[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Limacorporate S.p.a\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":277},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,40,59,83,105,126,145,165,190,212,248],{"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":25,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100543702","h-34-delta-revision-cup-100543702",false,"NCT06359301","H-34 DELTA Revision Cup","An Open Label, Observational, Prospective, Longitudinal Cohort Study to Evaluate Safety, Clinical and Radiographic Outcomes of Total Hip Arthroplasty With DELTA Revision Cup","Inclusion Criteria:\n\n* male or female in whom a decision has already been made to perform a total hip arthroplasty with DELTA Revision acetabular cup as per indication for use. The decision to implant DELTA revision acetabular cup must be taken prior to, and independently from the decision to enroll the patient. This decision should be made in accorsance with routine clinical practice at the study site concerned.\n* Age ≥ 18 years old\n* All patients mist give written informed consent approved by the study site's Institutinal Review Board (IRB)\u002FEthical Committee (EC)\n* Patient is able to comply with the protocol\n\nExclusion Criteria:\n\n* Adult patients with any DELTA Revision acetabular cup contraindication for use as reported in the current local instruction for use.\n* For female patiens, current pregnancy and\u002For lactation or planning a pregnancy","ALL","18 Years",{"count":19,"type":20},49,"ESTIMATED","OBSERVATIONAL","THis study is aimed to provide a clinical and radiographic evaluation of 49 suitable subjects who underwent a total hip arthroplasty with DELTA Revision acetabular cup.",[24],"Hip, Osteoarthritis",[26],"revision","RECRUITING","2026-01-20",{"date":30,"type":31},"2026-01-22","ACTUAL",{"date":33,"type":31},"2021-09-14",{"date":35,"type":20},"2028-12",{"name":37,"class":38},"Limacorporate S.p.a","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":49,"conditions":50,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":52,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":58},"100541996","physica-tt-tibial-plate-follow-up-study-100541996","NCT06337123","Physica TT Tibial Plate Follow up Study","A Post Market Clinical Study Evaluating Clinical and Radiographic Outcomes of Total Knee Arthroplasty With Physica Porous KR or Physica Porous PS in Combination With Physica TT Tibial Plate in Cementless Configuration.","Inclusion Criteria:\n\n1. Male or female of any race requiring a total knee replacement (TKR) and suitable for receiving Physica Porous KR or Physica Porous PS femoral component in combination with Physica TT Tibial Plate.\n2. Age ≥ 18 years old.\n3. Candidate for primary total knee replacement when clinical indications based on physical examination and medical history include one or more of the following conditions:\n\n   1. Non-inflammatory degenerative joint disease like knee osteoarthritis, post traumatic knee arthritis\n   2. Inflammatory degenerative joint disease like rheumatoid arthritis\n   3. Any other medical reason for which the investigator deems the subject as a possible candidate for total knee replacement.\n4. Patient has well-preserved and well-functioning collateral ligaments and one of the following conditions:\n\n   1. Absent or not-functioning posterior cruciate ligament and severe antero-posterior instability of the knee joint (for Physica Porous PS)\n   2. Undamaged and functional posterior cruciate ligament (for Physica Porous KR)\n5. Patient is able to understand the conditions of the study, to comply with the prescribed rehabilitation as well as willing to perform all scheduled follow-up visits.\n6. Patient signed the study-specific informed consent form approved by the ethics committee before study activities\n\nExclusion Criteria:\n\n1. Severe instability of the knee joint secondary to the absence of collateral ligament integrity and\u002For function. Only for Physica Porous KR: important joint instability and deficiency of posterior cruciate ligament.\n2. Any active or suspected infection (local or systemic) or previous history of infection that may affect the prosthetic joint.\n3. Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy.\n4. Significant bone loss on femoral or tibial joint side.\n5. Affected by malignant cancer with life expectancy less than 2 years or where cancer treatment might affect the normal postoperative course.\n6. Known incompatibility or allergy to the product materials, and\u002For metal hypersensitivity to implant materials.\n7. Septicaemia.\n8. Persistent acute or chronic osteomyelitis.