Short-term Implanted Electrodes Following Regenerative Peripheral Nerve Surgery for Improv
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.
| Condition(s) | Amputation Neuroma, Amputation |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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. * |
| Ages | 22 Years to 75 Years |
| Sex | All |
| Lead sponsor | University of Michigan |
| Locations | Ann Arbor, Michigan, United States |
| Start date | 2017-12-11 |
| NCT ID | NCT03260400 |
| Official listing | https://clinicaltrials.gov/study/NCT03260400 |