Cette étude vise à explorer la sécurité et l'efficacité d'une nouvelle technologie appelée Système de Suivi par Billes Magnétiques, conçu pour aider les personnes amputées de la jambe inférieure à contrôler un dispositif prothétique de cheville-pied. L'étude se concentre sur les personnes ayant des amputations trans-tibiales, ou sous le genou. Cette technologie pourrait potentiellement améliorer la façon dont les personnes portant des membres prothétiques se déplacent en offrant un contrôle plus naturel et intuitif. L'objectif est de déterminer si ce système peut offrir un meilleur contrôle par rapport aux contrôleurs prothétiques existants, ce qui pourrait grandement améliorer la qualité de vie des personnes utilisant des prothèses. Les participants à l'étude auront un petit nombre de billes magnétiques implantées dans les muscles de leur membre résiduel. Ces billes, ainsi que des capteurs externes, suivront les mouvements musculaires pour aider à contrôler le membre prothétique. L'étude mesurera la capacité des participants à marcher et à naviguer dans des obstacles en utilisant ce système par rapport à un système de contrôle prothétique traditionnel. La sécurité est une préoccupation majeure, avec un suivi étroit de tout effet secondaire potentiel tout au long de l'étude. Les participants seront invités à rapporter leurs sensations et subiront des contrôles réguliers pour garantir que le système est sûr et efficace. L'étude recueillera des données qualitatives et quantitatives pour évaluer les améliorations de la vitesse de marche et de la manœuvrabilité.
Inclusion Criteria: * Male or Female age 22-65 at the time of surgery. * 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. * 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. * 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). * The patient must have adequate soft tissue bulk and muscle mass present in the operative limb to support appropriate wound healing. * The patient must demonstrate volitional activation of the muscles into which magnet placement is intended. * In the opinion of the investigator, the patient must likely be able to tolerate the pressure of a prosthetic socket during ambulation post-operatively. * 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. * The patient must have willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study. * The patient must have willingness and ability to provide informed consent to participate in the study. Exclusion Criteria: * Patients with any active skin disease in the subject limb. * Patients with severe comorbidity, atypical skeletal anatomy, or poor general physical/mental 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.). * Patients with the following concurrent diseases: active infection or dormant bacteria, metabolic bone disease and/or metastatic lesions in the residual tibia. * Patients weighing over 285 lbs. with the prosthesis, at time of screening. * Patients for whom skeletal growth is not complete. Completed skeletal growth is defined through the finding of generally closed epiphyseal zones on X-ray. * Patients with advanced atrophic muscle and/or compromised soft tissue coverage in the operative limb. * 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. * Patient with a history of systemically administered corticosteroids, immune-suppressive therapy or chemotherapy drugs within six (6) months of implant surgery. * Patients with a known need of future MRIs. * 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. * 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. * Women who are pregnant, lactating or planning a pregnancy during the first twelve (12) months of the post-surgical follow-up. * Patient having an allergy to any component of the device. * Patients with concurrent illness, disability or geographical residence that would hamper attendance at required study visits.
est désigné dans cette étude