\n9. Open epiphyses (immature patient with active bone growth).\n10. Necrotic bone\n11. Arterial vascular insufficiency or nerve diseases of the lower limbs severe enough to interfere with the study evaluation.\n12. Compromised bone stock due to disease, infection or prior implantation that cannot provide adequate support and\u002For fixation to the prosthesis.\n13. Systemic or metabolic disorders leading to progressive bone deterioration, which may impair fixation and stability of the implant.\n14. Any concomitant disease and dependency that might affect the performance of the implanted prosthesis.\n15. Any clinically major pathology based on clinical medical history or any medical intervention or reason that the Investigator feels may affect the study evaluation.\n16. Neurological or musculoskeletal disorder or disease that may adversely affect gait, functional recovery and evaluation.\n17. Neuromuscular or neurosensory deficit that would hamper the performance assessment of the device.\n18. Any psychiatric illness that would prevent comprehension of the details and nature of the study.\n19. Simultaneously taking part in another surgical intervention study or pain management study that may affect with clinical study outcomes.\n20. Female patient who is pregnant, nursing, or planning a pregnancy.\n21. Important osteoporosis, haemophilic disease.\n22. Internistic problems with high risk for surgery.",{"count":48,"type":20},130,"This clinical study aims at evaluating clinical, radiographic, patient-reported outcomes of total knee arthroplasty with Physica TT Tibial Plate in combination with Physica Porous KR or Physica Porous PS up to 2 years after surgery, in order to assess the performance of the devices. Furthermore, ithe objective is to collect short-term survivorship of the implant and the incidence of early complications.",[51],"Knee Arthropathy",{"date":30,"type":31},{"date":54,"type":31},"2025-04-15",{"date":56,"type":20},"2029-04",{"name":37,"class":38},3,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":82,"locationsCount":39},"100584132","cocrmo-lock-bipolar-femoral-heads-fu-100584132","NCT06885359","CoCrMo LOCK Bipolar Femoral Heads FU","A Post-market Study Evaluating Clinical and Safety Outcomes of Bipolar Hemiarthroplasty Using CoCrMo LOCK Bipolar Femoral Heads in Subjects with Hip Fracture","Inclusion Criteria:\n\n* Displaced intracapsular hip fracture (Garden III-IV).\n* Subjects underwent a Bipolar Hemiarthroplasty with a CoCrMo LOCK Bipolar femoral head as per their Indication For Use from January 1st, 2023, onwards.\n* No concurrent joint disease at the time of the surgery.\n* Absence of severe cognitive dysfunction demonstrated by 3 or more correct answers on the Pfeiffer test.\n* Ability to ambulate independently with or without walking aids before surgery.\n* Subject willingness to participate.\n\nExclusion Criteria:\n\n* Undisplaced or minimally displaced intracapsular hip fracture (Garden I-II).\n* Any CoCrMo LOCK Bipolar femoral head contraindication for use as reported in the current Instruction For Use.\n* Pathological fracture secondary to malignant disease.\n* Subjects with rheumatoid arthritis or symptomatic osteoarthritis.\n* Previous treatment to the same hip for a fracture at the time of the surgery.\n* Subjects who were deemed unsuitable for the surgical procedures by the anesthesiologist.\n* Severe cognitive dysfunction or cognitive impairment demonstrated by 2 or less correct answers on the Pfeiffer test.\n* Unable to walk before surgery (e.g., wheelchair or bed-ridden subjects).",{"count":67,"type":20},60,"Study design: monocentric, retrospective, observational and post-market clinical study.\n\nPurpose: To demonstrate the safety and performance of CoCrMo LOCK bipolar femoral heads. The eligible study population is represented by the entire population that underwent a hip replacement with CoCrMo LOCK bipolar femoral heads from 1st January 2023 onwards at the site in accordance with the indication for use of the product.",[70,71],"Femoral Fractures","Hip Arthropathy",[73,74],"Femoral head","Partial Hip Arthroplasty","NOT_YET_RECRUITING","2025-03-24",{"date":78,"type":31},"2025-03-26",{"date":80,"type":20},"2025-10",{"date":35,"type":20},{"name":37,"class":38},{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":102,"leadSponsor":104,"locationsCount":39},"100583226","cephalic-femoral-heads-follow-up-100583226","NCT06873568","Cephalic Femoral Heads Follow Up","A Post-market Study Evaluating Clinical and Safety Outcomes of Unipolar Hemiarthroplasty Using Cephalic Femoral Heads in Subjects with Hip Fracture","Inclusion Criteria:\n\n* Displaced intracapsular hip fracture (Garden III-IV).