[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"amputation-traumatic-leg-thigh-between-hip-and-knee\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:amputation-traumatic-leg-thigh-between-hip-and-knee":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,59],{"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":32,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100588119","effects-of-microprocessor-controlled-prosthetic-knees-on-fall-related-health-outcomes-in-limited-community-ambulators-100588119",false,"NCT06937242","Effects of Microprocessor-controlled Prosthetic Knees on Fall-related Health Outcomes in Limited Community Ambulators","Fall-related Health Outcome in Lower Limb Prosthesis Users: A Pragmatic Clinical Trial to Assess Effectiveness of Microprocessor-controlled Prosthetic Knees","Inclusion Criteria:\n\n* Unilateral transfemoral or knee disarticulation limb loss.\n* 6 months or longer since time of limb loss.\n* Current user of a prosthesis with a non-microprocessor-controlled prosthetic knee.\n* Received a replacement prosthesis with a non-microprocessor knee in the past 4-24 months.\n* Clinician has deemed patient limited community ambulator (Medicare functional classification level K2).\n* In addition, Medicare functional classification level K2 as determined by at least one of the following criteria:\n\n  1. Houghton Score: 5-10\n  2. Prosthetic Limb Users Survey of Mobility (PLUS-M) T-Score: if amputation etiology is vascular disease\u002Fdiabetes \\\u003C49.45, otherwise, \\\u003C36.75.\n  3. Amputee Mobility Predictor (AMPPRO) score: 27-42 collected within the last 24 months\n* Ability to read, write, and understand English.\n\nExclusion Criteria:\n\n* Any health condition that would prevent safely completing trial activities.\n* Any individuals that weigh 275 lbs or more.\n* Any individuals who wear their prosthesis less than 3 days a week or less than a total of 24 hours a week\n* Individuals with a history of acute or chronic residual limb breakdown\n* Individuals with declining health status such that he\u002Fshe subsequently reports reduced activity over the past 6 months","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this study is to find out if using microprocessor-controlled prosthetic knees (MPKs), prosthetic knees with a built-in computer, improves health outcomes related to falls in adults who use above-knee prostheses. The main questions are:\n\n* Do individuals with MPKs have fewer fall-related health issues compared to those with non-microprocessor-controlled prosthetic knees (nMPKs)?\n* Do individuals with MPKs have increased mobility, faster walking speed, and improved quality of life compared to those with nMPKs?\n\nParticipants who have recently received an nMPK as part of their regular care can join the study. Those randomized to the control group will keep using their nMPK, while those randomized to the intervention group will receive a stance-and-swing MPK or a stance-only MPK.",[26,27,28,29,30,31],"Amputation","Prosthesis User","Amputation; Traumatic, Leg: Thigh, Between Hip and Knee","Limb; Absence, Congenital, Lower","Lower Limb Amputation Above Knee (Injury)","Lower Limb Amputation Above Knee",[33,34,35,36,37,38,39,40,41,42,43,44,45],"amputation","lower limb amputation","lower limb prosthesis user","mechanical knee","microprocessor knee","transfemoral amputation","knee disarticulation","prosthetic knee","falls","falling","amputee","transfemoral amputee","MPK","RECRUITING","2026-02-03",{"date":49,"type":50},"2026-02-05","ACTUAL",{"date":52,"type":50},"2025-07-11",{"date":54,"type":20},"2027-02",{"name":56,"class":57},"Hanger Institute for Clinical Research and Education, LLC","INDUSTRY",1,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":21,"phases":68,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":58},"100531057","clinical-outcomes-with-non-powered-vs-powered-prosthetic-knees-by-k2-level-amputees-100531057","NCT06194838","Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees","Clinical Outcomes Associated With At Home Use of Non-Powered vs. Powered Prosthetic Knees by K2-level Individuals With Transfemoral Amputations","Inclusion Criteria:\n\n* Are at least 18 years old\n* Transfemoral prosthesis user (limb absence between the knee and hip)\n* Current user of a mechanical knee\n* Regularly wears prosthesis at least 5 days per week\n* Have adequate clearance between distal end and ground for necessary knee and foot components\n* Current Medicare Functional Classification Level (K-Level) of 2 as determined by the healthcare team\n* Socket-Comfort Score: 6 or above to ensure adequate socket fit\n* Six months or more experience on a prosthesis\n* Body weight between 50kg and 116kg (110lbs - 256lbs)\n* Height between 1.2m and 1.95m (47.2in and 76.8in)\n* Has a phone to answer periodic study calls\n\nExclusion Criteria:\n\n* Present injuries to residual limb or contralateral leg affecting functional ability\n* Contralateral amputation proximal to MTP (metatarsophalangeal) joint\n* Socket issues\u002Fchanges in the last 6 weeks\n* Users with bone-anchored implants\n* Health or medical condition, diagnosis, or other cause that would prevent participant from effectively following study protocol, performing required outcome measures, and\u002For completing the study\n\nSubjects can be excluded at the discretion of the investigator for other unforeseen disqualifying criteria (such as specific cognitive issues, etc.).\n\nIf subjects experience a health or medical condition that leaves them immobile for more than 2 weeks, they may be given the option to restart the study condition upon recovery, as long as eligibility criteria is still met, and comparable baseline functionality is demonstrated with outcomes measures.\n\nUsing a knee that the subject is unfamiliar with may increase the risk of falling. Therefore, pregnant women should not participate in the study and will be screened by self-disclosure.",{"count":67,"type":20},26,[23],"The goal of this proposed project is to gather community-based data from the K2-level Transfemoral Amputee (TFA) population to aid in evidence-based prescription of powered prosthetic knees (i.e., choosing the right device to maximize the benefit for each patient). The investigators intend to use this trial data along with a concurrent study being conducted within the K3-K4 level population to guide the implementation of effective prescriptions towards those that can benefit most from a given device and limit prescription to those who would not see benefit in order to ensure the most judicious use of Department of Defense (DoD) and Veteran's Affairs healthcare dollars. The findings will also be shared with the research community to help drive the design of future devices by identifying what features and functions are most beneficial to which patient populations when the devices are used outside of the laboratory. In summary, more community-based data on how powered prosthetic knees compare with the current standard in TFA populations is needed to allow for improved clinical decision making and clinical outcomes.",[26,71,29,27,30,28],"Amputation; Traumatic, Leg, Lower",[43,73,44,40,74,36,35],"lower limb amputee","power knee","2025-09-02",{"date":77,"type":50},"2025-09-03",{"date":79,"type":50},"2023-09-12",{"date":81,"type":20},"2026-08-31",{"name":83,"class":57},"Liberating Technologies, Inc."]