[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prosthesis-durability\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prosthesis-durability":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,40,66,103,127,143,180,208],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100540761","evaluation-of-the-clinical-outcomes-of-the-total-knee-ps-prosthesis-implanted-with-the-use-of-inertial-sensors-100540761",false,"NCT06321042","Evaluation of the Clinical Outcomes of the Total Knee ps Prosthesis Implanted With the Use of Inertial Sensors","Evaluation of the Clinical Outcomes of the Total Knee Prosthesis With Posterior Stabilization Implanted With the Use of Inertial Sensors","SYMPHO-EM","Inclusion Criteria:\n\n1. Male and female subjects 50 years of age or older and less than 85 years of age (\\>50 and \\\u003C85 years) who are candidates for primary cemented total knee replacement based on physical examination and medical history, including diagnosis of severe knee pain and disability due to at least one of the following causes:\n\n   * to. Primary or secondary osteoarthritis\n   * b. Collagen disorders and\u002For avascular necrosis of femoral condyle\n   * c. Moderate valgus, varus or flexion deformities (HKA between ± 10°, flexion contracture \\\u003C10°) -\n2. Patients consent and able to complete scheduled study procedures and follow-up assessments.\n3. Patients informed about the nature of the study who signed the \"informed consent\" approved by the ethics committee.\n\nExclusion Criteria:\n\n* Simultaneous participation in other studies\n* Patients not capable of understanding and wanting and therefore unable to sign the informed consent\n* Patients who have already undergone hip or ankle arthroplasty, previous osteotomy, with severe axial deformities or suffering from rheumatoid arthritis, diabetes or neuromuscular diseases.","ALL","50 Years","85 Years",{"count":21,"type":22},40,"ESTIMATED","OBSERVATIONAL","evaluate the clinical outcome of the implantation of a specific primary TKA model implanted with the aid of inertial sensors for the execution of bone cuts through the administration of questionnaires for the calculation of clinical-functional scores;",[26],"Prosthesis Durability","RECRUITING","2026-04-20",{"date":30,"type":31},"2026-04-23","ACTUAL",{"date":33,"type":31},"2023-01-13",{"date":35,"type":22},"2027-03",{"name":37,"class":38},"Istituto Ortopedico Rizzoli","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":4},"100609486","abutment-analysis-of-metallic-denture-frameworks-in-mandibular-kenedy-class-iii-cases-100609486","NCT07215208","Abutment Analysis of Metallic Denture Frameworks in Mandibular Kenedy Class III Cases","Abutment Health and Occlusal Analysis of CAD-CAM and Conventional Metallic Partial Denture Framework in Mandibular Kenedy Class III Cases: A Randomized Cross Over Clinical Trial","Inclusion Criteria:\n\n* Patients with unilateral bounded saddles in the mandible (Kennedy class III).\n* Opposing dentition is fully intact or restored.\n* Sufficient inter-arch space.\n* Angle's class I maxilla-mandibular relationship.\n\nExclusion Criteria:\n\n* Periodontal affection of the abutment teeth.\n* Skeletal mal-relation.\n* Unmotivated patients to maintain adequate oral hygiene to follow up.\n* Patients with neuromuscular and Psychiatric disorders.\n* Systematic disease affecting bone and periodontal health.\n* Insufficient inter-arch space.\n* Patients with physical disabilities that could affect follow up.",true,{"count":49,"type":22},22,"INTERVENTIONAL",[52],"NA","This study is aimed to compare CAD\u002FCAM (digitally fabricated) metallic partial denture frameworks to conventionally fabricated metallic partial denture frameworks in mandibular Kennedy class-III arches in terms of abutment health and occlusal analysis",[55,26],"Occlusion","NOT_YET_RECRUITING","2025-10-02",{"date":59,"type":31},"2025-10-10",{"date":61,"type":22},"2025-10",{"date":63,"type":22},"2026-01",{"name":65,"class":38},"Cairo University",{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":50,"phases":75,"briefSummary":76,"conditions":77,"keywords":86,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":39},"100584966","tavr-the-impact-of-prothesis-positioning-on-valvular-and-coronary-hemodynamics-100584966","NCT06896227","TAVR: The Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics","Transcatheter Aortic Valve Implantation (TAVR): The Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics","Inclusion Criteria\n\n\\- Patients who have undergone transfemoral transcatheter aortic valve replacement (TAVR).\n\nExclusion Criteria\n\n* Any access route other than transfemoral.\n* Valve-in-valve procedures.\n* History of prior bioprosthetic valve implantation.\n* Presence of pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) system.\n* Diagnosis of liver cirrhosis.\n* Esophageal disorders, including but not limited to esophageal varices.\n* Thrombocytopenia or coagulation disorders.\n* Any medical or psychiatric condition (e.g., dementia, alcoholism, or substance abuse) that may impair the ability to provide informed consent or interfere with study procedures, including follow-up visits.",{"count":74,"type":22},100,[52],"The aim of this clinical study is to learn more about the effects of TAVR-prosthesis positioning on hemodynamics and the coronary arteries.