[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lower-limb-amputation-knee\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lower-limb-amputation-knee":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,71,101,126],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"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":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100548355","prosthetic-performance-enhancement-trial-100548355",false,"NCT06419920","Prosthetic Performance Enhancement Trial","PROSPER","Inclusion Criteria:\n\n* lower limb amputation at ankle (Symes) level and above\n* age 18+ years\n* fitted with a walking prosthesis and use it regularly for home and\u002For community ambulation\n* good socket fit, assessed by a score of 8-10 on the socket fit comfort scale\n* able to walk for three minutes at a time with or without an assistive device\n\nExclusion Criteria:\n\n* leg\u002Ffoot ulcer or other conditions that cause pain during weight-bearing\n* poor skin integrity that could cause tissue breakdown by walking\n* cardiovascular, respiratory or other critical health conditions that preclude moderate physical activity\n* unilateral or bilateral upper limb absence or loss at the wrist and above that precludes use of handrails bilaterally, or would require asymmetrical adaptation to body posture for use.\n* pregnancy","ALL","18 Years",{"count":19,"type":20},35,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of this research is to determine the feasibility of an uneven terrain walking program for lower limb prosthesis users. The training is designed to induce step-to-step variability during walking within a safe environment, with the aim of improving walking skill and confidence.",[26,27,28,29,30,31],"Amputation","Lower Limb Amputation Below Knee (Injury)","Lower Limb Amputation Above Knee (Injury)","Lower Limb Amputation at Ankle (Injury)","Lower Limb Amputation Knee","Lower Limb Amputation at Hip (Injury)","RECRUITING","2026-06-18",{"date":35,"type":36},"2026-06-23","ACTUAL",{"date":38,"type":36},"2025-06-26",{"date":40,"type":20},"2027-07",{"name":42,"class":43},"University of Nevada, Las Vegas","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":44},"100572784","clinical-and-functional-assessment-of-patients-with-transfemoral-amputation-treated-with-osteointegrated-implant-100572784","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.","65 Years",{"count":54,"type":20},15,[23],"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.",[58,30,59],"Prosthesis","Amputation; Traumatic, Leg, Lower",[61],"Osseointegration","2026-02-16",{"date":64,"type":36},"2026-02-17",{"date":66,"type":36},"2025-01-31",{"date":68,"type":20},"2027-01",{"name":70,"class":43},"Istituto Ortopedico Rizzoli",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":44},"100617860","clinical-application-observation-on-the-evaluation-of-phantom-limb-pain-with-the-suralis-system-100617860","NCT07324109","Clinical Application Observation on the Evaluation of Phantom Limb Pain With the Suralis System","Clinical Application Observation: Evaluation of Phantom Limb Pain After 3 Weeks of Use of a Feedback System Using Vibration (Suralis, Manufacturer: Saphenus)","Inclusion Criteria:\n\n* Unilateral major lower-limb amputation (transtibial or transfemoral)\n* Presence of persistent phantom limb pain, defined as daily pain intensity ≥ 3\u002F10 on the Visual Analog Scale (VAS) during the baseline period\n* Regular daily use of a prosthetic limb (minimum 4 hours\u002Fday)\n* Adequate German language proficiency to understand and complete study questionnaires and follow study procedures\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Unstable wound or skin condition at the residual limb\n* Inconsistent prosthetic use (less than daily or \\\u003C 4 hours\u002Fday)\n* Poorly fitting or non-functional prosthesis (as determined by study team)\n* Incapacity to provide informed consent (e.g., due to cognitive impairment or severe psychiatric illness)\n* Insufficient German language skills to comprehend study materials or complete assessments reliably",{"count":79,"type":20},20,[23],"This study tests whether a vibration-based feedback device (Suralis) can reduce phantom limb pain in people with lower-leg amputations over 3 weeks. Participants wear the device daily and report pain levels, walking ability, and quality of life - with no known risks, as it's a CE-certified medical device. If pain improves, the study team will help participants apply for insurance coverage to keep using the system long-term. The goal is to offer a simple, non-drug option that may help ease chronic pain and improve daily function for amputees. Participation is voluntary and can be stopped anytime without affecting medical care.",[83,84,85,30],"Phantom Limb Pain After Amputation","Lower Limb Amputation Above Knee","Lower Limb Amputation Below Knee",[87,88,89,90,91],"Phantom limb pain","Vibrotactile feedback","Lower limb amputation","Suralis system","Pain management","2025-12-23",{"date":94,"type":36},"2026-01-07",{"date":96,"type":36},"2025-04-01",{"date":98,"type":20},"2026-07-31",{"name":100,"class":43},"Median",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":21,"phases":110,"briefSummary":111,"conditions":112,"keywords":113,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":44},"100567403","promoting-physical-activity-following-dysvascular-amputation-100567403","NCT06667739","Promoting Physical Activity Following Dysvascular Amputation","A Behaviour Change Intervention Promoting Physical Activity Following Dysvascular Amputation: a Pilot Study","Inclusion Criteria:\n\n* Dysvascular LLA (LLA due to diabetes or vascular disease)\n* major LLA (at the ankle or above)\n* living in the community\n* adult at least 18 years of age\n* comfortable communicating in English and able to understand basic English\n* receptive to using a phone or tablet (e.g., to enable peer coaching, access to modules.