[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Medacta International SA\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":331},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,39,68,86,106,126,149,173,194,215,235,259,278,295,312],{"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":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100640881","mfinity-be-pre-market-trial-100640881",false,"NCT07616895","MFinity BE Pre-market Trial","Prospective Single-arm Clinical Study Assessing the Safety and Effectiveness of a Novel Femoral Stem for Total Hip Arthroplasty.","Inclusion Criteria:\n\n* Patients undergoing elective primary total hip arthroplasty for primary osteoarthritis, who are suitable for implantation of a cementless femoral stem according to the MFinity femoral stem Instructions for Use\n* Skeletally mature adult aged 18 years and older at the time of enrollment.\n* Ability to give informed consent.\n* Patient is informed of the conditions of the study and is willing to participate for the length of the prescribed follow-up period.\n\nExclusion Criteria:\n\n* Not meeting the inclusion criteria.\n* Active infection within the affected hip joint.\n* Previous total hip replacement or hip fusion of the affected hip joint.\n* Neuromuscular or neurosensory deficiency limiting the ability to evaluate the safety and effectiveness of the device.\n* Bone condition that may compromise the stability of the implant\n* Known allergy or hypersensitivity to the implant material\n* Immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.\n* For women of childbearing potential\\*: a positive pregnancy test\n* Patients with severe osteoarthritis in the contralateral hip or other joints that may interfere with the assessment of study outcomes.\n* Patients who have previously participated in this clinical trial.\n\n  * a woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. Women using one of the following birth control methods are not considered of childbearing potential: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable),intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, and sexual abstinence.","ALL","18 Years",{"count":19,"type":20},95,"ESTIMATED","INTERVENTIONAL",[23],"NA","The primary objective of this trial is to determine the implant survival at 1 year of follow up in a population of patients undergoing primary Total Hip Replacement with MFinity Collared Femoral stem and to test its non-inferiority compared to other cementless implant (as reported by the EPRD registry).",[26],"Total Hip Arthroplasty (THA)","NOT_YET_RECRUITING","2026-05-27",{"date":30,"type":31},"2026-06-01","ACTUAL",{"date":33,"type":20},"2026-06",{"date":35,"type":20},"2029-06",{"name":37,"class":38},"Medacta International SA","INDUSTRY",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":48,"phases":4,"briefSummary":49,"conditions":50,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"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":47,"type":20},200,"OBSERVATIONAL","This is a post-marketing surveillance on Medacta Shoulder System",[51,52,53,54,55,56,57],"Primary Osteoarthritis","Secondary Osteoarthritis","Rotator Cuff Tear Arthropathy","Rheumatoid Arthritis Shoulder","Avascular Necrosis","Fracture","Revision of Shoulder Arthroplasty","RECRUITING","2025-09-23",{"date":61,"type":31},"2025-09-29",{"date":63,"type":31},"2022-03-15",{"date":65,"type":20},"2037-03",{"name":37,"class":38},1,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":48,"phases":4,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":80,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":67},"100505619","clinical-utility-and-gait-analysis-of-nextar-system-aus-100505619","NCT05863741","Clinical Utility and Gait Analysis of NextAR System AUS","Does Personalized Soft Tissue Balance Data Improve Outcomes in Patients Undergoing Medially Stabilized Knee Arthroplasty? A Prospective, Randomized Study Investigating the Clinical Utility of the NextAR Navigation System (NextAR).","Inclusion Criteria:\n\n* End-stage osteoarthritis of the knee suitable for total knee arthroplasty.\n* Aged over 18 years.