\n\nThe main questions it aims to answer are:\n\n1. Does the cardiac magnetic resonance imaging and the echocardiography imaging provide an equivalent alternative to the computer tomography which is the state of the art in evaluating commissural alignment?\n2. What effect does the position of the valve on the annular level have, especially its symmetrical and commissural position, on valvular and aortic blood flow characteristics?\n3. What is the influence of symmetrical position and the presence of a commissural alignment on the coronary flow after transcatheter aortic valve replacement?",[78,79,80,81,82,83,26,84,85],"Transcatheter Aortic Valve Replacement","Transcatheter Aortic Valve Implantation","Commissural Alignment","Commissural Misalignment","Symmetry","Prothesis Positioning","Aortic Valve Stenosis","Aortic Valve Disease",[87,88,89,82,90,91,92,93],"TAVR","TAVI","Commissural alignment","Prothesis positioning","cMRI","4D Flow","TEE","2025-03-19",{"date":96,"type":31},"2025-03-26",{"date":98,"type":31},"2024-10-22",{"date":100,"type":22},"2025-12-31",{"name":102,"class":38},"Heinrich-Heine University, Duesseldorf",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":17,"minAge":110,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":126},"100444077","sebbin-round-anatomical-and-biconvex-gluteal-implants-100444077","NCT05062733","SEBBIN Round, Anatomical and Biconvex Gluteal Implants","Prospective Observational Study About SEBBIN Gluteal Implants","Inclusion Criteria:\n\n* The patient is a man or a woman ≥ 18 years old at the time of inclusion.\n* The patient is planned for a unilateral or bilateral gluteal implant placement with SEBBIN implants as per investigator decision\n* The patient has been informed of the study, has read the patient informed consent and provided consent for the study in writing.\n\nExclusion Criteria:\n\n* Patient implanted with silicone implants somewhere else in the body.\n* Patient candidate for implantation with custom-designed implants.\n* Participation in another interventional clinical study (participation into an observational study is permitted) with a medicinal product or a medical device in the 30 days prior to enrolment.","18 Years",{"count":112,"type":22},60,"This study is part of the clinical evaluation of SEBBIN silicone gel-filled gluteal implants, included in the technical file of the device. The aim of the study is to gather additional data about the safety and effectiveness of the device.",[115,26],"Complication","2024-10-30",{"date":118,"type":31},"2024-10-31",{"date":120,"type":31},"2021-11-20",{"date":122,"type":22},"2035-03",{"name":124,"class":125},"Groupe SEBBIN","INDUSTRY",2,{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":137,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":126},"100436838","sebbin-silicone-gel-filled-testicular-implants-100436838","NCT04968470","SEBBIN Silicone Gel-filled Testicular Implants","Prospective Observational Study About SEBBIN Silicone Gel-filled Testicular Implants","Inclusion Criteria:\n\n* The patient is an adult or a child at the time of implant placement with SEBBIN implant.\n* The patient is candidate to a unilateral or bilateral testicular implant placement with SEBBIN implant.\n* The patient has been informed of the study, has read the patient information letter and -provided oral consent.\n\nExclusion Criteria:\n\n* The patient has silicone implants somewhere else than in the scrotal sac.\n* The patient was diagnosed with one of the following pathologies:\n\n  * Systemic lupus erythematous, Sjogren syndrome, scleroderma, polymyositis, or any other connective tissue disease.\n  * Rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, or any other inflammatory arthritic disease.\n  * Arthritis, fibromyalgia, chronic fatigue syndrome, or any other mechanic or degenerative non-inflammatory rheumatic disease.\n* The patient has a pathology that could delay healing.\n* Custom-designed implants are used for surgery.",{"count":74,"type":22},"This study is part of the clinical evaluation of SEBBIN silicone gel-filled testicular implants, included in the technical file of the device. The aim of the study is to gather additional data about the safety and effectiveness of the device.",[115,26],{"date":118,"type":31},{"date":139,"type":31},"2021-03-16",{"date":141,"type":22},"2035-09",{"name":124,"class":125},{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":150,"minAge":110,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":153,"conditions":154,"keywords":159,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":39},"100565253","sexual-functioning-after-erection-prosthesis-placement-in-post-phalloplasty-transgender-persons-100565253","NCT06639776","Sexual Functioning After Erection Prosthesis Placement in Post Phalloplasty Transgender Persons","Sexual Functioning After Erection Prosthesis Placement in Post Phalloplasty Transgender Persons: a Retrospective Cohort","Inclusion Criteria:\n\n* Patient and partner age ≥ 18 years.\n* Transgender or gender non-conforming individuals diagnosed according to the DSM-5 diagnostic criteria for gender dysphoria.