[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"avascular-necrosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:avascular-necrosis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,41,74,107,131,162,187,208,241],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100587662","effect-of-hbot-on-femoral-head-avascular-necrosis-avn-100587662",false,"NCT06931301","Effect of HBOT on Femoral Head Avascular Necrosis (AVN)","Effect of Hyperbaric Oxygen Therapy on Osteonecrosis of the Femoral Head When Combined With 3D Navigated Core Decompression With Bone Marrow Aspirate Concentrate","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Diagnosed with femoral head avascular necrosis\n* Enrolled into Yale Avascular Necrosis Program\n* Avascular necrosis lesion is classified as ARCO I or ARCO II by Investigator\n* Surgical Candidate for Core Decompression using 3D image guidance with bone marrow aspirate concentrate\n\nExclusion Criteria:\n\n* Hip has already collapsed due to severe avascular necrosis (ARCO III or ARCO IV)\n* Medical comorbidities that prevent them from being a surgical candidate (example: obesity)\n* Absolute contraindications to HBOT, including severe decompensated cardiac failure or lung disease putting them at high risk for pneumothorax\n* Pregnant\n* Prisoner\n* Does not sign Informed Consent Form","ALL","18 Years",{"count":19,"type":20},400,"ESTIMATED","INTERVENTIONAL",[23],"NA","The primary objective of this study is to determine whether the Hyperbaric Oxygen Therapy (HBOT) conducted under the Marx Protocol improves pain outcomes when combined with core decompression with autologous bone marrow aspirate concentrate to treat patients with femoral head avascular necrosis.",[26,27],"Osteonecrosis","Avascular Necrosis","NOT_YET_RECRUITING","2026-06-30",{"date":31,"type":32},"2026-07-01","ACTUAL",{"date":34,"type":20},"2026-12",{"date":36,"type":20},"2035-04",{"name":38,"class":39},"Yale University","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":51,"conditions":52,"keywords":57,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100645227","post-market-clinical-follow-up-pmcf-study-evaluating-the-safety-and-efficacy-of-tpmed-shoulder-prosthesis-system-100645227","NCT07678034","Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Shoulder Prosthesis System","A Multicenter, Prospective, Observational, Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Shoulder Prosthesis System","Inclusion Criteria:\n\n* Individuals aged 18 years and older,\n* Male or female participants,\n* Participants who have undergone Reverse Shoulder Arthroplasty or Shoulder Hemiarthroplasty for any valid indication,\n* Participants in whose surgical procedure the Tipmed™ Shoulder Prosthesis System product configurations were utilized.\n* Participants who are not legally restricted (e.g., military personnel, convicts, or individuals under legal guardianship).\n* Participants who have voluntarily signed the written Informed Consent Form (ICF).\n\nExclusion Criteria:\n\n* Concurrent participation in any other interventional clinical trial.",{"count":49,"type":20},54,"OBSERVATIONAL","This study is designed as a prospective, multicenter, observational post-market clinical follow-up (PMCF) study to evaluate the safety and effectiveness of the Tipmed™ Shoulder Prosthesis System at 12 months postoperatively. The study population includes adult patients who undergo reverse shoulder arthroplasty (RSA) or shoulder hemiarthroplasty (HA) using the Tipmed™ implant systems due to various clinical indications such as osteoarthritis, rotator cuff arthropathy, or proximal humerus fractures. The main objective is to gather real-world clinical evidence on the 12-month post-operative safety profile, potential complications, and functional outcomes of the device during routine clinical practice.",[53,54,55,56,27],"Glenohumeral Osteoarthritis","Proximal Humerus Fracture","Rotator Cuff Arthropathy","Rheumatoid Arthritis",[58,59,60,61,62],"Reverse Shoulder Arthroplasty","Shoulder Prosthesis","Shoulder Hemiarthroplasty","Post-Market Clinical Follow-Up (PMCF)","Modified Constant-Murley Score","RECRUITING","2026-06-24",{"date":31,"type":32},{"date":67,"type":32},"2025-06-16",{"date":69,"type":20},"2030-06-15",{"name":71,"class":72},"TIPMED Medical Device Manufacturing Ltd. Co.","INDUSTRY",4,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":40},"100517368","phase-2-alendronate-for-osteonecrosis-in-adults-with-sickle-cell-disease-100517368","NCT06016634","Alendronate for Osteonecrosis in Adults With Sickle Cell Disease","A Feasibility Study of Alendronate as Treatment for Osteonecrosis in Adults With Sickle Cell Disease","Inclusion Criteria:\n\n* Age 18-80 years with