\n\nExclusion Criteria:\n\n* Unsuitable for TKR due to chronic infection, medical disease, inability to consent, inability to attend for post-operative follow-up, significant psychiatric issues, substance abuse issues\n* Previous reconstructive\u002Ffracture\u002Farthroplasty surgery on affected knee\n* Active inflammation arthropathy\n* Significant extra articular deformity\n* Morbidly Obese (BMI \\>40)\n* Pregnant women",{"count":76,"type":20},100,"This study titled \"Does Personalised Soft Tissue Balance Data Improve Outcomes in Patients Undergoing Medially Stabilised Arthroplasty? A Prospective, Randomised Study Investigating the Clinical Utility of the NextAR navigation system (NextAR)\" is a randomised, single blinded, prospective cohort study with the primary aim determine the clinical utility of the NextAR system data in providing soft tissue balance patterns to enable prosthesis implants to resemble more native knee alignment.",[79],"Total Knee Arthroplasty",{"date":61,"type":31},{"date":82,"type":31},"2022-05-15",{"date":84,"type":20},"2026-05",{"name":37,"class":38},{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":93,"enrollmentInfo":94,"targetDuration":4,"studyType":48,"phases":4,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":100,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":67},"100502179","multicenter-mpact-dm-france-100502179","NCT05818891","Multicenter Mpact DM France","Prospective, Multicenter, Non-Controlled, Non-Randomized, Open-Label Study To Evaluate The Efficacy And Performance Of The Mpact® Dual Mobility Hemispheric Cup","Inclusion Criteria:\n\n1. Patient with a disease that meets the indications for use of Medacta implants (according to the instructions for use)\n2. Patient eligible for first-line total hip replacement\n3. Patient between 18 and 80 years of age\n4. Patient covered by the Social Security system or an equivalent protection plan\n5. Patient who is capable, in the opinion of the investigator, of fulfilling the requirements of the study\n\nExclusion Criteria:\n\n1. Patient requiring a transplant\n2. Patient with progressive local or systemic infection\n3. Patient with muscle loss, neuromuscular disease, or vascular impairment of the affected limb making surgery unwarranted\n4. Patient with known medical problems that may compromise independent recovery of mobility\n5. Patient with a BMI greater than 40 kg\u002Fm².\n6. Patient with major cognitive problems that do not allow a good understanding of the study requirements\n7. Patient living in a geographical area that does not allow the study follow-up\n8. Patient participating in interventional research.\n9. Minor patient\n10. Protected adult patient\n11. Vulnerable person according to article L1121-6 of the Public Health Code\n12. Pregnant or nursing woman.","80 Years",{"count":95,"type":20},600,"The primary objective of the study is to evaluate the 10-year performance of the MPACT DM cup in the treatment of patients requiring total hip arthroplasty.\n\nThe primary endpoint is the 10-year life span of the prosthesis according to the Kaplan Meier curve.",[98,99],"Total Hip Arthroplasty","Survival, Prosthesis",{"date":61,"type":31},{"date":102,"type":31},"2018-04-05",{"date":104,"type":20},"2031-04",{"name":37,"class":38},{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":93,"enrollmentInfo":113,"targetDuration":4,"studyType":48,"phases":4,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},"100474595","the-medacta-gmk-spherika-post-marketing-surveillance-study-100474595","NCT05459948","The Medacta GMK SpheriKA Post-Marketing Surveillance Study","Medacta GMK® SpheriKA and Kinematic Alignment Technique Multicenter, Post-Market Outcome Study","Inclusion Criteria:\n\n* Patients willing to sign the informed consent.\n* Patients able to comply with follow-up requirements, including postoperative weight-bearing restrictions and self-evaluations.\n* Patients 18 - 80 years of age at the time of surgery.\n* Patients requiring a primary total knee replacement (on label use).\n* Patients with intact collateral ligaments.\n\nExclusion Criteria:\n\n* Patients with inflammatory arthritis.\n* Morbidly obese patients, with a body mass index (BMI) \\> 40.\n* Patients with a history of total or unicompartmental reconstruction of the affected joint.\n* Patients that have had a high tibial osteotomy or femoral osteotomy.\n* Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.\n* Patients with a systemic or metabolic disorder leading to progressive bone deterioration.\n* Patients that are immunologically compromised or receiving chronic steroids (\\> 30 days).