[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Smith & Nephew, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":214},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,47,77,103,131,158,189],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100581959","evaluation-of-outcomes-following-rotator-cuff-repair-using-the-regeneten-bioinductive-implant-100581959",false,"NCT06857084","Evaluation Of Outcomes Following Rotator Cuff Repair Using the REGENETEN Bioinductive Implant","Evaluation Of Clinical and Health Economic Outcomes Following Rotator Cuff Repair Using the REGENETEN◊ Bioinductive Implant: A Prospective, Multi-Center Global Registry","RePaRe","Inclusion Criteria:\n\n* Subject requires Arthroscopic rotator cuff repair (ARCR);\n* Patients aged over 18 years old at the time of consent and providing baseline data before undergoing rotator cuff repair surgery (either partial or full thickness tears) will be eligible for this prospective registry.\n\nExclusion Criteria:\n\n* Subject who, in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the registry including mental illness, intellectual disability, and drug or alcohol abuse.\n* Subjects who do not meet the indication or are contraindicated according to specific Smith+Nephew REGENETEN System's Instructions for Use (IFUs);\n* Subject that meets the definition of a Vulnerable Subject per ISO14155:2020 Section 3.44.","ALL","18 Years",{"count":20,"type":21},400,"ESTIMATED","7 Years","OBSERVATIONAL","This prospective, single-arm, multicenter registry is being conducted to collect real world post-market data from patients who are undergoing rotator cuff repair using the REGENETEN◊ Bioinductive Implant System. The Registry will include up to 50 centers in the United Kingdom (UK), Europe, Australia, and up to 400 patients for the initial evaluation.\n\nPatients will be treated and evaluated according to standard medical care. Outcome data is collected up to 2 years post-surgery.",[26],"Rotator Cuff Injuries",[28,29,30,31,32,33],"Rotator Cuff Repair","Rotator Cuff Tear","Full Thickness Tear","Partial Thickness Tear","Massive Tear","REGENETEN Bioinductive Implant","RECRUITING","2026-05-28",{"date":37,"type":38},"2026-06-01","ACTUAL",{"date":40,"type":38},"2020-10-01",{"date":42,"type":21},"2029-12-31",{"name":44,"class":45},"Smith & Nephew, Inc.","INDUSTRY",22,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100427660","study-to-evaluate-the-safety-and-effectiveness-of-the-real-intelligence-cori-in-total-knee-arthroplasty-tka-procedure-100427660","NCT04848896","Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure","A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure","CORI RCT TKA","Inclusion Criteria:\n\n1. Subject is a suitable candidate for a TKA procedure using CORI and a corresponding S+N Knee Implant System.\n2. Subject requires a cemented TKA as a primary indication that meets any of the following condition:\n\n   * Non-inflammatory degenerative joint disease, including osteoarthritis\n   * Rheumatoid arthritis\n   * Avascular necrosis\n   * Requires correction of functional deformity\n   * Requires treatment of fractures that were unmanageable using other techniques\n3. Subject is of legal age to consent and considered skeletally mature (≥ 18 years of age at the time of surgery)\n4. Subject agrees to consent to and to follow the study visit schedule (as defined in the study protocol and informed consent form), by signing the Ethical Committee (EC) or Institutional Review Board (IRB) approved informed consent form.\n5. Subject plans to be available through two (2) year postoperative follow-up.\n6. Applicable routine radiographic assessment is possible.\n\nExclusion Criteria:\n\n1. Subject requires a TKA on the index joint as a revision for a previously failed surgery, or has the need for complex implants, or any other implant than a standard TKA (e.g. stems, augments, or custom-made devices).\n2. Subject has been diagnosed with post-traumatic arthritis.\n3. Subject receives simultaneous bilateral UKA OR a unilateral UKA with contralateral TKA.\n4. Subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the investigator:-Contralateral primary TKA or UKA, however, the subject can only have one knee enrolled in this study.\n5. Subject does not understand the language used in the Informed Consent Form.