SCD (any genotype, confirmed by hemoglobin electrophoresis or high performance liquid chromatography)\n* Ability to provide written informed consent\n* Ability to lay on a dual-energy X-ray absorptiometry (DXA) scanner\n* Negative urine pregnancy test for anyone of childbearing potential at study entry\n\nExclusion Criteria:\n\n* Pregnant women\n* Adults unable to consent\n* Individuals who are not yet adults (infants, children, teenagers)\n* Prisoners\n* Hospitalizations (for any cause) within 2 weeks of study entry","80 Years",{"count":83,"type":20},30,[85],"PHASE2","A prospective, single-arm, intervention study of oral alendronate in adults with sickle cell disease and osteonecrosis",[88,89,26,90,27],"Sickle Cell Disease","Sickle Cell Anemia","Ischemic Necrosis",[92,93,94,95,96,97],"sickle cell disease","sickle cell anemia","osteonecrosis of the femoral head","hip osteonecrosis","ischemic necrosis of the femur","avascular necrosis of the femur","2026-04-08",{"date":100,"type":32},"2026-04-13",{"date":102,"type":32},"2026-03-09",{"date":104,"type":20},"2027-12-31",{"name":106,"class":39},"University of California, Davis",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100444447","perform-humeral-system-study-100444447","NCT05067543","Perform Humeral System Study","PHS","Inclusion Criteria:\n\n* 18 years or older at the time of the informed consent or non-opposition (when applicable).\n* Informed and willing to sign an informed consent form approved by IRB or EC (when applicable).\n* Willing and able to comply with the requirements of the study protocol.\n* Considered a candidate for shoulder arthroplasty using a study device.\n* Meets indications for use requirements or other local, regional, or geographic specific regulatory requirements\n\nExclusion Criteria:\n\n* Not able to comply with the study procedures based on the judgment of the assessor (e.g. cannot comprehend study questions, inability to keep scheduled assessment times)\n* Patient belongs to a vulnerable group of patients, including minor patients, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion (patients who may not be acting on their own initiative) (referred as \"vulnerable subject\" in the section 3.44 of the ISO 14155 norm).\n* Active local or systemic infection, sepsis, or osteomyelitis\n* Poor bone quality, where there could be considerable migration of the prothesis and\u002For a chance of fracture of the humerus or glenoid\n* Significant injury to the brachial plexus\n* Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components\n* Neuromuscular disease (e.g., joint neuropathy)\n* Patient with known allergy to one of the product materials\n* Metabolic disorders which may impair bone formation\n* Patient pregnancy\n* Planned for two-stage surgery",{"count":115,"type":20},300,"This study is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up study, which is designed to collect safety and performance data at baseline, surgery, immediate post-op and annually through 10 years post-operation.\n\nData collected from this study will be used for purposes, including but not limited to, Post-Market Surveillance, peer-reviewed publications, education materials, regulatory submissions, and\u002For product development.",[118,27,119,120],"Osteoarthritis Shoulder","Post-traumatic Arthrosis of Other Joints, Shoulder Region","Rotator Cuff Tear Arthropathy","2026-02-19",{"date":123,"type":32},"2026-02-20",{"date":125,"type":32},"2021-09-12",{"date":127,"type":20},"2036-12-01",{"name":129,"class":72},"Stryker Trauma and Extremities",10,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":140,"conditions":141,"keywords":149,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":161},"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":139,"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",[142,143,56,144,145,146,147,148,27],"Knee Pain Chronic","Osteoarthritis, Knee","Traumatic Arthritis","Polyarthritis","Varus Deformity","Valgus Deformity","Flexion Deformity of Knee",[150,151],"Osteoarthritis","Total Knee Arthroplasty","2026-01-15",{"date":154,"type":32},"2026-01-20",{"date":156,"type":32},"2023-06-28",{"date":158,"type":20},"2035-06",{"name":160,"class":72},"Zimmer Biomet",16,{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":171,"conditions":172,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":40},"100510452","clinical-and-radiological-outcomes-of-medacta-shoulder-system-fr-100510452","NCT05926622","Clinical and Radiological Outcomes of Medacta Shoulder System FR","Clinical and Radiological Outcomes of Medacta Shoulder System","Inclusion Criteria:\n\n* Patients older than 18 years\n* Patient with one of the following diagnosis:\n\nPrimary osteoarthritis Secondary