoperation)\n* Tibia medullary canal is obliterated by a previous fracture or tumor\\*\n* Tibia bone shaft having excessive bow or a deformity\\*\n* Lack of bone substance or bone quality, which makes stable seating of the nail implant impossible\\*\n* All concomitant diseases that can impair the operation, functioning or the success of the nail implant\\*\n* Insufficient blood circulation\\*\n* Skeletally immature patients\\*\n* Infection\\*\n\n  * ZNN Bactiguard tibia contraindication",{"count":301,"type":20},500,"Primary objective of this study is to compare fracture related infection (FRI) rates of ZNN Bactiguard Tibia to conventional uncoated titanium-alloy nails 12 months after tibia fracture fixation.\n\nThe secondary objectives are confirmation of safety, performance and clinical benefits of ZNN Bactiguard implant and related instrumentation12 months after fracture fixation.",[304,305],"Tibial Fractures","Fracture Infection",[307,204],"intramedullary tibia nail","2025-11-20",{"date":310,"type":38},"2025-11-25",{"date":312,"type":38},"2022-04-11",{"date":314,"type":20},"2027-07",{"name":44,"class":45},{"id":317,"slug":318,"hasResults":11,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":4,"enrollmentInfo":323,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":325,"conditions":326,"keywords":328,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":70},"100466810","pmcf-study-on-the-safety-performance-and-clinical-benefits-data-of-the-anatomical-shoulder-bipolar-system-100466810","NCT05358574","PMCF Study on the Safety, Performance and Clinical Benefits Data of the Anatomical Shoulder Bipolar System","Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Anatomical Shoulderᵀᴹ Bipolar System (Implants and Instrumentation) - A Retrospective and Prospective Consecutive Series Study","Inclusion Criteria:\n\n1. The Anatomical Should Bipolar Adaptor is indicated for hemi shoulder replacement as a salvage solution in situations, where a Zimmer Anatomical Shoulder Inverse\u002FReverse prosthesis was originally planned, but it is intra-operatively found that the attachment of the Zimmer Anatomical Shoulder Inverse\u002FReverse glenoid fixation is not possible\n2. Patient should have received the Anatomical Shoulder Bipolar System\n3. Patient should have signed the Informed Consent Form\n4. Patient is 18-100 years of age, inclusive\n5. Patient is skeletally mature\n\nExclusion Criteria:\n\n1. Patients who are not willing to return for study required follow-up visits and\u002For are not willing to comply with the follow-up schedule\n2. Patients who have any condition which would in the judgement of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, or is a known drug abuser, a known alcoholic or anyone who cannot understand what is required of them\n3. Patient is known to be pregnant or breastfeeding\n4. Musculoskeletal situation that enables the application of a regular hemi or total shoulder system\n5. Good quantity or quality of the glenoid bone, where the fixation of a Zimmer Anatomical Shoulder Inverse\u002FReverse glenoid fixation is possible\n6. Patient's physical conditions that would impair achieving adequate implant support, and\u002For prevent the use of an appropriately sized implant (e.g. due to insufficient quality or quantity of bone).\n7. Signs of infection\n8. Non-functional deltoid muscle\n9. Charcot's shoulder (neuroarthropathy)\n10. Presence of significant injury to the upper brachial plexus\n11. Any neuromuscular or vascular disease compromising the affected limb that would endanger the success of the intervention",{"count":324,"type":20},40,"The study is a monocentric, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect long-term data confirming safety, performance and clinical benefits of the Anatomical Shoulder Bipolar System (Implants and Instrumentation) when used as a salvage solution in shoulder replacement.\n\nThe primary objective is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications and adverse events. Relation of the events to implant, instrumentation and\u002For procedure should be specified.