\n6. Subject does not meet the indication or is contraindicated for TKA according to the specific Smith+Nephew Knee System's Instructions For Use (IFU).\n7. Subject has active infection or sepsis (treated or untreated).\n8. Subject is morbidly obese with a body mass index (BMI) greater than 40.\n9. Subject is pregnant or breast feeding at the time of surgery.\n10. Subject, in the opinion of the Investigator, has advanced osteoarthritis or joint disease at the time of surgery and was better suited for an alternate procedure.\n11. Subject currently enrolled in another orthopedic clinical trial study.\n12. Subject has a condition(s) that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease, or an active, local infection).\n13. Subject in the opinion of the Investigator has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, intellectual disability, drug or alcohol abuse.\n14. Subject, in the opinion of the Investigator, has a neuromuscular disorder that prohibited control of the index joint.\n15. Subject is a prisoner or meets the definition of a Vulnerable Subject per International Organization for Standardization (ISO) 14155:2020 Section 3.55.",{"count":56,"type":21},140,"INTERVENTIONAL",[59],"NA","Background:\n\nREAL INTELLIGENCE™ CORI™ (CORI Robotics) is a computer-assisted orthopaedic surgical navigation and burring system. CORI Robotics is designed to help surgeons in planning and executing certain types of knee surgery involving bone preparation. These types of surgery are called 'unicondylar knee arthroplasty' (UKA) and 'total knee arthroplasty' (TKA).\n\nPurpose:\n\nThis study is being carried out to demonstrate the safety and effectiveness of the CORI Robotics in TKA procedure. The data collected will be used to demonstrate the safety and effectiveness of CORI and to register CORI in China mainland. The primary objective of this study is to evaluate the use of CORI in TKA procedure in achieving post-operative leg alignment as compared to procedures using conventional manual instruments.\n\nResearch participants \u002F locations:\n\n140 research participants will be recruited from up to 8 sites in 3 countries globally (Australia, China Mainland, Hong Kong and New Zealand). There will be 70 patients having TKA using CORI and 70 patients having TKA using conventional procedure.",[62,63,64],"Arthroplasty","Replacement","Knee",[66,67],"Osteoarthritis","Total Knee Arthroplasty (TKA)","2026-03-09",{"date":70,"type":38},"2026-03-11",{"date":72,"type":38},"2022-02-12",{"date":74,"type":21},"2028-03-31",{"name":44,"class":45},4,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":57,"phases":87,"briefSummary":88,"conditions":89,"keywords":90,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},"100473405","use-of-the-regeneten-bioinductive-implant-system-in-high-grade-partial-thickness-tears-100473405","NCT05444465","Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears","Evaluation of Safety and Efficacy of a Resorbable Collagen Implant in Treatment of High Grade PArtial ThiCkness Tears; A Prospective, Multicenter, Randomized, Control Trial (IMPACT Study)","IMPACT","Inclusion Criteria:\n\n* The subject must provide written informed consent.\n* Subject is \\> eighteen (18) years of age (no upper limit).\n* Subject has an isolated high-grade (\\>50% or \\>6mm) (Ellman grade III) partial thickness tear of supraspinatus or supraspinatus with infraspinatus.\n* Subject has failed a minimum of 3 months of conservative management for treatment of partial thickness rotator cuff tear.\n* Subject willing and able to make all required study visits.\n* Subject able to follow instructions and deemed capable of completing all study questionnaires.\n\nExclusion Criteria:\n\n* Subjects with insufficient tendon tissue quality for management and protection of the tendon injury using the isolated REGENETEN Bioinductive Implant system.\n* Subjects where the prescribed Physical Therapy guidelines stated in the protocol are not suitable for their rehabilitation.\n* Subjects with Samilson-Prieto osteoarthritis grade 2 and greater.\n* Subjects with current or prior infection of the ipsilateral shoulder.\n* Subjects with known hypersensitivity to bovine-derived materials.\n* Subjects with known inflammatory arthropathy, history of inflammatory arthropathy, chronic joint disease or chronic pain of upper extremities (shoulder(s), arm(s)).