\n* Patients whose bone stock is compromised due to disease or infection, unable to provide adequate support and\u002For fixation to the prosthesis.\n* Patients with an active or suspected latent infection in or surrounding the knee joint.\n* Pregnant or breastfeeding women.",{"count":114,"type":20},281,"This is a Post-Marketing Surveillance of GMK SpheriKA knee stem prosthesis.",[117,118],"Arthropathy","Knee Replacement",{"date":61,"type":31},{"date":121,"type":31},"2022-07-30",{"date":123,"type":20},"2035-05",{"name":37,"class":38},4,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":133,"enrollmentInfo":134,"targetDuration":4,"studyType":48,"phases":4,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":143,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":125},"100266486","the-medacta-international-sms-post-marketing-surveillance-study-100266486","NCT02748408","The Medacta International SMS Post-Marketing Surveillance Study","The Medacta SMS Femoral Stem Component. A Multi-National, Multi-Centre, Clinical Surveillance Study","Inclusion Criteria:\n\n* Individuals with a severely painful and\u002For disabling hip joint with osteoarthritis, traumatic arthritis or developmental dysplasia of the hip or avascular necrosis of the femoral head.\n* In order to take part in this study, all study participants must be between the ages of 18 and 75 years of age, at the time of surgery.\n* Scheduled for a primary total hip replacement.\n\nExclusion Criteria:\n\n* Active infection\n* Pregnancy\n* Mental illness where the known condition is likely to compromise the patient's ability to consent, affect the patient's assessment of their progress or complete the 10 year cycle of follow-up appointments and reviews\n* Grossly distorted anatomy (surgeon's discretion)\n* Osteomalacia where uncemented implant fixation is contraindicated\n* Active rheumatoid arthritis.\n* Osteoporosis\n* Metabolic disorders which may impair bone formation where uncemented implant fixation is contraindicated\n* Muscular atrophy or neuromuscular disease\n* Allergy to implant material\n* Any patient who cannot or will not provide informed consent for participation in the study\n* Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems","75 Years",{"count":135,"type":20},550,"This is a Post-Marketing Surveillance of SMS femoral stem prosthesis.",[138,139,140,141,142],"Arthrosis","Traumatic Arthritis","Rheumatoid Polyarthritis","Congenital Hip Dysplasia","Avascular Necrosis of the Femoral Head",{"date":61,"type":31},{"date":145,"type":4},"2015-07",{"date":147,"type":20},"2032-07",{"name":37,"class":38},{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":156,"enrollmentInfo":157,"targetDuration":4,"studyType":48,"phases":4,"briefSummary":159,"conditions":160,"keywords":163,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":67},"100575701","clinical-and-radiological-outcomes-of-the-romax-hip-resurfacing-system-100575701","NCT06775704","Clinical and Radiological Outcomes of the ROMAX Hip Resurfacing System","Résultats Cliniques et Radiologiques du Dispositif de resurfaçage de Hanche ROMAXTM Medacta","Inclusion Criteria:\n\n* Patients eligible for hip resurfacing, suitable for the implantation of a Medacta ROMAX hip resurfacing system according to the manufacturer's defined indication for use.\n* Aged between 18 and 65 years at the time of surgery.\n* Ability and willingness to provide written informed consent for participation.\n\nExclusion Criteria:\n\n* Active infection\n* BMI \\> 40\n* Mental illness, when the known pathology is likely to compromise the patient's ability to consent, affect the patient's assessment of their progress, or complete follow-up appointments and exams.