\n* Subjects underwent a Unipolar Hemiarthroplasty with a Cephalic femoral head as per their Indication For Use from January 1st, 2023, onwards.\n* No concurrent joint disease at the time of the surgery.\n* Absence of severe cognitive dysfunction demonstrated by 3 or more correct answers on the Pfeiffer test.\n* Ability to ambulate independently with or without walking aids before surgery.\n* Subject willingness to participate.\n\nExclusion Criteria:\n\n* Undisplaced or minimally displaced intracapsular hip fracture (Garden I-II).\n* Any Cephalic femoral head contraindication for use as reported in the current Instruction For Use.\n* Pathological fracture secondary to malignant disease.\n* Subjects with rheumatoid arthritis or symptomatic osteoarthritis.\n* Previous treatment to the same hip for a fracture at the time of the surgery.\n* Subjects who were deemed unsuitable for the surgical procedures by the anesthesiologist.\n* Severe cognitive dysfunction or cognitive impairment demonstrated by 2 or less correct answers on the Pfeiffer test.\n* Unable to walk before surgery (e.g., wheelchair or bed-ridden subjects).",{"count":91,"type":20},47,"Study design: monocentric, retrospective, observational and post-market clinical study.\n\nPurpose: To demonstrate the safety and performance of cephalic femoral heads. The eligible study population is represented by the entire population that underwent a hip replacement with cephalic femoral heads from 1st January 2023 onwards at the site in accordance with the indication for use of the product.",[94,70],"Hip Arthroplasty Replacement",[96,97],"femoral head","Partial hip arthroplasty","2025-03-13",{"date":100,"type":31},"2025-03-18",{"date":80,"type":20},{"date":103,"type":20},"2027-12",{"name":37,"class":38},{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":58},"100463422","multigen-plus-cck-and-amf-tt-cones-follow-up-study-100463422","NCT05314491","Multigen Plus CCK and AMF TT Cones Follow Up Study","A Prospective, Post-marketing Study Evaluating Clinical and Radiographic Early Outcomes of Total Knee Arthroplasty With Multigen Plus CCK Alone or Involving the AMF TT Cones.","Inclusion Criteria:\n\n* Male or female.\n* Age ≥ 18 years old.\n* Given written informed consent approved by the reference Ethics Committee (EC).\n* Subjects in whom a decision has already been made to perform a Total Knee Arthroplasty with Multigen Plus system as per Indication For Use. The decision to implant a Multigen Plus CCK system, alone or involving the AMF TT cones, must be taken prior to, and independently from, the decision to enrol the subject. This decision should be made in accordance with routine clinical practice at the study site concerned.\n* Subjects able to comply with the Study Protocol.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years old.\n* Subjects with any Multigen Plus system contraindication for use, or any AMF TT cones contraindication for use when used in combination with the Multigen Plus CCK, as reported in the current Instruction For Use.\n* Any clinically significant pathology based on the medical history that the Investigator feels may affect the study evaluation.\n* Female subjects who are pregnant, nursing, or planning a pregnancy.\n* Previous knee replacement on the contralateral side within the last year and whose outcome is achieving an KSS \\\u003C 70 points.",{"count":113,"type":20},68,"This study is aimed to provide a clinical and radiographic evaluation of 68 condylar-constrained Total Knee Arthroplasty (TKA) using a single type of prosthesis (Multigen Plus CCK configuration), alone or involving the AMF TT cones, in patients with joint instability or inadequate ligament function, both in complex primary and revision procedures.",[116,117],"Total Knee Arthroplasty","Revision Total Knee Arthroplasty","2025-03-05",{"date":120,"type":31},"2025-03-10",{"date":122,"type":31},"2022-06-21",{"date":124,"type":20},"2026-07",{"name":37,"class":38},{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":138,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},"100430397","multigen-plus-h-study-and-amf-tt-cones-100430397","NCT04884542","Multigen Plus H Study and AMF TT Cones","A Prospective, Post-marketing Study Evaluating Clinical and Radiographic Early Outcomes of Revision Total Knee Arthroplasty With Multigen Plus H Alone or Involving AMF TT Cones.","Inclusion Criteria:\n\n* Male or female\n* Age ≥ 18 years old\n* Given written informed consent approved by the reference Ethics Committee (EC)\n* Subjects in whom a decision has already been made to perform a Total Knee Arthroplasty with the Multigen Plus H system as per Indication For Use. The decision to implant a Multigen Plus H system, alone or involving the AMF TT cones, must be taken prior to, and independently from, the decision to enrol the subject. This decision should be made in accordance with routine clinical practice at the study site concerned.