\n\nExclusion Criteria:\n\n* actively receiving rehabilitation services related to physical activity\u002Fmobility\n* recommended medical supervision for physical activity by health care provider, or skin problems preventing usual activity\n* not able to provide informed consent.",{"count":109,"type":20},40,[23],"Loss of a lower limb due to diabetes can have a devastating impact on physical and mental health and quality of life. Individuals are at risk of other diseases such as cardiovascular disease, loss of the other limb and death. Physical activity can reduce risk of chronic disease and improve health outcomes; however, physical activity levels in people with limb loss are low, often due to reduced balance and walking ability. Rehabilitation services are not readily available and the cost of delivering such programs remains high. Working with individuals with lower limb amputation, we created a virtual, peer-led physical activity behaviour change intervention called IMproving Physical Activity through Coaching and Technology following Lower Limb Loss (IMPACT-L3). We will conduct a pilot study to assess feasibility and optimize design of a future trial of effectiveness.",[26,30],[114,115,116],"Physical activity","Behaviour change","Peer coaching","2025-02-20",{"date":119,"type":36},"2025-02-24",{"date":121,"type":36},"2025-01-23",{"date":123,"type":20},"2026-03",{"name":125,"class":43},"West Park Healthcare Centre",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":134,"sex":16,"minAge":135,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":21,"phases":138,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":44},"100435679","self-management-for-amputee-rehabilitation-using-technology-100435679","NCT04953364","Self-Management for Amputee Rehabilitation Using Technology.","Self-management for Amputee Rehabilitation Using Technology (SMART) Program: a Peer Supported mHealth Approach for Rehabilitation After Lower Limb Amputation","SMART","Inclusion Criteria:\n\n* Has a unilateral LLA (transtibial or transfemoral) due to diabetes or vascular disease\n* Received initial casting of their prosthesis within the past 2 years\n* Be aged ≥ 50 years (85% of adults with LLA)\n* Self-identifies as being able to speak and read English.\n* Has access to computer or tablet and internet.\n* Individuals living in British Columbia or Ontario, Canada.\n\nExclusion Criteria:\n\n* Substantial health conditions (e.g., congestive heart failure, diagnosed dementia)\n* Those anticipating further surgery (e.g. LLA revision) as identified by our study sites' physiatrists\n* an inability to use a tablet (e.g. using hands for typing).",true,"50 Years",{"count":137,"type":20},82,[23],"Lower Limb Amputations (LLAs) are a substantial burden on the Canadian health services with nearly 50,000 cases reported between 2006 and 2011. To address the challenging nature of a LLA (e.g., decreased mobility, pain, depression), patients need to go through extensive rehabilitation programs. Effective self-management programs can help those with LLA to monitor their own condition and improve their quality of life. However, a lack of self-management programs, a limited healthcare budget, and a decrease in quality of services (e.g. shorter lengths of stay for inpatients and rapid movement to outpatient services) pose further challenges for patients with LLA. Self-management programs can be provided to clients through online mobile technologies (e.g., tablet) and offer accessible, low-cost, and potentially augmentative rehabilitation after discharge, in both urban and rural areas. To address these needs, an online educational and training platform for individuals with LLA called, Self-Management for Amputee Rehabilitation using Technology (SMART) was designed and developed. SMART focuses on LLA education, prosthetic limb management, and weekly support of peers. It is monitored by a trainer through a website. SMART will be evaluated in men and women with LLA aged 50 years and over, admitted to prosthetic rehabilitation throughout BC and ON. SMART has the potential to influence a client's post-LLA needs with direct (e.g., individual's health) and indirect (e.g., healthcare utilization) benefits. The purpose of this randomized controlled trial is to evaluate the effect of SMART in community dwelling older adults with unilateral, above or below, knee amputation.",[141,26,28,27,30],"Behavior","2024-07-19",{"date":144,"type":36},"2024-07-23",{"date":146,"type":36},"2022-10-14",{"date":148,"type":20},"2026-02-01",{"name":150,"class":43},"University of British Columbia"]