\n* Significantly deformed anatomy (at the surgeon's discretion)\n* Osteomalacia where the fixation of an uncemented implant is contraindicated\n* Active rheumatoid arthritis\n* Osteoporosis\n* Metabolic disorders likely to impair bone formation and for which the fixation of an uncemented implant is contraindicated\n* Muscle atrophy or neuromuscular disease\n* Known allergy or hypersensitivity to the implant material\n* Any patient who cannot or does not wish to give informed consent to participate in the study\n* Patients whose chances of regaining independent mobility would be compromised by known concomitant medical issues.","65 Years",{"count":158,"type":20},150,"The goal of this observational study is to collect clinical and radiological data to monitor the safety and performance of the ROMAX hip resurfacing system. The main parameter that will be measured is the rate of revisions at 10 years.",[161,162],"Arthritis (Hip)","Hip Dysplasia, Congenital",[164],"resurfacing","2025-09-22",{"date":167,"type":31},"2025-09-25",{"date":169,"type":31},"2025-07-14",{"date":171,"type":20},"2037-04-01",{"name":37,"class":38},{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":21,"phases":182,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":67},"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":181,"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.",[185,139,55],"Arthritis","2025-05-07",{"date":188,"type":31},"2025-05-11",{"date":190,"type":31},"2022-12-06",{"date":192,"type":20},"2027-12-06",{"name":37,"class":38},{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":21,"phases":202,"briefSummary":203,"conditions":204,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":214},"100444040","mirror-medacta-shoulder-system-pivotal-trial-100444040","NCT05062252","Mirror Medacta Shoulder System Pivotal Trial","Multicentric, Prospective, Comparative Trial to Assess the Efficacy and Safety of an Anatomic Total Shoulder System.","Inclusion Criteria:\n\n* Age ≥ 18 yr\n* Clinical indication for anatomic primary total shoulder replacement due to osteoarthritis and\u002For posttraumatic arthritis\n* Willingness and ability to comply with study protocol\n\nExclusion Criteria:\n\n* Medical condition or balance impairment that could lead to falls\n* Prior rotator cuff surgery\n* Cuff tear arthropathy\u002Finsufficient rotator cuff\n* Insufficient bone quality which may affect the stability of the implant\n* Neuromuscular compromise of shoulder or other disabilities affecting the maximum functional outcomes\n* Weight bearing shoulder due to wheel chair, crutches, rollator at the time of operation\n* Active metastatic or neoplastic disease at the shoulder joint\n* Chemotherapy treatment\u002Fradiotherapy within 6 mo before surgery\n* \\>5 mg\u002Fday of corticosteroids, excluding inhalers, within 3 years before surgery\n* Pregnancy or plan to become pregnant during study period\n* Inability to understand study or a history of noncompliance with medical advice\n* Alcohol or drug abuse\n* Current enrollment in any clinical research study that might interfere with this study\n* Metal allergies or sensitivity.\n* Previous or current infection at or near the site of implantation.\n* Current distant or systemic infection\n* Patient, whose infomed consent form should be taken in an emergency situation\n* ONLY for women of childbearing age: a positive pregnancy test (urine \u002F blood)",{"count":76,"type":20},[23],"The purpose of this study is to demonstrate safety and efficacy of the Mirror Medacta Shoulder System in total shoulder arthroplasty.",[205,206],"Arthritis Shoulder","Post-traumatic Arthrosis of Other Joints, Upper Arm",{"date":208,"type":31},"2025-05-08",{"date":210,"type":31},"2022-01-05",{"date":212,"type":20},"2027-12-30",{"name":37,"class":38},2,{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":133,"enrollmentInfo":222,"targetDuration":4,"studyType":48,"phases":4,"briefSummary":224,"conditions":225,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":234},"100573638","mpact-3d-metal-monolit-study-100573638","NCT06748885","Mpact 3D Metal Monolit Study","Prospective, Multicentre, Non-randomised, Open Study Evaluating the Efficacy and Fixation of the Mpact 3D Metal Monolit Cup","Inclusion Criteria:\n\n1. Patient with a disease that corresponds to the indications for use of Medacta implants (according to the instructions for use)\n2. Patient eligible for primary total hip arthroplasty\n3. Patient aged between 18 and 75 years\n4. Patient covered by the French Social Security system or an equivalent protection scheme.\n5. Patient able, in the investigator's opinion, to comply with the requirements of the study.\n\nExclusion Criteria:\n\n1. Patient suffering from inflammatory arthritis\n2. Previously operated hip\n3. Patient requiring a transplant\n4. Hip tumour involved\n5. Patient with progressive local or systemic infection\n6. Severe acetabular dysplasia\n7. Patient with muscle loss, neuromuscular disease or vascular impairment of the affected limb.