\n* Subjects with prior shoulder surgery on index shoulder, including subacromial decompression, biceps tenodesis\u002Ftenotomy, and acromioclavicular joint (ACJ) excision\u002Fdistal clavicle excision (DCE).\n* Subjects with a planned surgery on the contra-lateral shoulder within the study period.\n* Systemic steroid use (oral, IV) or local steroid injection within 3 months of the date of surgery.\n* Subjects with a full thickness rotator cuff tear.\n* Subjects with a subscapularis tear requiring repair.\n* Subjects requiring a concomitant labral fixation procedure, concomitant surgery for bone defects requiring bone implantation or for superior labral tear from anterior to posterior (SLAP).\n* Subjects requiring a concomitant os acromiale fixation procedure.\n* Subjects with glenohumeral joint instability (multiple dislocations\u002Fsubluxations).\n* Subjects with condition(s) that contraindicate or complicate outcomes of Isolated Bioinductive Repair or completion and repair e.g., \\> Hamada 3 rotator cuff arthropathy on X-ray, Goutallier atrophy \\> Grade 3, proximal humeral fracture or scapular fracture, avascular necrosis of the humeral head.\n* Subjects with neurologic conditions effecting either upper extremity.\n* Subjects who are unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications.\n* Subjects who are pregnant or breast feeding.\n* Subjects who are currently involved in any injury litigation relating to the index shoulder.\n* Subjects with current workers compensation claim.\n* Subjects who are enrolled, or plan to enroll, in another clinical trial during this study that would affect the outcomes of this study.\n* Subjects with a history of poor compliance with medical treatment, physical therapy (PT)\u002Frehabilitation, or clinical study participation.\n* Subject who, in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, and drug or alcohol abuse.\n* Subjects who do not meet the indication or are contraindicated according to specific Smith+Nephew REGENETEN System's Instructions for Use (IFUs).\n* Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55.\n* Subjects who have participated previously in this clinical trial and who have healed or been withdrawn\n* Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.",{"count":86,"type":21},234,[59],"The purpose of the study is to assess whether the REGENETEN™ Bioinductive Implant allows patients to get back to their everyday activities quicker than if the tendon is repaired by the standard repair technique 'Completion and Repair' for surgically treating partial-thickness rotator cuff tears.",[26],[91,92,93],"Rotator cuff tear","High grade partial thickness tears","REGENETEN Bioinductive Implant System","2026-01-14",{"date":96,"type":38},"2026-01-15",{"date":98,"type":38},"2022-08-30",{"date":100,"type":21},"2028-06-30",{"name":44,"class":45},20,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":57,"phases":113,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":129,"locationsCount":130},"100594888","post-market-clinical-study-to-evaluate-the-safety-and-effectiveness-of-reflex-ultra-45-for-coblation-inferior-turbinate-reduction-in-china-100594888","NCT07025304","Post-Market Clinical Study to Evaluate the Safety and Effectiveness of REFLEX ULTRA 45 for Coblation Inferior Turbinate Reduction in China","A Prospective, Multi-center, Post-Market Clinical Study to Evaluate the Safety and Effectiveness of the REFLEX ULTRA 45 for the Coblation Inferior Turbinate Reduction in China","Inclusion Criteria:\n\n* Subject with at least two-year history of perennial rhinitis and who has failed one month of continuous standardized treatment with hormonal nasal spray by the date of surgery.\n* Subject with nasal obstruction due to turbinate hypertrophy and is suitable to receive coblation inferior turbinate reduction for bilateral nasal cavity without outfracture of inferior turbinate per the investigator's judgement.\n* Subject is 18 - 65 years old (inclusive).\n* Subject provides written informed consent for study participation using an Independent Ethical Committee (IEC) approved consent form before any study procedures are performed, including pre- operative data review and\u002For collection of data on electronic Case Report Forms (eCRFs).\n* Subject is willing and able to participate in required follow-up visits and is able to complete study activities.