\n\nThe secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcome measures (PROMs) as well as radiographic outcomes.",[327],"Revision of a Shoulder Prosthesis",[329,330,331,332,333],"Post-Market Clinical Follow-Up Study","Medical Device","Performance","Safety","Clinical Benefits","2025-11-19",{"date":310,"type":38},{"date":337,"type":38},"2022-04-22",{"date":339,"type":20},"2033-07-16",{"name":44,"class":45},{"id":342,"slug":343,"hasResults":11,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":349,"conditions":350,"keywords":353,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":355,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":359,"locationsCount":46},"100465333","znn-bactiguard-antegrade-femoral-nails-pmcf-study-100465333","NCT05339360","ZNN Bactiguard Antegrade Femoral Nails PMCF Study","Post-Market Clinical Follow-up Study on the ZNN™ Bactiguard ® Antegrade Femoral Nails (Implants and Instrumentation). A Multicenter, Prospective, Consecutive Series","Inclusion Criteria:\n\n* Patient must be 18 or older\n* Patient must have a signed EC-approved informed consent.\n* Patient must have a femoral fracture (open, closed, monolateral, or bilateral) requiring surgical intervention or osteotomy and be eligible for fixation by intramedullary nailing. Patients with delayed treatment (initial treatment by external fixation due to swelling\u002F high energy trauma followed by definitive treatment by intramedullary nail) can also be included.\n* Patient has been or is scheduled to be treated with the ZNN Bactiguard System Antegrade Femoral Nail\n* Patient must be able and willing to complete the protocol required for follow-up\n* Patients capable of understanding the surgeon's explanations and following his instructions\n\nExclusion Criteria:\n\nSkeletally immature patients\n\n* Medullary canal obliterated by a previous fracture or tumor\n* Bone shaft having excessive bow or a deformity\n* Lack of bone substance or bone quality, which makes stable seating of the implant impossible\n* All concomitant diseases that can impair the operation, functioning or the success of the implant\n* Insufficient blood circulation\n* Infection\n* Patient is unwilling to give consent.\n* Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, subjects with alcohol\u002Fdrug addiction, known to be pregnant or breast feeding)\n* Patient anticipated to be non-compliant and\u002For likely to have problems with maintaining follow-up program (e.g. patient with no fixed address, long-distance, plans to move during the course of study)\n* Patients not expected to survive the duration of the follow-up program",{"count":199,"type":20},"This is a multicenter, prospective, Post-market Clinical Follow-up (PMCF) Study on the ZNN Bactiguard Antegrade Femoral Nails. The objective of this study is to collect data confirming the safety, performance, and clinical benefit of the study device and instrumentation when used for the temporary internal fixation and stabilization of femoral fractures and osteotomies.\n\nThis is a CE-marked device already available on the market and the aim of the study is to comply with the post-market surveillance requirements.",[351,352],"Femur Fracture","Osteotomy",[354,204],"Intramedullary antegrade femoral nail",{"date":310,"type":38},{"date":357,"type":38},"2024-01-16",{"date":212,"type":20},{"name":44,"class":45},{"id":361,"slug":362,"hasResults":11,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":4,"eligibilityCriteria":366,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":4,"enrollmentInfo":367,"targetDuration":4,"studyType":99,"phases":369,"briefSummary":370,"conditions":371,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":382},"100380036","juggerstitch-post-market-clinical-follow-up-study-100380036","NCT04228367","JuggerStitch Post Market Clinical Follow-up Study","JuggerStitch™ for Meniscal Repair Post Market Clinical Follow-up Study","Inclusion Criteria:\n\n* Subject qualifies for meniscal repair based on the physical exam and medical history and meets the approved indications for use of the study product;\n* Older than 18 years and skeletally mature;\n* Willing and able to comply with the study procedures;\n* Subject is capable of understanding the doctor's explanations, following his instructions and is able to participate in the follow-up program;\n* Subject is able to read and understand the informed consent form (ICF) and has voluntarily provided written informed consent.