\n\n4\\. Patient with known medical problems that may compromise independent recovery of mobility 5. Patient with a BMI greater than 40 kg\u002Fm². 6. Patient with major cognitive impairment that prevents him\u002Fher from fully understanding the requirements of the study 7. Patient living in a geographical area where study follow-up is not possible. 8. Patient taking part in interventional research 9. Minor patient 10. Protected adult patient 11. Vulnerable person according to article L1121-6 of the Public Health Code",{"count":223,"type":20},88,"Total hip arthroplasty (THA) is one of the most common operations performed in orthopaedics to improve a patient's quality of life.\n\nSurgeons are constantly seeking to improve all aspects of care related to this procedure, whether it be improving implant technology, improving instrumentation or the technique involved in performing the procedure.\n\nIn recent years, a new porous titanium coating has been introduced to promote good osseointegration of uncemented cups. High friction torque and a feeling of immediate anchorage provide excellent primary stability, while high porosity ensures bone growth providing secondary stability. With higher porosity than standard coatings, a greater volume of bone can be present in the porous surface, giving a proportional increase in force at the interface. he Mpact 3D Metal Monolith cup has been designed to provide greater range of motion and improved joint stability, with a reduced risk of dislocation. It is an innovative design that improves stability and provides a favourable environment for long-term biological metal-bone fixation.\n\nThe current study aims to collect clinical and radiological data to assess the function of the operated hip and the stability of the Mpact 3D Metal Monolith cup at 2 years and survival at 5 years for the treatment of patients requiring hip arthroplasty.",[26],"2024-12-23",{"date":228,"type":31},"2024-12-27",{"date":230,"type":31},"2024-02-28",{"date":232,"type":20},"2030-12",{"name":37,"class":38},3,{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":242,"enrollmentInfo":243,"targetDuration":4,"studyType":48,"phases":4,"briefSummary":245,"conditions":246,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":67},"100565329","multicentre-sms-study---fr-100565329","NCT06640764","Multicentre SMS Study - FR","Étude Prospective, Multicentrique, Non contrôlée, Non randomisée, Ouverte évaluant la Performance et la stabilité de l'Implant fémoral Non cimenté SMS","Inclusion Criteria:\n\n* Patient suffering from a severely painful and\u002For disabling hip joint due to osteoarthritis, traumatic arthritis, developmental dysplasia of the hip, or avascular necrosis of the femoral head, and requiring a total hip replacement.\n* Patient who will receive a Medacta SMS femoral stem.\n* Patient agrees to comply with the study requirements.\n* Patient has signed the consent form.\n* Patient is affiliated with a social security system.\n* Patient aged 18 to 75 years\n\nExclusion Criteria:\n\n* Participation in biomedical research.\n* Minor patient.\n* Protected adult patient.\n* Vulnerable individuals as defined by Article L1121-6 of the Public Health Code.\n* Pregnant or breastfeeding women.\n* Patient unable to express their non-opposition.\n* Patient refusing the collection of their personal data.\n* Acute, systemic, or chronic infection. Skeletal immaturity.\n* Grossly deformed anatomy (at the surgeon's discretion).\n* Osteomalacia for which the fixation of an uncemented implant is contraindicated.\n* Patient suffering from active rheumatoid arthritis or osteoporosis.\n* Patient with metabolic disorders likely to impair bone formation when the fixation of an uncemented implant is contraindicated.\n* Patient suffering from muscle atrophy or neuromuscular disease.\n* Patient with an allergy to the implant material.\n* Any patient who cannot or does not wish to give their informed consent to participate in the study.\n* Patient whose prospects of regaining independent mobility would be compromised by known coexisting medical problems.