\n\nExclusion Criteria:\n\n* Subject who does not meet the indication or is contraindicated according to specific REFLEX ULTRA 45 's Instructions for Use (IFUs).\n* Subject with obvious deviation of nasal septum with the necessity of surgery under investigator's judgement.\n* Participation in the treatment period of another clinical trial within thirty (30) days of all visits completed.\n* Subject who needs other nasal surgery other than single inferior turbinate reduction evaluated by MRI and nasal endoscopy.\n* Subject who has nasal obstruction due to inferior turbinate bony hypertrophy.\n* Subject who was treated with inferior turbinate reduction before informed consent.\n* Subjects who completed the Zung Self-Rating Anxiety Scale and the anxiety rate is more than 59.\n* Woman who is pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures.\n* Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55.\n* Subject who has participated previously in this clinical trial or who has been withdrawn.\n* Subject with a history of poor compliance with medical treatment.\n* Subject with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.","65 Years",{"count":112,"type":21},105,[59],"The study is a prospective, multi-center, post-market clinical study to evaluate the safety and effectiveness of REFLEX ULTRA 45 for the coblation inferior turbinate reduction in China. The study product is REFLEX ULTRA 45 (EIC4845-01\u002FEICA4845-01). Also it needs to be performed with the controller system COBLATOR II or WEREWOLF. The sample size is 105 subjects with approximate 6 sites in China mainland.",[116],"Nasal Obstruction Due to Inferior Turbinate Hypertrophy",[118,119,120,121,122],"REFLEX","CITR","ITH","Coblation Inferior Turbinate Reduction","Inferior Turbinate Hypertrophy","2026-01-05",{"date":125,"type":38},"2026-01-07",{"date":127,"type":38},"2025-07-02",{"date":100,"type":21},{"name":44,"class":45},6,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":140,"conditions":141,"keywords":145,"overallStatus":149,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":130},"100608298","a-multi-center-study-assessing-the-safety-and-efficacy-of-the-legion-medial-stabilized-ms-insert-in-patients-undergoing-a-total-knee-arthroplasty-tka-100608298","NCT07199738","A Multi-Center Study Assessing the Safety and Efficacy of the LEGION Medial Stabilized (MS) Insert in Patients Undergoing a Total Knee Arthroplasty (TKA)","Inclusion Criteria:\n\n1. A). Prospective Subjects: Subject needing primary Total Knee Arthroplasty (TKA) due to degenerative joint disease (primary diagnosis of osteoarthritis), post-traumatic arthritis or inflammatory arthritis.\n\n   OR\n\n   B). Retro-prospective Subjects: Subject has undergone primary TKA using the investigational product in the past 12 months to repair degenerative joint disease, post-traumatic arthritis or inflammatory arthritis and all the following conditions have been met:\n   * Pre-operative Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) has been obtained\n   * Post-operative radiographs have been obtained, or these can be collected prospectively in window per schedule of events\n   * 12-month post-operative KOOS JR have been obtained, or these can be collected prospectively in window per schedule of events\n2. Subject's treating clinician has decided the study device is suitable for the subjects TKA procedure and the study device is used in line with the applicable Instructions For Use (IFU) (listed in section 6).\n3. Subject agrees to consent and follow the prospective study visit schedule up to 10 years post-surgery (as defined in the study protocol and informed consent form) by signing the Independent Review Board (IRB)\u002FIndependent Ethics Committee (IEC) approved consent form.\n4. Subject is able to read, understand and communicate responses to Patient Reported Outcome Measure (PROM).\n5. Subject is 18-80 years old at the time of consent (inclusive).\n\nExclusion Criteria:\n\n1. Subject received revision TKA on the contralateral knee for a previously failed TKA, or Unicondylar Knee Arthroplasty (UKA).\n2. Subject has a Body Mass Index (BMI) ≥ 40 at pre-operative visit.\n3. Subject has ipsilateral hip arthritis resulting in flexion contracture of the hip joint.