\n* Subject is able to comply with the protocol\n\nExclusion Criteria:\n\n* Age \\< 18 years old\n* Subjects with any Multigen Plus system contraindication for use, or any AMF TT cones contraindication for use when used in combination with the Multigen Plus H, as reported in the current Instruction For Use.\n* Any clinically significant pathology based on the medical history or any medical intervention that the Investigator feels may affect the study evaluation\n* Female subjects who are pregnant, nursing, or planning a pregnancy\n* Previous knee replacement on the contralateral side within the last year and whose outcome is achieving an KSS \\< 70 points.",{"count":134,"type":20},43,"The aim of this study is to assess the clinical, patient-reported, and radiographic outcomes of a revision Total Knee Arthroplasty with Multigen Plus H and AMF TT Cones.",[137],"Arthroplasty, Replacement, Knee",{"date":120,"type":31},{"date":140,"type":31},"2022-01-19",{"date":142,"type":20},"2027-06-30",{"name":37,"class":38},2,{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":164,"locationsCount":4},"100579923","physica-tt-tibial-plate-prospective-study-100579923","NCT06830603","Physica TT Tibial Plate Prospective Study","A Post Market, Prospective Clinical Study Evaluating Clinical and Radiographic Outcomes of Patients Undergoing Total Knee Arthroplasty with Physica TT Tibial Plate","Inclusion Criteria:\n\n1. Patient requiring a total knee arthroplasty (TKA) and suitable for receiving Physica TT Tibial Plate;\n2. Age ≥ 18 years old;\n3. Candidate for primary total knee replacement when clinical indications based on physical examination and medical history include one or more of the following conditions:\n\n   1. Non-inflammatory degenerative joint disease such as knee osteoarthritis, post traumatic knee arthritis;\n   2. Inflammatory degenerative joint disease such as rheumatoid arthritis;\n4. Patient has well-preserved and well-functioning collateral ligaments\n5. Patient is able to understand the conditions of the study, is willing and able to follow all prescribed rehabilitation as well as willing to perform all scheduled follow-up visits;\n6. Patient has signed the study-specific Informed Consent Form prior to study activities\n\nExclusion Criteria:\n\n1. Patient is affected by one or more of the conditions that are stated as Physica contraindications for use, which are:\n\n   * Severe instability of the knee joint secondary to the absence of collateral ligament integrity and\u002For function.\n   * Any active or suspected infection (local or systemic) or previous history of infection that may affect the prosthetic joint.\n   * Significant bone loss on femoral or tibial joint side.\n   * Known incompatibility or allergy to the product materials, and\u002For metal hypersensitivity to implant materials.\n   * Septicaemia.\n   * Persistent acute or chronic osteomyelitis.\n   * Open epiphyses (immature patient with active bone growth).\n   * Necrotic bone\n   * Arterial vascular insufficiency or nerve diseases of the lower limbs severe enough to interfere with the study evaluation.\n   * Compromised bone stock due to disease, infection or prior implantation that cannot provide adequate support and\u002For fixation to the prosthesis.\n   * Systemic or metabolic disorders leading to progressive bone deterioration, which may impair fixation and stability of the implant.\n   * Any concomitant disease and dependency that might affect the performance of the implanted prosthesis.\n   * Important osteoporosis, haemophilic disease.\n   * Internistic problems with high risk for surgery.\n2. Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy.\n3. Affected by malignant cancer with life expectancy less than 2 years or where cancer treatment might affect the normal postoperative course.\n4. Any clinically major pathology based on clinical medical history or any medical intervention or reason that the Investigator feels may affect the study evaluation.\n5. Neurological or musculoskeletal disorder or disease that may adversely affect gait, functional recovery and evaluation.\n6. Neuromuscular or neurosensory deficit that would hamper the performance assessment of the device.\n7. Any psychiatric illness that would prevent comprehension of the details and nature of the study.