\n* Patients have undergone phalloplasty as a form of genital gender affirming surgery (any type of flap combination or technique is allowed).\n* Erection prosthesis placement ≥ 6 months after phalloplasty, performed at the Ghent University Hospital. Any type of prosthesis is allowed.\n* Patient has a functional erectile prosthesis at the time of the study. Number of erectile prosthesis is not relevant for inclusion.\n* Patient is Dutch, English or French speaking.\n* Voluntary signed and written consent by patient and their optional partner.\n\nExclusion Criteria:\n\n* Patient age \\< 18 years.\n* Cisgender patients treated with phalloplasty and\u002For erection prosthesis for various reasons.\n* The erection prosthesis has been explanted or the current prosthesis is nonfunctional at time of data assessment.\n* Erection prosthesis placement \\< 6 months before study start will be excluded.","FEMALE",{"count":152,"type":22},150,"This study aims to explore sexual satisfaction among transgender men and their partners following the placement of erectile prostheses after phalloplasty. While phalloplasty can create a neophallus, the lack of natural erectile tissue often necessitates the use of erectile aids, including internal prostheses. However, these prostheses, originally designed for cisgender men, face challenges when used in transgender patients, such as higher risks of complications, infections, and mechanical failures. Despite these issues, some studies report high patient satisfaction, though partner satisfaction rates are significantly lower. The study will use validated and non-validated questionnaires to assess satisfaction with various types of erectile prostheses, addressing the gap in understanding how these devices impact the sexual and relational functioning of both transgender men and their partners. These questionnaires will be provided to all included patients that are minimum 6 months after placement of an internal erection prosthesis and have a functional erection prosthesis in place",[155,156,26,157,158],"Transgenderism","Erectile Dysfunction","Gender Dysphoria","Sexual Dysfunction",[160,161,162,163,164,165,166,167,168,169,170],"Gender dysphoria","Transgender","Phalloplasty","Erectile dysfunction","Sexual function","Erection prosthesis","Penile epithesis","Medical device","Penile splint","Genital reconstruction","Patient Reported Outcome Measures (PROMs)","2024-10-11",{"date":173,"type":31},"2024-10-15",{"date":175,"type":31},"2024-07-15",{"date":177,"type":22},"2025-07-31",{"name":179,"class":38},"University Hospital, Ghent",{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":17,"minAge":186,"maxAge":187,"enrollmentInfo":188,"targetDuration":189,"studyType":23,"phases":4,"briefSummary":190,"conditions":191,"keywords":198,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":39},"100446775","prospective-observational-study-on-sebbin-silicone-gel-filled-testicular-implants-100446775","NCT05097820","Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants","Inclusion Criteria:\n\n* The patient is an adult or a child at the time of testicular implant placement.\n* The patient is a candidate to unilateral or bilateral testicular implant placement.\n* The patient has been informed of the study, has read the patient information letter and provided oral and written consent.\n* If the patient is of French nationality, he\u002Fshe must be affiliated to the French Social Security.\n\nExclusion Criteria:\n\n* The patient has silicone implants somewhere else than in the scrotal sac (except for a penile prosthesis).\n* The patient was diagnosed with one of the following pathologies:\n\nSystemic lupus erythematous, Sjogren syndrome, scleroderma, polymyositis, or any other connective tissue disease.\n\nRheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, or any other inflammatory arthritic disease.\n\nArthritis, fibromyalgia, chronic fatigue syndrome, or any other mechanic or degenerative non-inflammatory rheumatic disease.\n\nThe patient has any other underlying condition that could delay healing.\n\n\\- Custom-designed implants are used for surgery.","0 Years","110 Years",{"count":74,"type":22},"2 Years","To analyze the short and long term postoperative clinical outcome and patient satisfaction of silicone gel-filled testicular implants.",[192,193,157,194,195,196,197,26],"Testicular Cancer","Testicular Torsion","Undescended Testes","Orchitis","Testicular Agenesis","Testicular Atrophy",[199],"testicular prosthesis","2024-09-05",{"date":202,"type":31},"2024-09-19",{"date":204,"type":31},"2021-02-05",{"date":206,"type":22},"2030-12-31",{"name":179,"class":38},{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":47,"sex":150,"minAge":110,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":50,"phases":216,"briefSummary":217,"conditions":218,"keywords":219,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":227,"locationsCount":126},"100507143","epithesis-versus-prosthesis-in-post-phalloplasty-transgender-patients-100507143","NCT05883553","Epithesis Versus Prosthesis in Post-phalloplasty Transgender Patients.","EROS","Inclusion Criteria:\n\n* Transgender or gender non-conforming individuals diagnosed according to the DSM-5 diagnostic criteria for gender dysphoria.