\n4. At the time of surgery, subject has one or more of the following arthroplasties that are not fully healed and\u002For well-functioning, in the opinion of the Investigator: Ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty; contralateral primary TKA or UKA.\n5. Subject has a condition that may interfere with the TKA survival or outcome (e.g., Paget's or Charcot's disease, vascular insufficiency, lupus, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease).\n6. Subject has a known allergy to one or more of the components of the study device.\n7. Any subject with hardware present in ipsilateral distal femur or proximal tibia.\n8. Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55.\n9. Subject is entered in another drug, biologic, or device study or has been treated with an investigational product in the past 30 days (30 days from operation\u002Fdosing).\n10. Subject, in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study, ability to consent or complete the PROMs, including mental illness, drug or alcohol abuse.\n11. In the opinion of the Investigator, or site staff, Subject is at risk for lost to follow-up, or failure to return for scheduled visits.\n12. Women who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures at the time of screening or the time of surgery.\n13. Subjects who have participated previously in this clinical trial and who have been withdrawn.\n14. Subject does not meet the indication or is contraindicated for TKA according to specific Smith+Nephew LEGION Knee System IFU.","80 Years",{"count":139,"type":21},144,"The purpose of this study is to assess the long-term safety and performance of the LEGION Medial Stabilized insert and to generate clinical evidence to support and maintain product registration in global markets.",[142,143,144],"Inflammatory Arthritis","Primary Total Knee Arthroplasty Due to Degenerative Joint Disease (Primary Diagnosis of Osteoarthritis)","Post-traumatic Arthritis",[146,66,147,148],"Primary TKA","post-traumatic arthritis","inflammatory arthritis","NOT_YET_RECRUITING","2025-09-26",{"date":152,"type":38},"2025-09-30",{"date":154,"type":21},"2025-11",{"date":156,"type":21},"2036-12",{"name":44,"class":45},{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":17,"minAge":165,"maxAge":166,"enrollmentInfo":167,"targetDuration":169,"studyType":23,"phases":4,"briefSummary":170,"conditions":171,"keywords":175,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":130},"100509565","evaluation-of-outcomes-following-in-office-tympanostomy-using-the-tula-system-a-prospective-multi-center-registry-100509565","NCT05915078","Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry","Evaluation of Clinical and Health Economic Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry","Inclusion Criteria:\n\n* Patients ages 6 months through 17 years of age (inclusive) at time of tympanostomy in-office using the Tula® System\n* Patients who are candidates for in-office tube placement using the Tula System according to the System Instructions For Use\n\nExclusion Criteria:\n\n* Patients who are wards are not included","6 Months","17 Years",{"count":168,"type":21},200,"2 Years","This prospective, single-arm, multicenter registry is being conducted to collect real world post-market data from patients aged from 6 months to 17 years of age who are undergoing an in-office ear tube placement procedure (tympanostomy) using the Tula® System. The Registry will include up to 20 centers in the US and up to 200 patients for the initial evaluation.\n\nThe FDA-approved Tula System includes the Tula Iontophoresis System (IPS) with TYMBION™ otic anesthetic for local anesthesia of the ear drum and the Tula Tube Delivery System (TDS) for ear tube placement. Clinical research established the safety, efficacy and tolerability of this system for in-office procedures in the pediatric population. Patients will be treated and evaluated according to standard medical care. Outcome data is collected up to 6 months following extrusion or removal of their tube(s).",[172,173,174],"Otitis Media With Effusion","Acute Otitis Media","Otitis Media",[176,177,178,179,180],"Otitis media","pediatric","tympanostomy","office procedure","local anesthesia","2024-07-19",{"date":183,"type":38},"2024-07-23",{"date":185,"type":38},"2023-06-15",{"date":187,"type":21},"2027-06-30",{"name":44,"class":45},{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":198,"conditions":199,"keywords":202,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":213},"100540674","aetos-shoulder-system-100540674","NCT06319911","AETOS Shoulder System","AETOS Shoulder System Post Market Clinical Investigation","Inclusion Criteria:\n\nPatients must meet all the following criteria to be included in the study:\n\n1. Patient is at least 18 years of age at the time of consent and skeletally mature.