\n8. Simultaneously taking part in another surgical intervention study or pain management study that may affect with clinical study outcomes.\n9. Female patient who is pregnant, nursing, or planning a pregnancy.",{"count":153,"type":20},142,"This prospective clinical study aims at evaluating clinical, radiographic, patient-reported outcomes of total knee arthroplasty with Physica TT Tibial Plate over 2 years after surgery, in order to assess the performance and safety of the devices. Short-term survivorship of the implant and the incidence of early complications are evaluated.",[156,157],"Knee Arthroplasty, Total","Knee Osteoarthritis","2025-02-11",{"date":160,"type":31},"2025-02-17",{"date":162,"type":20},"2025-05",{"date":35,"type":20},{"name":37,"class":38},{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":173,"conditions":174,"keywords":178,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":39},"100544664","prima-eu-retrospective--prospective-100544664","NCT06371833","PRIMA EU Retrospective & Prospective","A Multicentric Study Evaluating Clinical and Radiological Outcomes of PRIMA Humeral Stem in Total Shoulder Arthroplasty","Inclusion Criteria:\n\n1. Age ≥ 18 years old;\n2. Full skeletal maturity;\n3. Life expectancy over 24 months;\n4. Patient's joint anatomically and structurally suited to receive the selected implants and functional deltoid muscle;\n5. Patient meets at least one of the following indications:\n\n   For Anatomic configuration:\n   * non-inflammatory degenerative joint disease (i.e., osteoarthritis);\n   * inflammatory arthritis of the glenohumeral joint including rheumatoid arthritis;\n   * avascular necrosis of the humeral head;\n   * cuff tear arthropathy (CTA Heads only);\n\n   For Reverse configuration:\n   * rotator cuff tear arthropathy;\n   * osteoarthritiswith rotator cuff tear;\n   * rheumatoid arthritis with rotator cuff tear;\n   * massive irreparable rotator cuff tear;\n6. Patient is able to understand the conditions of the study, to comply with the prescribed rehabilitation as well as willing to perform all scheduled follow-up visits;\n7. Patient has signed the Informed Consent form previously approved by the Ethics Committee before study activities.\n\nExclusion Criteria:\n\n1. Patients who lack capacity to be able to provide informed consent to participate in the study.\n2. Local or systemic general infection;\n3. Septicaemia;\n4. Persistent acute or chronic local or systemic osteomyelitis;\n5. Confirmed neurologic lesion compromising shoulder joint function;\n6. Deltoid muscle insufficiency;\n7. Poor meta-epiphyseal bone stock compromising stability of the implant (severe fracture of the proximal humerus, meta-epiphyseal pseudoarthrosis, osteoporosis, osteomalacia, extended bone loss after previous prosthetic or non-prosthetic surgery);\n8. Affected by malignant cancer with life expectancy less than 2 years or where cancer treatment might affect the normal postoperative course;\n9. Serious muscular, neurological, or arterial vascular diseases compromising stability of the implant;\n10. Proximal humerus fracture sequelae with inadequate bone stock;\n11. Vascular or nerve diseases affecting the concerned limb;\n12. Metabolic disorders which may impair fixation and stability of the implant;\n13. Any concomitant disease that might affect the implanted prosthesis;\n14. Metal hypersensitivity to implant materials (CoCrMo);\n15. Patient with significant renal impairment;\n16. Lower mobility issues that may affect the study evaluation;\n17. Unwillingness or inability (due to physical or mental issues) to comply with rehabilitation and to return for follow-up visits and any psychiatric illness that would prevent comprehension of the details and nature of the study;\n18. Women of childbearing potential who are pregnant, nursing, or planning to become pregnant;\n19. Any clinically significant pathology based on the medical history that the Investigator feels may affect the study evaluation.",{"count":67,"type":20},"This clinical study aims at evaluating clinical, radiographic and patient-reported outcomes after total anatomic or reverse shoulder replacement using PRIMA humeral stem up to 24 months after surgery, in order to assess the short-term performance of the implant. Furthermore, the objective is also to collect short-term data on the survivorship of the implant and the incidence of complications.",[175,176,177],"Arthroplasty","Replacement","Shoulder",[179,180,181],"TSA","RSA","Shoulder replacement","2025-02-03",{"date":184,"type":31},"2025-02-05",{"date":186,"type":31},"2024-10-25",{"date":188,"type":20},"2026-12",{"name":37,"class":38},{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":198,"phases":199,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":4},"100453095","a-post-market-study-evaluating-clinical-and-radiographic-outcomes-of-total-elbow-arthroplasty-with-tema-100453095","NCT05180071","A Post-market Study Evaluating Clinical and Radiographic Outcomes of Total Elbow Arthroplasty With TEMA","Inclusion Criteria:\n\n1. Patient's age ≥ 18 years old.