Short-term Implanted Electrodes Following Regenerative Peripheral Nerve Surgery for Improving Prosthetic Limb Control Signals
Trial Parameters
Brief Summary
The device, a bipolar percutaneous intramuscular electromyography electrode, is intended for use in upper-limb amputation patients who have received the regenerative peripheral nerve interface surgical procedure, in order to enable the use of advanced prosthetic arms and hands.
Eligibility Criteria
Inclusion Criteria: * Participants must be 22 years of age or older. * Participants must have previously undergone an upper limb amputation proximal to the wrist. * For participants without existing RPNI grafts (at the time of enrollment), the residual limb must have sufficient soft tissue quality to support performance of the RPNI operative procedure. Participants sustaining severe crushing or avulsion injuries with substantial superficial and deep scarring may not be appropriate candidates for inclusion in the study. * Participants must be in good health and American Society of Anesthesiologists (ASA) Class I or II (low surgical risk). * Participants must have reliable transportation. * Participants must be able to attend at minimum 2 visits per month while electrodes remain implanted. * Participants must be at least 6 months post-amputation. Exclusion Criteria: * Participants may not be suffering from any severe pain syndrome including complex regional pain syndrome or severe phanto