\n\nExclusion Criteria:\n\n* Meniscal tears in the avascular zone of meniscus;\n* Meniscal tears not suitable for repair because of the degree of damage(marked irregularity and complex tearing) to the meniscus body including degenerative, radial, horizontal cleavage and flap tears;\n* Presence of active infection;\n* If female, subject is pregnant;\n* Subject is vulnerable (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant);\n* The subject is unwilling or unable to give consent or to comply with the follow-up program;\n* Subject meets any contraindications of the appropriate Instruction for Use.",{"count":368,"type":20},104,[101],"This study is a post-market follow-up study. The data collected from this study will serve the purpose of confirming the safety and performance of the JuggerStitch Device used for meniscal repair according to the product labelling (Instruction For Use).",[372,373],"Meniscus Tear, Tibial","Meniscus Lesion","2025-11-10",{"date":376,"type":38},"2025-11-12",{"date":378,"type":38},"2020-09-25",{"date":380,"type":20},"2026-04-30",{"name":44,"class":45},6,{"id":384,"slug":385,"hasResults":11,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":392,"conditions":393,"keywords":397,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":46},"100600960","z1-hip-system-post-market-clinical-follow-up-study-100600960","NCT07104279","Z1 Hip System: Post-Market Clinical Follow Up Study","Multicenter, Post-Market Clinical Follow-up Study of the Z1 Femoral Hip System","Inclusion Criteria:\n\n* Patient is at least 18 years old and skeletally mature\n* Patient is physically and mentally willing and able, in the Investigator's opinion at the time of enrollment, to be compliant with the protocol, including all scheduled study evaluations\n* Patient, or the patient's legally authorized representative, is willing and able to participate in the Informed Consent process and provide their consent\n* Independent of study participation, patient is a candidate and qualifies for primary total hip or hemi-arthroplasty based on physical exam and medical history including at least one of the following:\n\n  * Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases\n  * Acute traumatic fracture of the femoral head or neck\n  * Avascular necrosis (AVN) of the femoral head\n\nExclusion Criteria:\n\n* Revision arthroplasty\n* Acute, chronic, local, or systemic infection(s)\n* Severe muscular, neural, or vascular diseases that endanger the limb(s) involved\n* Lack of bony structures proximal or distal to the joint, so that good anchorage of the implant is unlikely or impossible\n* Total or partial absence of the muscular or ligamentous apparatus\n* Any concomitant diseases that can jeopardize the functioning and the success of the implant\n* Allergy to the implanted material, especially to metal (e.g. cobalt, chromium, nickel, etc.)\n* Local bone tumors and\u002For cysts\n* Patient has any condition that would, in the Investigator's opinion, place the patient at undue risk or interfere with the study\n* Any vulnerable subject:\n\n  * a prisoner\n  * a patient known to be pregnant\n  * mentally incompetent or unable to understand what participation in the study entails\n  * a known substance abuser",{"count":391,"type":20},150,"The objectives of this study are to confirm the early to mid-term safety, performance, and clinical benefits of the Z1 Femoral Hip System in hemi-hip arthroplasty and primary total hip arthroplasty.\n\nThe primary objective of this post market clinical follow-up (PMCF) study is the assessment of safety by recording and analyzing the survival of the implant system at 2 years post-implantation. Safety will also be established by recording the incidence and frequency of revisions, complications, and adverse events. Relation of the events to implant, instrumentation, and\u002For procedure should be specified.\n\nThe secondary objective is the assessment of functional performance and clinical benefits of the Z1 Femoral Hip System demonstrated by recording patient-reported clinical outcomes measures (PROMs).",[394,395,396],"Hip Osteoarthritis","Acute Traumatic Fracture of the Femoral Head or Neck","Avascular Necrosis of the Femoral Head",[398,399,400,401,402],"total hip arthroplasty","total hip replacement","osteoarthritis","hemiarthroplasty","partial hip replacement","2025-11-06",{"date":374,"type":38},{"date":406,"type":38},"2025-10-13",{"date":408,"type":20},"2031-08",{"name":44,"class":45},{"id":411,"slug":412,"hasResults":11,"nctId":413,"briefTitle":414,"officialTitle":415,"acronym":4,"eligibilityCriteria":416,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":4,"enrollmentInfo":417,"targetDuration":4,"studyType":99,"phases":419,"briefSummary":420,"conditions":421,"keywords":432,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":452},"100245148","clinical-outcomes-study-of-the-nexel-total-elbow-100245148","NCT02469662","Clinical Outcomes Study of the Nexel Total Elbow","Retrospective and Prospective Clinical Outcomes Study of the Zimmer® Nexel™ Total Elbow","Inclusion Criteria:\n\n* Patient is 18 years of age or older.\n* Patient must have signed Institutional Review Board (IRB)\u002FEthics Committee (EC)-approved informed consent.