\n2. Patient has given written informed consent to participate to the trial and to his\u002Fher personal data processing\n3. According to the device indications for use, patient suffers from disability due to one or more of the following:\n\n   * Elbow joint destruction which significantly compromises the activities of daily living\n   * Non-Inflammatory degenerative joint disease including osteoarthritis and avascular necrosis with hemophilia.\n   * Rheumatoid arthritis or degenerative arthritis with incapacitating pain\n   * Correction of severe functional deformity.\n   * Treatment of acute or chronic fractures with distal humerus epicondyle involvement.\n   * Post-traumatic lesions or bone loss contributing to elbow instability or loss of motion\n   * Any other medical reason that the investigator determine that subject is a good candidate for a total elbow arthroplasty\n4. Patient has undergone a total elbow arthroplasty, receiving TEMA prosthesis.\n5. Patient is able to comply with the study protocol.\n\nExclusion Criteria:\n\nA patient will be excluded from the study participation if he\u002Fshe meets any of the following criteria:\n\n1. Patient is affected by one or more of the conditions that are stated as TEMA contraindications for use, which are:\n\n   * Local or systemic infection;\n   * Septicemia;\n   * Persistent acute or chronic 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   * Rapid joint destruction, marked bone loss or bone resorption.\n2. Patient suffers from a diaphyseal fracture\n3. For female patients, current pregnancy and\u002For lactation or planning a pregnancy.\n4. Only for patients implanted with the unlinked configuration of TEMA prosthesis, the intraoperative testing showed a bad quality of medial and lateral elbow ligaments.\n5. Patient is enrolled in another investigational drug\u002Fdevice study that in the opinion of the Investigator could interfere with this clinical trial",{"count":197,"type":20},59,"INTERVENTIONAL",[200],"NA","TEMA elbow system is a CE marked medical device, and within this clinical trial it is used according to its intended use. This is a Post Marketing Clinical Follow Up trial, with the main aim to collect evidences on the outcome data on this product, by analysing clinical scoring systems, radiographs and adverse event records within five years after the surgery, and thus to assess the short-term performance and safety of this implant.",[203],"Total Elbow Arthroplasty","2023-12-11",{"date":206,"type":31},"2023-12-12",{"date":208,"type":20},"2024-02-01",{"date":210,"type":20},"2029-06-30",{"name":37,"class":38},{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":16,"minAge":219,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":198,"phases":222,"briefSummary":223,"conditions":224,"keywords":231,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":247},"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":221,"type":20},800,[200],"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.",[225,226,227,228,229,230],"Osteoarthritis, Knee","Traumatic Arthritis","Avascular Necrosis","Degenerative Joint Disease of Knee","Rheumatoid Arthritis","Deformity of Knee",[232,233,234,235,236,237,238],"Physica KR","Physica CR","Physica PS","Kinematic Retaining","Cruciate Retaining","Posterior Stabilized","Physica System","2023-03-17",{"date":241,"type":31},"2023-03-21",{"date":243,"type":31},"2017-03-24",{"date":245,"type":20},"2030-03",{"name":37,"class":38},5,{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":257,"conditions":258,"keywords":265,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":276,"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":256,"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",[259,260,261,262,229,175,227,263,264],"Shoulder Arthritis","Shoulder Osteoarthritis","Arthrosis","Osteoarthritis","Humeral Fractures","Cuff Tear Arthropathy",[266,267,268,269],"Shoulder Joint","Shoulder Replacement","Arthritis with rotator cuff tear","Post traumatic fracture sequele","2022-03-29",{"date":272,"type":31},"2022-04-06",{"date":274,"type":20},"2022-04",{"date":56,"type":20},{"name":37,"class":38},""]