[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prosthesis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prosthesis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,75,104],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100572784","clinical-and-functional-assessment-of-patients-with-transfemoral-amputation-treated-with-osteointegrated-implant-100572784",false,"NCT06737770","Clinical and Functional Assessment of Patients With Transfemoral Amputation Treated With Osteointegrated Implant","OSTEO-OUTCOME","Inclusion Criteria:\n\n* Subjects of both sexes, aged between 18 and 65 years;\n* Subjects with unilateral transfemoral amputation, following trauma, tumor, infection, or congenital defect;\n* Subjects already scheduled for osteointegrated prosthesis surgery for amputation;\n* BMI \\\u003C 35 kg\u002Fm²;\n* Difficulty in using the traditional socket prosthesis (pain, reduced mobility, short residual limb, skin infections, ulcers, volume changes in the residual limb);\n* Subjects who have signed informed consent and reviewed the study information sheet.\n\nAbsolute exclusion criteria:\n\n* Peripheral vascular diseases;\n* Pregnancy;\n* Rheumatoid arthritis;\n* Neurological deficits;\n* Amputation of the contralateral limb;\n* Active infections;\n* Immunodeficiency;\n* Comorbidities\u002Fconcurrent disabilities, general or localized (Multiple Sclerosis, Parkinson's disease, muscle tone disorders, malignant neoplasms, etc.), that may interfere with the study;\n* Presence of uncontrolled psychiatric comorbidities;\n* Declared or evident cognitive deficits that would impair understanding of the tasks required (MMSE ≤ 24);\n* Insufficient degree of cooperation;\n* Length of the bone stump (measured from the lesser trochanter to the apex of the stump) less than 15 cm;\n* Previous radiotherapy on the amputated limb;\n* Ongoing chemotherapy treatments.\n\nRelative exclusion criteria:\n\n* Smoking;\n* Uncontrolled diabetes;\n* Previous infections;\n* Presence of additional joint prostheses on the same limb;\n* Osteoporosis with a T-score of -2.5 or lower.","ALL","18 Years","65 Years",{"count":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"NA","Limb amputation is a traumatic event that significantly reduces the ability to perform daily activities, impairs mobility, and lowers quality of life. In Italy, approximately 4 million people live with disabilities, with 1.2 million having motor disabilities. Among lower limb amputees (around 200,000), most are elderly, with amputations due to diabetic or vascular issues. Other groups include middle-aged adults (often victims of workplace accidents) and young individuals (victims of traffic accidents).\n\nPost-amputation rehabilitation mainly involves the use of prostheses, which, however, can cause skin problems due to the socket (the part that anchors the prosthesis to the residual limb). Among patients using a socket, 34-63% develop chronic skin issues and pain. Complications include excessive sweating, sores, abscesses, and irritation. Additionally, daily volume changes in the residual limb and long-term weight fluctuations further complicate the use of conventional prostheses.\n\nIn the last two decades, research groups, assisted by experienced surgeons, have worked to develop implant solutions that bypass the socket and address these issues. One such solution is osteointegrated prostheses, which use the principle of osteointegration to anchor the prosthesis directly to the bone of the residual limb. A metal stem is surgically inserted into the medullary canal of the residual limb and fixed through bone growth, establishing a direct connection between the amputated limb and the external prosthesis.\n\nOsteointegrated prostheses are widely accepted worldwide as a valid alternative to socket prostheses, especially for young and active individuals with transfemoral, transtibial, transhumeral, or transradial amputations not caused by vascular issues. The key benefit of osteointegration is the restoration of load alignment along the anatomical and mechanical axis, improving control of the residual limb during walking, as well as overall functional capacity and quality of life. Other advantages include greater stability, enhanced sitting comfort, a wider range of hip movement, faster attachment and detachment of the prosthesis, and improved body perception. Additionally, the direct contact between the metal stem and the bone generates sensory feedback (osteoperception), allowing the patient to better control the amputated limb by perceiving ground contact through vibrations transmitted to the bone. Osteointegration offers the only viable alternative for prosthetic use in patients with a short residual limb, where conventional socket prostheses would not be suitable.",[27,28,29],"Prosthesis","Lower Limb Amputation Knee","Amputation; Traumatic, Leg, Lower",[31],"Osseointegration","RECRUITING","2026-02-16",{"date":35,"type":36},"2026-02-17","ACTUAL",{"date":38,"type":36},"2025-01-31",{"date":40,"type":21},"2027-01",{"name":42,"class":43},"Istituto Ortopedico Rizzoli","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":55,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":44},"100622317","a-prospective-multicenter-clinical-study-on-the-efficacy-and-safety-of-the-zirconia-ceramic-hip-joint-prosthesis-system-after-its-market-launch-100622317","NCT07382050","A Prospective Multicenter Clinical Study on the Efficacy and Safety of the Zirconia Ceramic Hip Joint Prosthesis System After Its Market Launch","A Prospective Multicenter Clinical Study on the Efficacy and Safety of the Zirconia Ceramic Hip Joint Prosthesis System After Its Market launchM20251018","Inclusion Criteria:\n\n1. The patient's age ranges from 18 to 80 years old (inclusive), with no gender restrictions.\n2. The patient's bones have matured.