\n* Patient is a candidate for primary or revision total elbow arthroplasty, based on symptoms including at least one of the following:\n\n  * Elbow joint destruction which significantly compromises daily living activities\n  * Post-traumatic lesions or bone loss contributing to elbow instability\n  * Ankylosed joints, especially cases of bilateral ankylosis from causes other than active sepsis\n  * Advanced rheumatoid arthritis, post-traumatic, or degenerative arthritis with incapacitating pain\n  * Instability or loss of motion when the degree of joint or soft tissue damage precludes reliable osteosynthesis\n  * Acute comminuted articular fracture of elbow joint surfaces that precludes less radical procedures, including 13-C3 fractures of the distal humerus\n* Patient is willing and able to complete scheduled follow-up evaluations as defined by the protocol.\n\nAdditional Retrospective Arm Inclusion Criteria\n\n* Patient must have undergone a total elbow replacement with the Nexel system between July 2013 and the date of the site initiation visit.\n* Patient information available for each retrospective patient must, at minimum, include preoperative demographic information, preoperative physical exam information, the index surgery operative report, and details of the devices implanted.\n\nExclusion Criteria:\n\n* Patient has a currently active or history of repeated local infection at the surgical site.\n* Patient has a current major infection distant from the operative site.\n* Patient has a history of prior sepsis.\n* Patient suffers from paralysis or dysfunctional neuropathy at the elbow joint.\n* Patient has significant ipsilateral hand dysfunction.\n* Patient has excessive scarring near the surgical site, which could prevent adequate soft tissue coverage.\n* Patient participates in daily activities that may cause significant stress to an implanted device such as heavy labor, torsional stress, and\u002For competitive sports.\n* Patient is a prisoner.\n* Patient is mentally incompetent or unable to understand what participation in the study entails.\n* Patient is a known alcohol or drug abuser.\n* Patient is anticipated to be non-compliant.\n* Patient is known to be pregnant.",{"count":418,"type":20},134,[101],"The objectives of the study are to confirm safety and performance of the Zimmer Nexel Total Elbow when used in primary or revision total elbow replacement.",[422,423,424,425,426,427,428,429,430,431],"Elbow Joint Destruction","Post-traumatic Lesions","Ankylosed Joints","Advanced Rheumatoid Arthritis","Joint Instability or Loss of Motion","Acute Comminuted Articular Fracture of Elbow Joint Surfaces","Bone Loss Contributing to Elbow Instability","Bilateral Ankylosis From Causes Other Than Active Sepsis","Post-traumatic Arthritis","Degenerative Arthritis",[433,434,435,436,425,437,431,422,438,424,439,440,441,442,443],"Total Elbow Arthroplasty","TEA","Elbow Arthroplasty","Elbow Replacement","Post-Traumatic Arthritis","Post-Traumatic Lesions or Bone Loss","Acute Comminuted Articular Fracture","Significantly compromises daily living activities","Joint or soft tissue damage","Precludes less radical procedures","13-C3 fractures of the distal humerus","2025-10-28",{"date":446,"type":38},"2025-10-29",{"date":448,"type":38},"2015-06",{"date":450,"type":20},"2036-12",{"name":44,"class":45},11,{"id":454,"slug":455,"hasResults":11,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":4,"eligibilityCriteria":459,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":4,"enrollmentInfo":460,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":462,"conditions":463,"keywords":468,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":268},"100425529","persona-revision-knee-system-outcomes-100425529","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.",{"count":461,"type":20},380,"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.",[464,465,466,467],"Arthroplasty Complications","Infection","Knee Disease","Knee Osteoarthritis",[469,470,330,332,331,471,333],"Revision","Total Knee","Primary","2025-10-22",{"date":474,"type":38},"2025-10-24",{"date":476,"type":38},"2021-06-14",{"date":478,"type":20},"2027-12-31",{"name":44,"class":45},{"id":481,"slug":482,"hasResults":11,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":4,"eligibilityCriteria":486,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":4,"enrollmentInfo":487,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":489,"conditions":490,"keywords":494,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":70},"100466237","pmcf-study-on-the-safety-performance-and-clinical-benefits-data-of-the-anatomical-shoulder-20-fracture-system-100466237","NCT05351112","PMCF