osteoarthritis Cuff tear arthropathy; insufficient rotator cuff Acute fracture (\\\u003C21d) Rheumatoid or inflammatory arthritis Avascular necrosis Other posttraumatic condition Revision of shoulder arthroplasty\n\nExclusion Criteria:\n\n* Patients with malignant diseases (at the time of surgery)\n* Patients with proven or suspect infections (at the time of surgery)\n* Patients with functional deficits other than dysfunction of the shoulder (at the time of surgery)\n* Patients with known incompatibility or allergy to products materials (at the time of surgery)",{"count":170,"type":20},200,"This is a post-marketing surveillance on Medacta Shoulder System",[173,174,120,175,27,176,177],"Primary Osteoarthritis","Secondary Osteoarthritis","Rheumatoid Arthritis Shoulder","Fracture","Revision of Shoulder Arthroplasty","2025-09-23",{"date":180,"type":32},"2025-09-29",{"date":182,"type":32},"2022-03-15",{"date":184,"type":20},"2037-03",{"name":186,"class":72},"Medacta International SA",{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":21,"phases":196,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":40},"100491446","hydrogel-coating-to-reduce-post-surgical-infection-after-joint-arthroplasty-100491446","NCT05679232","Hydrogel Coating to Reduce Post-surgical Infection After Joint Arthroplasty","Randomized, Controlled, Monocentric, Feasibility Clinical Investigation to Assess the Safety and Preliminary Clinical Performance of a Hydrogel Coating to Reduce Post-surgical Infection After Joint Arthroplasty","Inclusion Criteria:\n\n* Informed Consent signed by the subject\n* Males and females aged over 18 years at time of surgery\n* Subjects who are scheduled to receive a conical collarless cementless revision hip arthroplasty, with or without revision of the acetabular cup\n* Subjects willing to comply with the pre- and post-operative evaluation schedule\n\nExclusion Criteria:\n\n* Subjects with one or more medical conditions identified as a contraindication defined by the labelling on any implants used in this study\n* Subjects with immune suppressive treatment for organ transplantation, or known allergy to MectaShield hydrogel constituents (Chitlac, Mannitol, Hydroxypropylmethylcellulose, Sodium phosphate dibasic)\n* Subjects presenting with progressive local or systemic infection at the time of surgery\n* Subjects whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems\n* Subjects affected by concomitant spine, hip, ankle or contralateral knee pathologies that can affect walking capacity\n* Subjects unable to understand and take action\n* Subjects undergoing cementless revision hip arthroplasty in emergency interventions",{"count":195,"type":20},56,[23],"The goal of this randomized, controlled, monocentric, single-blind, 2-arm, feasibility clinical investigation is to evaluate the safety of MectaShield hydrogel coating and to capture its preliminary clinical performance in the prevention of early peri-prosthetic joint infection (PJI) in patients undergoing cementless revision hip arthroplasty.\n\nThe main questions it aims to answer are:\n\n* demonstrate that the hydrogel coating MectaShield does not interfere with primary stability;\n* evaluate clinical and functional outcomes, the rate of PJI and possible adverse events.\n\nParticipants will undergo cementless revision hip arthroplasty; during surgery MectaShield hydrogel coating is applied on orthopaedic implants' surfaces (femoral stem and, if revised, acetabular cup) as a protective barrier for the prevention of bacterial adhesion. Surgery and follow-up are completed as per local standard practice. Stability will be assessed radiologically, while functional outcomes and PJI will be monitored by HOOS-PS, ASESPIS scores and according to the consensus document presented by European Society of Radiology (ESRa), the European Association of Nuclear Medicine (EANM), the European Bone and Joint Infection Society (EBJIS), and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID). Researchers will compare the results of the treatment group with those from a control group receiving cementless revision hip arthroplasty without the application of MectaShiled hydrogel coating.",[199,144,27],"Arthritis","2025-05-07",{"date":202,"type":32},"2025-05-11",{"date":204,"type":32},"2022-12-06",{"date":206,"type":20},"2027-12-06",{"name":186,"class":72},{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":16,"minAge":215,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":21,"phases":218,"briefSummary":219,"conditions":220,"keywords":223,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":240},"100289472","physica-system-total-knee-replacement-registry-study-100289472","NCT03048201","Physica System Total