\n2. Patient is undergoing a primary elective anatomic or reverse shoulder replacement surgery for one of the following indications:\n\n   * Rheumatoid arthritis, and\u002For\n   * Traumatic arthritis (Post Traumatic arthritis), and\u002For\n   * Non-inflammatory degenerative joint disease, and\u002For\n   * Correction of functional deformity.\n3. Patient is willing and able to accommodate all study-related procedures and visits detailed in the protocol \\& cooperate in the standard of care post-operative therapy.\n4. Patient is geographically stable and willing to return to the study site for all follow-up visits.\n5. Patient has been adequately informed of risks and requirements of the study and is willing and able to provide informed consent for participation.\n\n   \\-\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria will not qualify for participation in the trial:\n\n1. Patient has a contraindication to AETOS.\n2. Patient is undergoing a revision shoulder replacement surgery including total or partial arthroplasty.\n3. Patient is indicated for a Hemiarthroplasty.\n4. Patient has traumatic injury or a fracture.\n5. Patient has uncontrolled diabetes with a hemoglobin A1C of 7.5 or greater.\n6. Patient has comorbidities\u002Fconditions that preclude proper healing\u002Ffixation of the implant.\n7. Patient has poor quality or insufficient bone stock to support the implant.\n8. Patient has poor bone quality where there could be considerable migration of the implant and\u002For a chance of fracture.\n9. Patient has rapid joint destruction, marked bone loss or bone resorption (e.g., severe osteoporosis).\n10. Patient has osteomalacia.\n11. Patient has muscular, neurologic, or vascular deficiencies that may compromise the outcome of the shoulder replacement surgery.\n12. Patient has a known sensitivity, allergic reaction, and\u002For known allergies to one or more of the implanted materials.\n13. Patient has a distant foci of infection which may spread to the implant site, active local or systemic infection, sepsis, or osteomyelitis.\n14. Patient has an elevation of sedimentation rate, elevation of WBC count, or marked shift in WBC differential count unexplained by other disease.\n15. If reverse shoulder arthroplasty, patient has a non-functional deltoid or external rotator muscles.\n16. If reverse shoulder arthroplasty, patient has a significant injury to the upper brachial plexus.\n17. If reverse shoulder arthroplasty, patient has paralysis of the axillary nerve.\n18. Patient is uncooperative, has a neurologic disorder and is not capable of following directions, or is a vulnerable subject per ISO 14155 (i.e., individuals who are 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).\n19. Patient is pregnant or plans to become pregnant during the follow-up period.\n20. Patient has a Body Mass Index (BMI) of \\>35kg\u002Fm2 or a BMI that may compromise the outcome of the shoulder replacement surgery.\n21. Patient has anticipated activities which would impose high stresses on the implant and its fixation or has a high likelihood of a fall.\n22. Patient is a known smoker, vaper, alcohol abuser, or drug abuser within 180 days of consent.\n23. Patient has participated previously in this clinical trial and was withdrawn.\n24. Patient is participating in another device or drug trial or observational competitive study.",{"count":197,"type":21},220,"The goal of this study is to confirm the safety and performance of the AETOS Shoulder System for USA adoption. This is a prospective, open, adaptive, non-comparative, multi-centre investigation enrolling a maximum of 220 subjects in 2 cohorts (anatomic and reverse) at up to 15 sites. No intra-study comparator group will be included, and there will be no randomization",[200,201],"Shoulder Osteoarthritis","Shoulder Arthritis",[203,204],"Shoulder","arthroplasty","2024-05-06",{"date":207,"type":38},"2024-05-07",{"date":209,"type":38},"2024-03-05",{"date":211,"type":21},"2030-08-30",{"name":44,"class":45},5,""]