Study on the Safety, Performance and Clinical Benefits Data of the Anatomical Shoulder 2.0 Fracture System","Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Anatomical Shoulderᵀᴹ 2.0 Fracture System (Implants and Instrumentation) - A Retrospective and Prospective Consecutive Series Study","Inclusion Criteria:\n\n* Patients 18 years or older and skeletally mature\n* Patients capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study\n* Replacement of the proximal humerus and the glenoid articular surface of the scapula during total-, hemi- and fracture shoulder arthroplasty in treatment of the following:\n\n  1. Complex 3- and 4- part fractures of the proximal humerus with subluxation of the head fragment\n  2. Complex 3- and 4- part fractures of the proximal humerus with loosening of the spongiosa in the head fragment\n  3. Complex 3- and 4- part fractures of the proximal humerus with additional cross split of the head fragment\n  4. Fracture instability after osteosynthesis of 3- and 4-part fracture fragments of the proximal humerus\n  5. Posttraumatic necrosis of the humeral head\n  6. Posttraumatic arthrosis after humeral head fracture\n\nExclusion Criteria:\n\n* Patients who are unwilling or unable to give consent, not willing to return for study required follow-up visits and\u002For to comply with the follow-up program.\n* The patient is known to be pregnant or breastfeeding\n* Patients who have any condition that would in the judgment of the Investigator place the patient at undue risk or interfere with the study.\n* Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant).\n* Patients with plans to relocate during the study follow-up period\n* Signs of infection\n* Extensive stiffening of the shoulder joint without pain",{"count":488,"type":20},78,"The study is a multicenter, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect long-term data confirming safety, performance and clinical benefits of the Anatomical Shoulder 2.0 Fracture System (Implants and Instrumentation) when used for fracture shoulder arthroplasty. The primary objective is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications and adverse events. Relation of the events to implant, instrumentation and\u002For procedure should be specified.\n\nThe secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcome measures (PROMs) as well as radiographic outcomes.",[491,492,493],"Proximal Humerus Fracture","Posttraumatic Arthrosis After Humeral Head Fracture","Posttraumatic Necrosis of the Humeral Head",[329,330,331,332,333],"2025-08-12",{"date":497,"type":38},"2025-08-17",{"date":499,"type":38},"2022-07-07",{"date":501,"type":20},"2034-01-21",{"name":44,"class":45},{"id":504,"slug":505,"hasResults":11,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":4,"eligibilityCriteria":509,"healthyVolunteers":222,"sex":16,"minAge":78,"maxAge":4,"enrollmentInfo":510,"targetDuration":4,"studyType":99,"phases":512,"briefSummary":513,"conditions":514,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":452},"100420387","g7-acetabular-system-with-vivacit-e-or-longevity-liner-pmcf-study-100420387","NCT04754087","G7 Acetabular System With Vivacit-E or Longevity Liner PMCF Study","Global, Multicenter, and Prospective Post-Market Clinical Follow-Up Study of the G7 Acetabular System With Vivacit-E and Longevity Highly Crosslinked Polyethylene (HXLPE) Liners & Instrumentation","Inclusion Criteria:\n\n* Patient must be a legal adult who has reached full skeletal maturity.\n* Patient must be treated for one of the following indications:\n* Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis\n* Rheumatoid arthritis\n* Correction of functional deformity\n* Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques\n* Revision procedures where other treatment or devices have failed\n* Patient must be able and willing to complete the protocol required follow-up visits.\n* Patient must be able and willing to sign the Institutional Review Board or Ethics Committee (IRB\u002FEC) approved informed consent.\n\nExclusion Criteria:\n\n* Patient presents with osteoporosis, which in the opinion of the Principal Investigator, may limit the subject's ability to support total hip arthroplasty using the study device.\n* Patient has a metabolic disorder that may impair bone formation.\n* Patient has osteomalacia.\n* Patient has distant foci of infections which may spread to the implant site or patient with infection, sepsis or osteomyelitis.\n* Patient has rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.