Target Muscle Re-innervation and Regenerative Peripheral Nerve Interfaces Alone and in Com
This clinical trial evaluates two surgical techniques (targeted muscle re-innervation \[TMR\] and regenerative peripheral nerve interfaces \[RPNI\]) alone and in combination for the alleviation of chronic residual limb and phantom limb pain in cancer patients who have had an amputation. Chronic residual limb pain and p
| Condition(s) | Amputation |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This clinical trial evaluates two surgical techniques (targeted muscle re-innervation \[TMR\] and regenerative peripheral nerve interfaces \[RPNI\]) alone and in combination for the alleviation of chronic residual limb and phantom limb pain in cancer patients who have had an amputation. Chronic residual limb pain and phantom limb pain are debilitating outcomes of traumatic and oncologic amputation. Emerging microsurgical treatments for post-amputation pain are very promising. TMR and RPNI are both approved surgical techniques that involve connecting cut nerves to parts of the muscle as a way to heal and protect the nerves. This trial evaluates these techniques alone and in combination for the treatment of residual and phantom limb pain in cancer patients who have received an amputation. |
| Who can participate | Inclusion Criteria: * Patients greater than or equal to 18 years of age who are receiving an amputation for oncologic reasons * Patients with available mixed major nerves and donor motor nerves in the amputation stump or reconstructive tissue * Patients able to complete informed consent Exclusion Criteria: * Patients under 18 years of age * Patients unable to give consent * Patients receiving an amputation for non-oncologic purposes * Patients with amputations performed for immediate palliation (life expectancy less than 3 months), as this technique takes a minimum of 3-6 months for effect * Patients with multiple limb amputations * Patients receiving nerve management in a delayed fashion (patients who have previously received an amputation and present with neuroma) |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | M.D. Anderson Cancer Center |
| Locations | Houston, Texas, United States |
| Start date | 2020-08-10 |
| NCT ID | NCT06840262 |
| Official listing | https://clinicaltrials.gov/study/NCT06840262 |