[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"shoulder-arthritis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:shoulder-arthritis":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,49,76,102,123,156,187,213,237],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100643683","prospective-case-series-evaluating-6-month-and-12-month-outcomes-after-cryoneurolysis-for-chronic-pain-100643683",false,"NCT07639060","Prospective Case Series Evaluating 6-Month and 12-Month Outcomes After Cryoneurolysis for Chronic Pain","Inclusion Criteria:\n\n* Diagnosis of chronic pain (generally pain duration of at least 3-6 months) localized to an anatomical region appropriate for cryoneurolysis as determined by the treating physician.\n* Planned cryoneurolysis procedure as part of standard clinical care.\n* Ability to provide written informed consent.\n* Ability and willingness to complete baseline and follow-up questionnaires.\n\nExclusion Criteria:\n\n* Cryoneurolysis performed as part of a separate investigational trial in which data sharing is not permitted.\n* Active infection or other clinical contraindication to the procedure as determined by the treating clinician.\n* Life expectancy of less than 12 months in the judgment of the treating clinician.\n* Any condition that, in the investigator's opinion, would interfere with study participation or completion of follow-up, such as severe psychiatric instability or active substance use that precludes reliable follow-up","ALL","18 Years",{"count":18,"type":19},80,"ESTIMATED","OBSERVATIONAL","To prospectively describe patient-centered and health utilization outcomes through 12 months after cryoneurolysis performed as routine clinical care for chronic pain at Yale.",[23,24,25,26,27,28,29,30,31,32,33,34,35,36],"Chronic Pain","PERIPHERAL NEUROPATHY","Occipital Neuralgia","Chronic Hip Pain","Hip Osteoarthritis","Knee Osteoarthritis","Spasticity","Chronic Low Back Pain","Lumbar Spondylosis","Cervical Spondylosis","Shoulder Arthritis","Causalgia","Chronic Pain Syndrome","Chronic Neck Pain","NOT_YET_RECRUITING","2026-06-05",{"date":40,"type":41},"2026-06-10","ACTUAL",{"date":43,"type":19},"2026-06",{"date":45,"type":19},"2028-07",{"name":47,"class":48},"Yale University","OTHER",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":15,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100639277","a-study-comparing-shoulder-replacement-techniques-for-patients-with-shoulder-arthritis-and-an-intact-rotator-cuff-100639277","NCT07584356","A Study Comparing Shoulder Replacement Techniques For Patients With Shoulder Arthritis And An Intact Rotator Cuff","A Randomized Trial Comparing Anatomic And Reverse Total Shoulder Replacement For Shoulder Arthritis With An Intact Rotator Cuff","SOAR","Inclusion Criteria\n\n* Shoulder arthritis\n* Intact rotator cuff\n* Glenoid retroversion less than 25°\n\nExclusion Criteria\n\n* Rotator cuff insufficiency\n* Fracture deformity\u002Fsequelae\n* Severe glenoid deformity (C glenoid, severe A2, B2 glenoid)\n* Current or previous infection of shoulder\n* Previous acromion fracture (not os acromiale)\n* Brachial plexopathy\n* Axillary neuropathy\n* Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.\n* Inability or unwillingness of individual or legal guardian\u002Frepresentative to give written informed consent.\n* Medical conditions that would make 2 years follow up unlikely\n* Non-English speaking","60 Years","85 Years",{"count":60,"type":19},108,"INTERVENTIONAL",[63],"NA","The purpose of this study is to determine if patients undergoing anatomic total shoulder arthroplasty (aTSA) will have improved patient reported outcome scores at 1 year compared to those undergoing reverse total shoulder arthroplasty (rTSA).",[33],"2026-05-07",{"date":68,"type":41},"2026-05-13",{"date":70,"type":19},"2026-07",{"date":72,"type":19},"2029-12",{"name":74,"class":48},"Mayo Clinic",1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":15,"minAge":83,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":75},"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)","20 Years",{"count":85,"type":19},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.",[88,89,90,33,91],"Shoulder Injuries","Shoulder Pain","Shoulder Fractures","Shoulder Disease","2026-04-22",{"date":94,"type":41},"2026-04-23",{"date":96,"type":19},"2026-04",{"date":98,"type":19},"2036-01",{"name":100,"class":101},"Zimmer Biomet","INDUSTRY",{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},"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.","100 Years",{"count":111,"type":19},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.",[89,88,90,91,33],"RECRUITING",{"date":116,"type":41},"2026-04-28",{"date":118,"type":41},"2025-06-19",{"date":120,"type":19},"2040-12",{"name":100,"class":101},2,{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":15,"minAge":83,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":61,"phases":132,"briefSummary":133,"conditions":134,"keywords":137,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":149,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},"100438054","zimmer-biomet-shoulder-arthroplasty-pmcf-100438054","NCT04984291","Zimmer