\n* Any contraindication mentioned in the instructions for use of the investigational medical device.","85 Years",{"count":244,"type":20},260,"Prospective, multicentre, non controled, non randomised, clinical study to assess the performance and the stability of SMS femoral stem",[247,248,249,250],"Dysplasia of Hip Joint","Hip Osteoarthritis","Traumatic Arthritis of Hip","Avascular Necrosis of Femur Head","2024-10-11",{"date":253,"type":31},"2024-10-15",{"date":255,"type":31},"2024-09-01",{"date":257,"type":20},"2037-09-01",{"name":37,"class":38},{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":133,"enrollmentInfo":266,"targetDuration":4,"studyType":48,"phases":4,"briefSummary":268,"conditions":269,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":67},"100499600","a-post-market-surveillance-study-about-the-monocer-cup-100499600","NCT05785364","A Post Market Surveillance Study About the MONOCER Cup","Monocer Cup: Open, Prospective, Multicentric, Non Randomised Observational Study","Inclusion Criteria:\n\n1. Patients undergoing total hip arthroplasty who will receive the Mpact 3D Metal MonoCER acetabular component according to the instructions for use\n2. Patients who have signed the informed consent to participate in the study\n\nExclusion Criteria:\n\n1. Minor patients, patients over 75 years of age at the time of primary surgery;\n2. Any patient who is unable or unwilling to give informed consent to participate in the study.",{"count":267,"type":20},250,"Over the years, the use of large diameter femoral heads has become increasingly common in orthopaedics due to the decreased risk of dislocation due to increased jumping distance and range of motion. The history of total hip arthroplasty does not favour large diameter heads, especially as conventional polyethylene has a high risk of wear. The development of hard-on-hard bearings (CoC) with a second generation ceramic material and the introduction of cross-linked PE have led to the reintroduction of this concept. The Mpact 3D Metal MonoCER cup was developed to offer the advantages of accommodating large diameter heads with an external metal cup with a pre-assembled system that avoids the surgical step of insert-cotile coupling.",[98],"2024-04-30",{"date":272,"type":31},"2024-05-01",{"date":274,"type":31},"2022-01-25",{"date":276,"type":20},"2050-02-01",{"name":37,"class":38},{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":48,"phases":4,"briefSummary":287,"conditions":288,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":289,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":67},"100424035","gmk-sphere-tinb-total-knee-arthroplasty-pms-study-100424035","NCT04801654","GMK Sphere TiNb Total Knee Arthroplasty PMS Study","A Monocentric, Prospective Clinical Survey on Long Term Performance of GMK Sphere Total Knee Arthroplasty","Inclusion Criteria:\n\n* Those older than 18 years old at the surgery time\n* those suitable to undergo to a primary total knee arthroplasty for whom the GMK Sphere TiNb coated device will be implanted (according to the label indication\u002Fcontraindications)\n* Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to patient's surgery\n\nExclusion Criteria:\n\n* Those patients with metal implants containing Co, Cr and \u002F or Ni\n* Those patients who have had environmental or occupational exposure to toxic metals such as Co, Cr and \u002F or Ni (solvents, industrial paints, welders)\n* Those whose mental conditions may compromise their ability to provide informed consent to study participation, ability to complete questionnaires or complete 10-year follow-ups\n* Those unable to give their consent to participate in the study or who do not want to participate\n* Any condition not mentioned in inclusion criteria.",{"count":286,"type":20},155,"Total knee arthroplasty (TKA) is one of the success stories of modern surgery, providing high patient satisfaction outcomes. Total knee prostheses are generally composed by a femoral component articulating on a polyethylene insert and a tibial tray.