e-OPRA Implant System for Lower Limb Amputees

Inclusion Criteria: A potential subject will be included in the study if she/he meets all of the following inclusion criteria: * Male or Female age 22-65 at the time of surgery. * The patient must have a medical condition requiring performance of a unilateral transfemoral amputation with a minimum of 13 cm of residual femur after amputation, and: A: At a minimum level of amputation of 20 cm or greater above the knee joint line if physical therapy and prosthetist evaluation is commensurate with a standard K3 ambulatory status; or, B: At a minimum level of amputation of 16 cm above the knee joint line as part of a single-stage procedure if physical therapy and prosthetist evaluation is commensurate with a more active K3 or less active K4 postoperative ambulatory status. * The subject must have undergone independent consultation with at least two lower extremity surgical specialists 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. * The patient must have the ability to ambulate at variable cadence (an expected lower extremity prosthesis functional level of K3 or above). * The patient must have adequate bone stock to support the implanted device. * In the opinion of the investigators, normal cognitive function and absence of any physical limitations, addictive diseases or underlying medical conditions that may preclude patient from being a good surgical and/o…