Biomet Shoulder Arthroplasty PMCF","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\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":131,"type":19},584,[63],"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.",[90,33,135,136,88,89],"Shoulder Osteoarthritis","Shoulder Deformity",[138,139,140,141,142,143,144,145,146,147,148],"Total Shoulder Arthroplasty","Glenoid","Humeral Stem","Stem Adapter","Humeral Head","Humeral Bearing","Humeral Trays","Head Adapter","Reverse","Anatomic","Hemi",{"date":116,"type":41},{"date":151,"type":41},"2021-07-28",{"date":153,"type":19},"2033-08-15",{"name":100,"class":101},17,{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":165,"conditions":166,"keywords":173,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":75},"100378588","evaluating-hemidiaphragmatic-paralysis-with-prolonged-neural-blockade-from-an-interscalene-brachial-plexus-block-100378588","NCT04209504","Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block","Inclusion Criteria:\n\n* English speaking 18-80 year old ASA 1-3 patients\n* Primary shoulder surgery\n* Must live within a 25 mile radius\n\nExclusion Criteria:\n\n* ASA 4 or 5\n* Revision shoulder surgery\n* Diagnosis of chronic pain\n* Daily chronic opioid use (over 3 months of continuous opioid use)\n* Inability to communicate pain scores or need for analgesia\n* Infection at the site of block placement\n* Age under 18 years old or greater than 80 years old\n* Pregnant women (as determined by point-of-care serum bHCG)\n* Intolerance\u002Fallergy to local anesthetics\n* Weight \\\u003C50 kg\n* BMI \\> 40\n* severe pulmonary disease including chronic obstructive pulmonary disease and restrictive lung disease\n* Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.\n* Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance.\n* Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course.","80 Years",{"count":164,"type":19},60,"This prospective observational study aims to evaluate the incidence of hemidiaphragmatic paralysis in patients receiving interscalene brachial plexus nerve block with prolonged neural blockade. English speaking American Society of Anesthesiologists (ASA) 1-3 patients ages 18-80 receiving prolonged interscalene nerve block will be randomized into 3 groups: first group receiving a perineural catheter infusing 0.2% ropivacaine; the second group receiving a single shot injection of 10mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine and the third receiving 20mL liposomal bupivacaine plus 5mL bupivacaine (to be determined by the attending anesthesiologist).Primary outcome will be incidence of hemidiaphragmatic paralysis postoperative day 1 as measured by point of care (POCUS) ultrasound.",[167,89,88,33,91,168,169,170,171,172],"Shoulder Surgery","Rotator Cuff Tears","Rotator Cuff Injuries","Rotator Cuff Arthropathy of Left Shoulder","Rotator Cuff Arthropathy of Right Shoulder","Rotator Cuff Repair",[172,167,174,175,176,177],"Hemidiaphragmatic paralysis","Interscalene Block","Interscalene Catheter","Interscalene Liposomal Bupivacaine","2025-09-29",{"date":180,"type":41},"2025-10-01",{"date":182,"type":41},"2021-10-12",{"date":184,"type":19},"2026-08-31",{"name":186,"class":48},"Duke University",{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":195,"enrollmentInfo":196,"targetDuration":4,"studyType":61,"phases":198,"briefSummary":199,"conditions":200,"keywords":201,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":75},"100350203","study-of-personalized-instrument-in-total-shoulder-arthroplasty-the-pitsa-study-100350203","NCT03839758","Study of Personalized Instrument in Total Shoulder Arthroplasty The P.I.T.S.A. Study","Multicenter Randomised Study of Personalized Instrument in Total Shoulder Arthroplasty The P.I.T.S.A. Study","PITSA","Inclusion Criteria:\n\n* Patients with shoulder osteaoarthritis and AVN\n\nExclusion Criteria:\n\n* Patients with previous shoulder arthroplasty\n* Patients with inflammatory arthritis and tumor\n* Patients with previous shoulder surgery with metal implant\n* Patients refusing 2-year follow-up\n* Patients that does not speak English or French\n* Patients with current or previous shoulder infection\n* Patients with graft during surgery","99 Years",{"count":197,"type":19},112,[63],"Total shoulder arthroplasty is an effective procedure to improve patients function and to relieve shoulder pain in cases of glenohumeral arthritis. The main challenge of this procedure is implanting the glenoid component. Indeed, surgical exposure is difficult and proper visualization of the glenoid is demanding. The current free-hand method is not precise and especially unreliable in glenoids with severe deformity. Inappropriate reaming and glenoid positioning can cause more bone loss during surgery.