The study of osseointegrated transtibial prosthesis with neural interface (TTeOPRA)
Massachusetts Institute of Technology is recruiting patients for the clinical trial of Osseointegrated Transtibial Prosthesis With Neural Interface (TTeOPRA).
The e-OPRA Implant System, is a further development of the OPRA (Osseointegrated Prostheses for the Rehabilitation of Amputees) Implant System. The e-OPRA Implant system is an implant system for direct skeletal anchorage of amputation prostheses. The added feature in the e-OPRA Implant system, is a bidirectional interface into the human body that allows permanent and reliable communication using implanted electrodes. These electrodes will provide long-term stable bioelectric signals for an improved control of the prosthetic limb. The purpose of the study is to evaluate the feasibility of a transtibial amputee with the e-OPRA Implant System exhibiting full neural control over a neuro-mechanical prosthetic system. A maximum of two subjects will be enrolled. Each subject will undergo a surgery where the e-OPRA Implant System will be implanted. The subjects will participate in follow-up sessions of which the last one occurs approximately 24 months after the surgery. This is a prospective, non-randomized, uncontrolled study.
Normalization of function for individuals with limb amputation is within reach, and will be achieved by smart implants capable of bi-directional communication between brain and machine via bone-anchored, interactive, powered prosthetic components. Rehabilitation of patients with expected high physical activity level, such as after amputation due to trauma or cancer, is currently limited by dependence on an external socket for the mechanical attachment of the prosthesis to the residuum. Despite the use of advanced materials and fabrication methods, socket interfaces routinely cause sores, chafing, pain, increased energy expenditure, and a decreased quality of life.
The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT05249049.
