About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Questionnaire Administration
Other interventionAncillary studies
Regenerative Peripheral Nerve Interface Surgery
Procedure/SurgeryUndergo regenerative peripheral nerve interface surgery
Targeted Muscle Reinnervation
Procedure/SurgeryUndergo targeted muscle reinnervation
Treatment groups
Trial outcomes
Primary outcomes
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Sponsors and contacts
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