\n\nIn anatomic prostheses, glenoid component fixation is demanding and is the first component to present loosening at long term follow-up. When it comes to reverse arthroplasty, the glenoid component, once again, requires the most attention. Malpositioning of the glenosphere can cause notching, loosening, and instability.\n\nIn order to prevent these complications, precision in glenoid implantation is key. To this end, intraoperative computer navigation would be a helpful tool, but the increased expenses in computer equipment represent massive costs and possibly increases in surgical time. A more affordable option is a personalized guide, for which the only extra expense is the customized guide. These guides are based on precise 3D CT scan templates. Previous studies have evaluated the precision of the guide in vivo and in vitro, but none have measured it in a randomized study. As it represents additional costs, its efficacy needs to be proven before widespread use.\n\nThis method may also provide secondary benefits, such as decreasing operating time, lowering short- and long-term complications, and improving efficacy.\n\nThe objective of this study is to evaluate the performance of a patient specific glenoid guide.",[33],[202,203],"Prothesis","Glenoid implantation","2025-09-16",{"date":206,"type":41},"2025-09-22",{"date":208,"type":41},"2019-10-08",{"date":210,"type":19},"2028-12",{"name":212,"class":48},"Université de Montréal",{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":222,"conditions":223,"keywords":224,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":236},"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":221,"type":19},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",[135,33],[225,226],"Shoulder","arthroplasty","2024-05-06",{"date":229,"type":41},"2024-05-07",{"date":231,"type":41},"2024-03-05",{"date":233,"type":19},"2030-08-30",{"name":235,"class":101},"Smith & Nephew, Inc.",5,{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":246,"conditions":247,"keywords":255,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":4},"100463414","s-11-smr-tt-hybrid-glenoid-and-cementless-finned-short-stem-100463414","NCT05314387","S-11 SMR TT Hybrid Glenoid and Cementless Finned Short Stem","A Multicentre, Prospective Clinical Study Analysing Outcomes of Shoulder Arthroplasty With SMR TT Hybrid Glenoid With or Without SMR Cementless Finned Short Stem","Inclusion Criteria:(Key)\n\n* Both genders;\n* Age ≥ 18 years old;\n* Full skeletal maturity;\n* Life expectancy over 5 years;\n* Patient is requiring primary unilateral arthroplasty based on physical examination and medical history;\n* Good bone quality evaluated by the Investigator and the intraoperative evaluation;\n* A diagnosis in the target shoulder of one or more of the S-11 SMR TT Hybrid Glenoid and Cementless Finned Short Stem Version Sep 2021 2.0 Confidential Page11 following:\n\n  1. Primary osteoarthritis;\n  2. Secondary osteoarthritis;\n  3. Post-traumatic arthritis;\n  4. Rheumatoid arthritis;\n  5. Avascular necrosis\n  6. acute fractures of the humeral head that cannot be treated with other fracture fixation methods;\n  7. cuff tear arthropathy (only in combination with CTA Heads);\n  8. Glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification.\n\nExclusion Criteria (Key):\n\n* Patient requiring revision shoulder arthroplasty;\n* Osteoporosis with a history of non-traumatic fractures;\n* Steroid injections within the previous 3 months;\n* Contralateral shoulder replacement within the previous 3 months;\n* Significant proven or suspicious infection of the target shoulder or any serious infectious disease before the study according to the Investigator;\n* Significant neurological or musculoskeletal disorders that may compromise functional recovery;\n* Not recovered axillary nerve palsy;\n* Non functioning deltoid muscle;\n* Known or suspicious hypersensitivity to the metal or other components and materials of the implant;\n* Participation in any experimental drug\u002Fdevice study within the 6 months prior to the preoperative visit;\n* Women of childbearing potential who are pregnant, nursing, or planning to become pregnant.\n\nThese are key eligibility criteria, other eligibility criteria apply.",{"count":245,"type":19},100,"Post-market, prospective, non randomized, open label, multicentre, clinical study analysing outcomes of shoulder arthroplasty with SMR TT Hybrid Glenoid with or without SMR Cementless Finned Short Stem",[33,135,248,249,250,251,252,253,254],"Arthrosis","Osteoarthritis","Rheumatoid Arthritis","Arthroplasty","Avascular Necrosis","Humeral Fractures","Cuff Tear Arthropathy",[256,257,258,259],"Shoulder Joint","Shoulder Replacement","Arthritis with rotator cuff tear","Post traumatic fracture sequele","2022-03-29",{"date":262,"type":41},"2022-04-06",{"date":264,"type":19},"2022-04",{"date":266,"type":19},"2029-04",{"name":268,"class":101},"Limacorporate S.p.a"]