View clinical trials related to Transhumeral Amputation.
Filter by:An FDA Early Feasibility Study (EFS) allows for early clinical evaluation of devices to provide proof of principle and initial clinical safety data. The Primary Aim of this proposal is to perform an FDA guided EFS of a percutaneous osseointegrated (OI) docking system for patients with transhumeral (above elbow) amputations, establishing its initial safety. Success of the Primary Aim (Safety) will be determined over a one year follow-up period by observing the rate of patients successfully using their device without removal. The Secondary Aim of this proposal is to quantify the functional effectiveness of the OI device, giving specific attention to protocol differences required for male and female patients. Success for the Secondary Aim (Functional Effectiveness) will be to determine functional improvement with the device compared to the pre-operative performance. This will be the first longitudinal analyses to evaluate the percutaneous OI devices on objective functionality measures of transhumeral amputation individuals.
This study will quantify motion occurring at the socket interface of transhumeral prosthesis users during common tasks. Participants in the study will use a body powered prosthesis with a hosmer hook terminal device. A motion analysis system and a novel optical sensor embedded into the socket wall will record the amount of movement between the residual limb and socket of the prosthesis. Participants will complete range of motion and functional tasks. The range of motion tasks include shoulder flexion, abduction and rotation as well as elbow flexion. The functional tasks include bilateral lift of weighted basket, unilateral lift of weighted handle, box and blocks test, walk and carry a gallon of milk, and folding a towel. It is expected that the more weight at the terminal device the more rotation at the interface, as well as more slip between residual limb and device. It is also expected that the soft tissues of the residual limb can be modeled as a nonlinear spring and the amount of movement at the interface can be predicted based off the force in the system.