\n* Patients have undergone phalloplasty as a form of genital gender affirming surgery.\n* ≥ 1 year after phalloplasty (any type of flap combination is allowed), performed at the Ghent University Hospital or Amsterdam UMC.\n* ≥ 3 months after coronaplasty and having reasonably pronounced coronal ridge, as defined by the surgeons' expert opinion (This criterion is only obligatory in the eptithesis group, not in the prosthesis group).\n* Anatomic penile length and girth as defined by the surgeons' expert opinion.\n* Absence of urethral stricture or other structural problem resulting in voiding dysfunction.\n* Normal uroflowmetry and post-void residue\n* Regain of at least minimal protective sensation up to the tip of the phallus as defined by Semmes-Weinstein monofilament testing.\n* Established (primary) sexual relationship with partner who is willing to take part in the study.\n* Both patient and partner have interest in penetrative sexual intercourse.\n* Patient is unable to penetrate the partner (anal or vaginal) adequately sexually without the aid of supportive measures (condom, taping, penile sleeve, penile epithesis or any other measure defined as supportive by the investigators).\n* Fit and eligible for erection prosthesis surgery, based on the surgeons' expert opinion.\n* No history of erection prosthesis surgery.\n* No interest in or fear of prosthesis surgery making this option obsolete (This criterion is only obligatory in the eptithesis group, not in the prosthesis group)\n* Treatment naïve in the use of the Elatortm or Erektortm epithesis.\n* Voluntarily signed written informed consent according to the rules of Good Clinical Practice (Declaration of Helsinki) and national regulations.\n\nExclusion Criteria:\n\n* Cisgender patients treated with phalloplasty various reasons.\n* Post-metoidioplasty patients (metoidioplasty as step-up to performed phalloplasty is allowed).\n* Absence of coronaplasty or coronaplasty performed \\\u003C 3 months ago or coronaplasty did not leave sufficiently pronounced coronal ridge as defined by the surgeons' expert opinion (This criterion is only obligatory in the epithesis group, not in the prosthesis group)\n* Penile dimensions are not anatomic (e.g. too small or too large).\n* Underlying LUTDs requiring further investigation and\u002For treatment.\n* Inadequate protective sensation in the penis.\n* No established (sexual) partner and\u002For partner is not willing to take part in the study.\n* Patient and\u002For partner have no interest in penetrative sexual intercourse.",{"count":21,"type":22},[52],"Transgender and gender diverse (TGD) individuals most often choose for phalloplasty as a means to create masculine external genitalia. The neophallus created in phalloplasty is usually insufficient for penetrative sexual intercourse due to the lack of erectile structures. Therefore, implantation of an internal erectile prosthesis or use of an external device or epithesis is required.\n\nInternal prostheses are the main method for attaining penile rigidity after phalloplasty, but they carry a high risk of complications. Previous research has shown that up to 22% of prostheses for cisgender men were explanted due to various reasons, including infection, erosion, and malfunction within 20 months. The lack of reliable and durable erectile devices leads to a large proportion of patients either choosing phalloplasty but never going for the placement of an erectile prosthesis or completely abandoning the idea of GGAS under the form of phalloplasty. Secondarily, TGD individuals may be concerned about complication rates and likely need for additional surgeries associated with penile implant surgery. Therefore, alternative options for transgender and gender non-conforming patients after phalloplasty are needed. These alternatives may be surgical or non-surgical.\n\nExternal penile epitheses or penile splints were originally designed for cisgender men with erectile dysfunction but have been used experimentally by post-phalloplasty transgender men. While there is no data on the usability and durability of penile epitheses in a TGD population, they may be a viable alternative to an internal penile prosthesis after phalloplasty. Penile lifters or splints, marketed as ElatorTM or ErektorTM, are commercially available and consist of two rigid rings connected by rigid metal rods. The biggest of two rings is placed around the base of the phallus, and the second ring is placed behind the coronal ridge. By connecting the rods to the ring at the base of the penis, tension and rigidity between the two rings is created, allowing the user to penetrate their partner and remove the device after intercourse.\n\nThe current study aims to extend the knowledge on these external devices by comparing them to the implantation of an internal penile prosthesis in post-phalloplasty transgender patients.",[155,156,26,157,158],[160,161,162,163,164,165,166,167,168,170,169,220],"Reconstructive urology","2024-08-02",{"date":223,"type":31},"2024-08-05",{"date":225,"type":31},"2023-05-17",{"date":100,"type":22},{"name":179,"class":38}]