\n* Patient has a vascular insufficiency, muscular atrophy, or neuromuscular disease\n* Patient is a prisoner.\n* Patient is a current alcohol or drug abuser.\n* Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.\n* Patient is pregnant.",{"count":511,"type":20},300,[101],"The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Acetabular Shells when used with the Vivacit-E and Longevity HXLPE liners and instrumentation in primary and revision total hip arthroplasty.",[515,516,517,518,519,520,521,522],"Total Hip Arthroplasty","Degenerative Joint Disease of Hip","Avascular Necrosis of Hip","Rheumatoid Arthritis of Hip","Osteoarthritis, Hip","Osteoarthritis of Hip","Fractures, Hip","Fracture of Hip","2025-06-13",{"date":525,"type":38},"2025-06-18",{"date":527,"type":38},"2021-07-07",{"date":529,"type":20},"2033-12-31",{"name":44,"class":45},{"id":532,"slug":533,"hasResults":11,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":4,"eligibilityCriteria":537,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":4,"enrollmentInfo":538,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":540,"conditions":541,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":548,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":554,"locationsCount":555},"100364703","mdr---pmcf-study-for-taperloc-complete-stems-100364703","NCT04028687","MDR - PMCF Study for Taperloc Complete Stems","Post Market Clinical Follow up Study to Provide Safety, Performance and Clinical Benefits Data of the Taperloc Complete Stems","Inclusion Criteria:\n\n* Patient must be 18 years of age or older and skeletally mature\n* Patient must be willing and able to sign IRB approved informed consent\n* Patient must have undergone primary or revision hip arthroplasty with the -Taperloc Complete stem according to a cleared indication, which includes the following:\n* Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis\n* Rheumatoid arthritis\n* Correction of functional deformity\n* Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques\n\nExclusion Criteria:\n\n* Off-label use\n* Infection\n* Sepsis\n* Osteomyelitis\n* Uncooperative patient or patient with neurologic disorders who are incapable of following directions\n* Osteoporosis\n* Metabolic disorders which may impair bone formation\n* Osteomalacia\n* Distant foci of infections which may spread to the implant site\n* Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram\n* Vascular insufficiency, muscular atrophy, or neuromuscular disease\n* Patient is known to be pregnant or nursing\n* Patient is a prisoner\n* Patient is a known alcohol or drug abuser\n* Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent",{"count":539,"type":20},820,"The objective of this consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Taperloc Complete stems when used for primary or revision total hip arthroplasty (implants) at 1,3,5,7 and 10-year follow-up\\*. Since Taperloc Complete was introduced to the EU in 2010, all available retrospective data will be collected from each patient and a prospective aspect to the study will be necessary to reach the 10-year time point.",[542,543,544,545,546],"Hip Arthritis","Hip Disease","Hip Fractures","Hip Injuries","Hip Pain Chronic","2025-03-10",{"date":549,"type":38},"2025-03-11",{"date":551,"type":38},"2020-02-13",{"date":553,"type":20},"2032-02-12",{"name":44,"class":45},3,{"id":557,"slug":558,"hasResults":11,"nctId":559,"briefTitle":560,"officialTitle":561,"acronym":4,"eligibilityCriteria":562,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":4,"enrollmentInfo":563,"targetDuration":4,"studyType":99,"phases":565,"briefSummary":566,"conditions":567,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":577,"locationsCount":70},"100518582","denct-shoulder-bone-quality-evaluation-100518582","NCT06032416","DenCT Shoulder Bone Quality Evaluation","Collection of CT Images to Evaluate Bone Quality Before Total Shoulder Arthroplasty","Inclusion Criteria:\n\n* Patient must be older than 18 years and skeletally mature.\n* Patient must undergo the SHA, TSA, or RSA according to the Instructions for Use (IFU).\n* Patient must be anatomically and structurally suited to receive shoulder arthroplasty implants.\n* Patient is a candidate for lateral or bi-lateral shoulder arthroplasty due to one or more of the following:\n* Non-inflammatory degenerative joint disease including osteoarthritis.\n* Avascular necrosis of the humeral head.\n* Autoimmune disease including rheumatoid arthritis.\n* Irreparable rotator cuff tears.\n* Correction of functional deformity.\n* Patient must be able and willing to sign the IRB\u002FEC approved informed consent.