\n\nRecently there has been particular attention on the component material; traditionally femoral components are made of cobalt alloys while tibial baseplates are made, in the great majority of cases, of metallic materials, but also polyethylene versions are available. There has been a degree of acceptance in some countries that metal related pathology may exist as demonstrated by the Australian Arthroplasty register where metal hypersensitivity was reported as the fifth most common cause for revision hip arthroplasty 2012 report, making up for 5.9% of all revisions. The wording was subsequently changed from \"metal sensitivity\" to \"metal related pathology\" in the 2014 report with 0.5% of all revision total hip arthroplasties (THA) associated with this term. The same change in terminology was used for TKA with metal sensitivity as a cause for revision in 1.3% of revisions in 2012 and in 2014, 1.8% of revision TKAs attributed to \"metal related pathology\" . The overall revision rate was 3.45% after 10 years in 396.472 TKAs, suggesting a revision rate of 0.06-0.32% secondary to metal or cement allergies. Up to today there is no question that metallic implants may generate wear debris that cause local reactions. This local reaction is not dose related nor predictable and therefore not purely due to the toxic effect of the debris but possibly due to an immunological host process. Hypersensitivity to metal undoubtedly exists but it cannot be stated at the moment to be an allergic reaction. To prevent issues arising due to metal related pathology, alternative solutions to conventional chrome cobalt material have been proposed, for example ceramic component or implant coating. In particular, TiNbN coating has been proposed by most companies thanks to its excellent biological properties. Preclinical studies have showed a high scratch resistance and low coefficient of friction, more resistance to fretting corrosion, reduction of wear, lower ion release rates and low fatigue cycle, as described in the review of Hove. Clinically, cohort of studies of TiN-coated implants showed an overall survival exceeding 90% with a follow-up of 15 to 77 months and good clinical outcomes. No reports of adverse effects related to TiN coating of CoCrMo knee implants have been showed. There are few studies that compared TiN-coated implants with the same uncoated version. Thienpont, comparing TiN-coated and uncoated CoCrMo implants, showed similar clinical and radiological outcomes at short-term follow up in both patients groups .\n\nOverall we can conclude that in literature no adverse events have been reported concerning the TiNbN coating and in particular it has been showed that the coating doesn't not affect the performance of the device if compared with the same uncoated version.\n\nThe aim of this study is to evaluate the long term clinical and radiological performance of GMK Sphere total knee component, coated version.",[79],{"date":272,"type":31},{"date":291,"type":31},"2020-02-05",{"date":293,"type":20},"2033-12-05",{"name":37,"class":38},{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":133,"enrollmentInfo":302,"targetDuration":4,"studyType":48,"phases":4,"briefSummary":304,"conditions":305,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":306,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":67},"100424037","mpact-3d-metal-cup-pms-100424037","NCT04801680","Mpact 3D Metal Cup PMS","A Multicentric, Prospective Clinical Survey on Long Term Performance of an Acetabular Component in Primary Total Hip Arthroplasty","Inclusion Criteria:\n\n* Those suffering from hip primary arthrosis, post-traumatic arthrosis, hip dysplasia or avascular necrosis of femoral head, rheumatic arthrosis\n* Those aged between 18 and 75 years old at the surgery time\n* those suitable to undergo to a primary total hip arthroplasty for whom the Mpact 3D Metal cup will be implanted (according to the label indication\u002Fcontraindications)\n* Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to patient's surgery\n\nExclusion Criteria:\n\n* Those with acute or chronic infection\n* Those whose mental conditions may compromise their ability to provide informed consent to study participation, ability to complete questionnaires or complete 10-year follow-ups.\n* Those suffered by severe deformation, at the discretion of surgeon\n* Those suffered by osteoporosis\n* Those with metabolic disorders that may involve bone metabolism for which cementless implants are contraindicated\n* Those suffered by muscular atrophy or neuromuscular disease\n* Those allergic to medical device material previewed for the surgery\n* Those unable to give their consent to participate in the study or who do not want to participate\n* Those whose functional recovery is compromised by",{"count":303,"type":20},500,"Cementless fixation, with or without screw augmentation, has evolved during the past few decades as the preferred method for acetabular reconstruction. Although major improvements have been recorded with regard to clinical outcomes and survivorship, acetabular component loosening remains among the most common causes of failure and revision. Patient age, poor bone quality and conditions, such as osteonecrosis and dysplasia, have been observed to influence negatively long-term clinical results.