Status:
WITHDRAWN
Effect of Prophylactic TMR and RPNI on Neuroma and Phantom Limb Pain
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Amputation
Neuroma Amputation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
The investigators plan a randomized control trial of all eligible patients undergoing major limb amputation at Parkland Memorial Hospital. Eligible patients undergoing an amputation will be consented ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05344261
Start Date
March 1 2023
End Date
December 30 2024
Last Update
December 5 2023
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