Knee Replacement Registry Study","Post-market Registry Study on the Physica System Total Knee Replacement","Inclusion Criteria:\n\n1. Males and females of any race requiring a total knee replacement and suitable for the use of one of the configurations of the Physica system\n2. Age\\> 22 (skeletally mature)\n3. Patients who are suffering from non-inflammatory degenerative joint disease (NIDJD):\n\n   including knee osteoarthritis, post-traumatic knee arthritis; or patients who are suffering from inflammatory arthritis; or patients that need correction of a functional deformity\n4. Suitable candidates for TKR who have undamaged and functional collateral ligaments\n5. Suitable candidates for TKR with Physica KR, CR, who have an undamaged and functional posterior cruciate ligament; or Physica LMC with or without a functioning posterior cruciate ligament or Physica PS with an absent or not-functioning posterior cruciate ligament and\u002For severe antero-posterior instability of the knee joint\n6. Patients who understand the conditions of the study and are willing and able to comply with the prescribed rehabilitation and to perform all scheduled follow-up visits\n7. Patients who have signed the Ethics Committee\u002FIRB approved study-specific Informed Consent Form prior to the surgery\n\nExclusion Criteria:\n\n1. Patients with severe instability of the knee joint secondary to the absence of collateral ligament integrity and\u002For function\n2. Patients with active or any suspected infection (on the affected knee or systemic)\n3. Previous partial knee replacement (unicompartimental, bicompartimental or patellofemoral joint replacement), patellectomy, high tibial osteotomy\n4. Patients with significant bone loss on femoral or tibial joint side\n5. Current treatment for malignant and\u002For life-threatening non-malignant disorders\n6. Patients with known incompatibility or allergy to the product materials, and\u002For metal hypersensitivity to implant materials\n7. Vascular insufficiency of lower limbs severe enough to interfere with the study evaluation\n8. Patients with bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and\u002For fixation to the prosthesis\n9. Patients with systemic or metabolic disorders leading to progressive bone deterioration which may impair fixation and stability of the implant\n10. Any concomitant disease and dependence that might affect the performance of the implanted prosthesis\n11. Any clinically significant pathology based on clinical history that the Investigator feels may affect the study evaluation (e.g. primary osteoporosis with significant bone loss, haemophilic disease, septicaemia, persistent acute or chronic osteomyelitis)\n12. Patients who have significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery and evaluation\n13. Patients who have neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device\n14. Previous history of infection in the affected joint and\u002For other local\u002Fsystemic infection that may affect the prosthetic joint\n15. Any psychiatric illness that would prevent comprehension of the details and nature of the study\n16. Patients currently participating in any other surgical intervention studies or pain management studies\n17. Female patients who are pregnant, nursing, or planning a pregnancy","22 Years",{"count":217,"type":20},800,[23],"The primary objective of this study is to obtain long-term implant survivorship (out to 10 years) and to assess clinical, patient-reported outcome measures, and radiographic data for the commercially available Physica system. For ancillary arm, from baseline to 5-year follow-up.",[143,144,27,221,56,222],"Degenerative Joint Disease of Knee","Deformity of Knee",[224,225,226,227,228,229,230],"Physica KR","Physica CR","Physica PS","Kinematic Retaining","Cruciate Retaining","Posterior Stabilized","Physica System","2023-03-17",{"date":233,"type":32},"2023-03-21",{"date":235,"type":32},"2017-03-24",{"date":237,"type":20},"2030-03",{"name":239,"class":72},"Limacorporate S.p.a",5,{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":250,"conditions":251,"keywords":258,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"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":249,"type":20},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",[252,253,254,150,56,255,27,256,257],"Shoulder Arthritis","Shoulder Osteoarthritis","Arthrosis","Arthroplasty","Humeral Fractures","Cuff Tear Arthropathy",[259,260,261,262],"Shoulder Joint","Shoulder Replacement","Arthritis with rotator cuff tear","Post traumatic fracture sequele","2022-03-29",{"date":265,"type":32},"2022-04-06",{"date":267,"type":20},"2022-04",{"date":269,"type":20},"2029-04",{"name":239,"class":72}]