[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"transtibial-amputee\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:transtibial-amputee":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100607969","early-phase-1-feasibility-study-evaluating-the-safety-and-effectiveness-of-magnetic-bead-tracking-system-when-used-with-a-bionic-external-prosthesis-100607969",false,"NCT07195461","Feasibility Study Evaluating the Safety and Effectiveness of Magnetic Bead Tracking System When Used With a Bionic External Prosthesis","A Feasibility Study Evaluating the Magnetic Bead Tracking System and Its Safety and Effectiveness When Used With a Bionic External Prosthesis to Improve Prosthetic Controllability for Persons With Transtibial Amputation","Inclusion Criteria:\n\n* Male or Female age 22-65 at the time of surgery.\n* The patient must already have an existing unilateral or bilateral transtibial amputation requiring revision or a medical condition requiring performance of a unilateral or bilateral transtibial amputation.\n* If the patient does not already have an amputation, the patient must have undergone independent consultation with a lower extremity surgical specialist to ensure they have exhausted all limb salvage options prior to undergoing amputation, as well as a psychiatric evaluation to ensure appropriate capacity and volition, and a pain medicine evaluation to ensure that all pain control options outside of amputation have been addressed.\n* The patient must have the ability to ambulate at variable cadence (an expected lower extremity prosthesis functional level of K3 or above, as determined by a trained and certified prosthetist and confirmed by study investigators, through use of a patient history and physical examination).\n* The patient must have adequate soft tissue bulk and muscle mass present in the operative limb to support appropriate wound healing.\n* The patient must demonstrate volitional activation of the muscles into which magnet placement is intended.\n* In the opinion of the investigator, the patient must likely be able to tolerate the pressure of a prosthetic socket during ambulation post-operatively.\n* In the opinion of the investigator, the patient must have absence of any physical limitations, addictive diseases or underlying medical conditions that may preclude the patient from being a good study candidate.\n* The patient must have willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study.\n* The patient must have willingness and ability to provide informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Patients with any active skin disease in the subject limb.\n* Patients with severe comorbidity, atypical skeletal anatomy, or poor general physical\u002Fmental health that, in the opinion of the Investigator, will not allow the patients to be a good study candidate (i.e., other disease processes, mental capacity, substance abuse, shortened life. expectancy, vulnerable patient population, etc.).\n* Patients with the following concurrent diseases: active infection or dormant bacteria, metabolic bone disease and\u002For metastatic lesions in the residual tibia.\n* Patients weighing over 285 lbs. with the prosthesis, at time of screening.\n* Patients for whom skeletal growth is not complete. Completed skeletal growth is defined through the finding of generally closed epiphyseal zones on X-ray.\n* Patients with advanced atrophic muscle and\u002For compromised soft tissue coverage in the operative limb.\n* Patients with evidence of or a documented history of severe peripheral vascular disease, diabetes mellitus (type I or type II), skin diseases, neuropathy or neuropathic disease and severe phantom pain, or osteoporosis, such that, in the opinion of the investigator, will not allow the patient to be a good study candidate.\n* Patient with a history of systemically administered corticosteroids, immune-suppressive therapy or chemotherapy drugs within six (6) months of implant surgery.\n* Patients with a known need of future MRIs.\n* Patients currently involved in another clinical study where that participation may conflict or interfere with the treatment, follow-up or results of this clinical study.\n* Active smokers will be excluded from candidacy; those patients willing to undergo tobacco cessation will need to be completely abstinent from tobacco use for at least 6 weeks preoperatively.\n* Women who are pregnant, lactating or planning a pregnancy during the first twelve (12) months of the post-surgical follow-up.\n* Patient having an allergy to any component of the device.\n* Patients with concurrent illness, disability or geographical residence that would hamper attendance at required study visits.","ALL","22 Years","65 Years",{"count":20,"type":21},3,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","The investigation is an early feasibility study in up to 5 subjects, in which the primary objective is to capture preliminary safety and effectiveness information on the Magnetic Bead Tracking system.",[27,28],"Transtibial Amputee","Transtibial Amputation",[30,31,32,33,34],"transtibial","amputation","amputee","magnet","prosthesis","RECRUITING","2025-09-19",{"date":38,"type":39},"2025-09-26","ACTUAL",{"date":41,"type":39},"2025-09-11",{"date":43,"type":21},"2026-04",{"name":45,"class":46},"MuscleMetrix, LLC","INDUSTRY"]