Effect of Prophylactic TMR and RPNI on Neuroma and Phantom Limb Pain (NCT05344261) | Clinical Trial Compass
WithdrawnNot Applicable
Effect of Prophylactic TMR and RPNI on Neuroma and Phantom Limb Pain
Stopped: study never initiated and no participants enrolled
0Started 2023-03-01
Plain-language summary
The purpose of this study is to analyze the efficacy of novel interventions in post-amputation surgical care (specifically Targeted Muscle Reinnervation and Regenerative Peripheral Nerve Interface) on post-amputation pain and functional outcomes at the time of amputation. These novel interventions have been shown to be successful in treating the downstream effects of amputations (pain, phantom limb pain, neuroma pain, etc.), but has not been studied in a randomized manner at the time of amputation.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients ≥18 years old
* Patients scheduled for amputation of upper or lower extremity (including digit, ray, and hand) as a primary or secondary sequela of trauma.
* Patients scheduled for amputation of upper or lower extremity (including digit, ray, and hand) for primary or secondary sequelae of malignancy.
* Secondary sequalae include but is not limited to metastatic disease and osteolytic disease.
* Patients scheduled for amputation of upper or lower extremity (including digit, ray, and hand) for vasculitic diseases.
Exclusion Criteria:
* Patients less than 18 years old
* Patients with cognitive impairment
* Patients who are imprisoned at the time of randomization
* Patients currently enrolled in other studies relating to neuropathic pain
* Patients actively undergoing radiation therapy
* Patients with existing neuroma or underwent prior neuroma surgery
* Patients with amputations scheduled congenital reasons
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Phantom Limb Pain
Timeframe: Specifically at the time point 1 year after their primary incisions have healed.
Trial details
NCT IDNCT05344261
SponsorUniversity of Texas Southwestern Medical Center