\n* Patient must be able to undergo a preoperative CT scan\n* Patient must be willing to share their CT images with sponsor\n\nExclusion Criteria:\n\n* Patient is a candidate for shoulder arthroplasty due to one or more of the following:\n* Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.\n* Revision TSA\u002FRSA after the prior TSA\u002FRSA.\n* Patient has experienced the traumatic fractures to the implant site.\n* Patient is unwilling or unable to give consent\n* Patient has any condition which would in the judgement of the Investigator, place the patient at undue risk or interfere with the study, e.g., any neuromuscular disease compromising the affected limb.\n* Patient is known to be pregnant or breastfeeding.\n* Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, and\u002For anticipated to be non- compliant).\n* Patient is uncooperative or patient with neurologic disorders who is incapable or unwilling to follow directions.\n* Patient has any sign of infection affecting the shoulder joint or in its proximity which may spread to the implant site.\n* Patient has rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram.",{"count":564,"type":20},200,[101],"The objective of the study is to evaluate the preoperative bone quality assessment based on CT to later establish a scale for the decision of stemless shoulder arthroplasty.",[568,569],"Osteoarthritis Shoulder","Rotator Cuff Tears","2025-02-07",{"date":572,"type":38},"2025-02-10",{"date":574,"type":20},"2025-04",{"date":576,"type":20},"2027-04",{"name":44,"class":45},{"id":579,"slug":580,"hasResults":11,"nctId":581,"briefTitle":582,"officialTitle":583,"acronym":4,"eligibilityCriteria":584,"healthyVolunteers":222,"sex":16,"minAge":78,"maxAge":4,"enrollmentInfo":585,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":587,"conditions":588,"keywords":590,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":592,"lastUpdatePostDateStruct":593,"startDateStruct":595,"completionDateStruct":597,"leadSponsor":599,"locationsCount":600},"100450553","ribfix-blu-thoracic-fixation-system-versus-non-surgical-treatment-in-non-flail-chest-rib-fractures-100450553","NCT05146986","RibFix Blu Thoracic Fixation System Versus Non-surgical Treatment in Non-flail Chest Rib Fractures","Prospective Multi-center Comparative Study of RibFix Blu Thoracic Fixation System Versus Non-surgical Treatment in Non-flail Chest Rib Fractures","Inclusion Criteria:\n\n* Age 18 and above (inclusive)\n* Simple rib fracture with ≥ 3 consecutive ribs, and the broken ends showed clear displacements\n* Indicated for surgical repair of rib fractures using RibFix Blu Thoracic Fixation System or non-surgical treatment (analgesia and symptomatic management treatment)\n* Willing and able to complete scheduled follow-up evaluations as described in the study protocol\n* Has participated in the Informed Consent process and is willing and able to sign an Institutional Review Board or Ethics Committee (IRB\u002FEC) approved Patient Information\u002F Informed consent Form (PICF)\n\nExclusion Criteria:\n\n* Flail chest rib fractures based on radiological or clinical findings\n* Previous rib fractures or pulmonary problems, requiring continuous oxygen use at home pre-trauma\n* Presence of any serious medical issues that placed patient in generally poor conditions such that he or she could not tolerate the surgery\n* Chest trauma associated with severe craniocerebral injury, abdominal organ injury, severe spinal injury, limb fracture, or pelvic fracture requiring long-term bed rest\n* Has serious medical disease that is a contraindication for general anesthesia, such as cerebral infarction, myocardial infarction and hemorrhagic syndrome\n* Any contraindications listed in the manufacturer's Instruction to use for RibFix Blu Thoracic Fixation System as per below:\n\n  * Spanning a midline sternotomy\n  * Active Infection\n  * Foreign body sensitivity\n* Is known to be pregnant\n* Is a prisoner, known alcohol or drug user or mentally incompetent or unable to understand what participation in this study entails.\n* Participation in another surgical intervention that may influence any of the outcome parameters.",{"count":586,"type":20},167,"This is a prospective, multi-center, observational, cohort study involving skilled cardiothoracic surgeons who are experienced in implanting the treatment of non-flail chest rib fractures and the use of RibFix Blu Thoracic Fixation System.",[589],"Rib; Fracture",[591],"Non-flail chest","2024-03-05",{"date":594,"type":38},"2024-03-07",{"date":596,"type":38},"2022-01-02",{"date":598,"type":20},"2026-12-30",{"name":44,"class":45},5,""]