\n\nInitial stability is fundamental for survivorship of cementless cups. Prerequisites to achieve durable cementless cup fixation are close contact with viable native bone, primary mechanical stability and secondary bone integration. Press-fit techniques provide optimal conditions for bone ingrowth and fixation but research focused on cup material in order to improve primary stability. Pore size, bone-implant apposition, and material properties all influence bone ingrowth and long-term stability.\n\nBiological ingrowth surfaces have become a standard prosthetic element in reconstructive hip surgery. A material's properties, three-dimensional architecture, and surface texture all play integral parts in its biological performance. Trabecular metal is an important new biomaterial that has been introduced to enhance the potential of biological ingrowth as well as provide a structural scaffold in cases of severe bone deficit. The continuity between the porous and solid parts has been specifically developed to overcome the limitations of the traditional porous coatings. In fact, the absence of an interface between the trabecular structure and the bulk material provides greater structural solidity and thus higher resistance to detachment and corrosion. Initial clinical applications have focused on bone restoration in tumor and salvage cases and in primary and revision reconstructive cases where the increased biological fixation would be of clinical benefit. However the bone ingrowth potential and mechanical integrity of this material offer exciting options for orthopedic reconstructive surgeons such as difficult THA cases, such as patients with high demands, subjects affected by severe hip conditions (i.e. osteonecrosis, dysplasia) or with extremely poor bone quality. Medacta Mpact 3D Metal cup, is an acetabular cup realized using the EBM (Electron Beam Melting) powder technology; this production method offers a high friction and scratch-fit feel for the initial stability, without the need of any additional coating. Moreover the 3D Metal structure creates a favorable environment for bone thus providing secondary fixation.\n\nThe aim of this study is to evaluate the long term clinical and radiological performance of MPact 3D Metal acetabular component.",[98],{"date":272,"type":31},{"date":308,"type":31},"2019-11-07",{"date":310,"type":20},"2032-12-07",{"name":37,"class":38},{"id":313,"slug":314,"hasResults":11,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":319,"targetDuration":4,"studyType":48,"phases":4,"briefSummary":320,"conditions":321,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":234},"100398002","m-ars-acl-post-marketing-surveillance-study-100398002","NCT04462458","M-ARS ACL Post-marketing Surveillance Study","Clinical and Radiological Outcomes of M-ARS ACL","Inclusion Criteria:\n\n* Patients older than 18 years\n* Patients with ACL rupture requiring ACL reconstruction\n\nExclusion Criteria:\n\n* Patients with malignant diseases (at the time of surgery)\n* Patients with proven or suspected infections (at the time of surgery)\n* Patients with functional deficits of the affected extremity (at the time of surgery)\n* Patients with known incompatibility or allergy to products materials (at the time of surgery)",{"count":47,"type":20},"The goal of this study is to evaluate the performance of Medacta Anatomic Ribbon Surgery (M-ARS) in patients requiring anterior cruciate ligament (ACL) reconstruction.\n\nThe main goal is to evaluate the survival rate of M-ARS ACL at 6 months post-operatively. The secondary goals are to assess the survival rate, clinical and functional outcomes, the quality of life, and the rate of complications at 1 month, 1 year and 2 years post-operatively.",[322],"Anterior Cruciate Ligament (ACL) Reconstruction","2023-03-10",{"date":325,"type":31},"2023-03-13",{"date":327,"type":31},"2022-07-01",{"date":329,"type":20},"2027-01",{"name":37,"class":38},""]