\n3. The patient is indicated for hip replacement surgery\n4. The subjects participating in the study were undergoing hip replacement for the first time\n5. The subject or his\u002Fher guardian is willing and able to sign the informed consent form\n\nExclusion Criteria:\n\n1. There are contraindications for hip replacement surgery\n2. It is known that the patient has a history of allergy to one or more implant materials\n3. Pregnant or lactating women\n4. Hip dysplasia is classified into CROWE grades 3 and 4\n5. Those who are physically weak or unable to tolerate surgery due to other systemic diseases, as well as those with an expected lifespan of less than two years\n6. The reasons why other researchers believe that patients are not suitable for this study","80 Years",{"count":54,"type":21},290,"12 Months","OBSERVATIONAL","This study adopted a prospective, multi-center, single-group target value trial design to evaluate the safety and efficacy of the hip joint prosthesis system produced by Beijing Anshou Technology Co., Ltd. in total hip arthroplasty. This clinical study selected seven clinical centers and recruited 290 subjects. Each center competed for enrollment, with the requirement that each center should undertake no less than 8 cases and no more than half of the total cases. The enrollment stopped when the total number of cases met the design requirements. After the patients signed the informed consent form, they entered the screening process. After the screening was successful, the hip joint prosthesis system produced by Beijing Anshou Technology Co., Ltd. was implanted, and follow-up was conducted for the patients at \"before surgery, on the day of surgery, immediately after surgery until discharge, 2 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months after surgery, and 12 months after surgery.\" The demographic information and various evaluation indicators of the subjects were collected.",[59,27],"THA",[61,62,63,64],"total hip arthroplasty","Zirconia ceramic prosthesis","efficacy","safety","NOT_YET_RECRUITING","2026-01-25",{"date":68,"type":36},"2026-02-02",{"date":70,"type":21},"2026-01-01",{"date":72,"type":21},"2027-12-31",{"name":74,"class":43},"Peking University Third Hospital",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":82,"targetDuration":84,"studyType":56,"phases":4,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":44},"100619664","a-comparison-of-myoelectric-and-bionic-hands-100619664","NCT07347561","A Comparison of Myoelectric and Bionic Hands","Myoelectric and Bionic Hands in Upper Limb Amputations: A Comparison of Body Image, Function and User Satisfaction","Inclusion Criteria:\n\n* Aged 18 to 65 years\n* Individuals with unilateral upper limb amputation\n* Regular use of a prosthetic device for at least 6 months\n* Use of a semi-electronic elbow joint prosthetic component\n* Ability to understand and complete study assessments\n\nExclusion Criteria:\n\n* Presence of bilateral or multiple limb amputations\n* Proximal upper limb amputation at the shoulder level or above\n* Coexisting neurological or orthopedic disorders that may affect upper limb function or study outcomes",{"count":83,"type":21},20,"1 Day","This observational study aims to compare myoelectric and bionic hands in terms of upper extremity function, body image and satisfaction.\n\nThe main questions it aims to answer are:\n\n\\- Does upper extremity function differ between bionic and myoelectric hands?\n\nThe main questions it aims to answer are:\n\nDoes upper extremity function differ between bionic and myoelectric hands?",[87,88,27],"Amputation","Upper Limb Amputation",[87,90,91,92,93,94],"bionic hand","myoelectric hand","prosthesis","trans-humeral","trnas-radial","2026-01-09",{"date":97,"type":36},"2026-01-16",{"date":99,"type":36},"2025-11-01",{"date":101,"type":21},"2026-03-15",{"name":103,"class":43},"Gulhane School of Medicine",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":118,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":132},"100565947","limber-unileg-rapid-on-demand-and-scaled-up-manufacturing-of-customized-transtibial-prosthetic-legs-for-amputees-100565947","NCT06648798","LIMBER UniLeg: Rapid, On-demand, and Scaled-up Manufacturing of Customized Transtibial Prosthetic Legs for Amputees","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. Persons, aged 18 to 75\n4. In good general health as determined by clinical site monitor\n5. Weight \\\u003C 125kg\n6. Are not diabetic (self reported)\n7. Be a unilateral transtibial amputee of more than 1 year since amputation\n8. Have an existing prosthetic device(s) that does not use sensors or motors (is passive)\n9. Live in the Southern California region (within 50 miles of UCSD)\n10. Has sufficient sensation in residual limb as tested by the clinical site monitor\n11. Agreement to adhere to Lifestyle Considerations throughout study duration 11a. Use the testing device (EPD or UniLeg) only during the testing periods. 11b. Walk at least 14,000 steps per week (average of 1 mile per day). 11c. Maintain a similar diet and activity level throughout study duration (no abrupt changes of weight, activity, etc.)\n\nExclusion Criteria:\n\n1. Not currently using a prosthetic device\n2. Prosthetic device with active motors, sensors, etc.\n3. Pregnancy (due to fall risk)\n4. Diabetic (due to poor limb sensation), self reported\n5. No under 18 (due to inability to consent)\n6. No over 75 (due to fall risk)\n7. Poor proprioception or sensation at the residual limb","75 Years",{"count":112,"type":21},30,[24],"The LIMBER UniLeg, a 3D printed single-piece transtibial prosthetic limb, is sufficiently equivalent to traditional passive prosthetic limbs (no motors or sensors), while reducing the cost and time of manufacturing and enabling global reach through the use of digital technologies to solve the worldwide prosthetic accessibility crisis. This is a single-site, Phase I, Clinical Research Study to test the effectiveness and safety of the LIMBER UniLeg. One study group of 30 participants involved for two months using a non-inferiority design in which the participant will be assessed using their normal device (1 month) and the study device (1 month).",[116,27,117],"Amputation of Lower Limb","Non-inferiority Trial of Prothesis",[27,119,120,121],"Trans-tibial amputation","Limber Unileg","3D Printed","2024-11-25",{"date":124,"type":36},"2024-11-26",{"date":126,"type":36},"2023-12-20",{"date":128,"type":21},"2026-10-31",{"name":130,"class":131},"LIMBER Prosthetics & Orthotics Inc","INDUSTRY",2]