This study is being done to demonstrate the effectiveness of Regenerative Peripheral Nerve Interfaces (RPNI) surgery in treating symptomatic neuromas of the hand and digits following amputation compared to standard of care using a Prospective, Observational Trial
18 years or older
History of unilateral digit, multiple digit, or partial hand amputation
Discrete neuroma pain on clinical exam
Following standard of care (SOC), confirmation through a local block and/or ultrasound imaging will be performed if indicated
Patients with previous surgical treatment for symptomatic neuromas of the digits or hand
Patients with other major injuries more proximal in the ipsilateral extremity that cause chronic pain or functional loss
women pregnant at time of enrollment
prisoners
Patients 18 years or older with a history of digit, multi-digit or partial hand amputation. Patients must have discrete neuroma pain on clinical exam.
Case-only
Prospective
Regenerative Peripheral Nerve Interface (RPNI) surgery
Procedure/SurgerySurgeons will perform neuroma resection and RPNI creation using a free muscle graft from the brachioradialis muscle harvested through a small separate incision
Traction Neurectomy
Procedure/SurgerySurgeons will perform neuroma resection and traction neurectomy,
Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI)
PROMIS Pain Interference (PROMIS-PI) scale measures the extent to which pain hinders an individual's engagement with physical, mental, cognitive, emotional, recreational, and social activities over the past 7 days answering each questions with a response of not at all, a little bit, somewhat, quite a bit, and very much with not at all being the best and very much the worst.
Short-form McGill Pain Questionnaire (SF-MPQ-2)
theShort-form McGill Pain Questionnaire (SF-MPQ-2) measures 24 different qualities of pain and related symptoms using the intensity of pain and related symptoms felt during the past week on 0 to 10 scale, with 0 being no pain and 10 being the worst pain .
PROMIS Global Health (GH) v1.2
The Global Health Questionnaire contains 10 questions (7 general and 3 about the last 7 days). First 7 questions use a scale of excellent, very good, good, fair, and poor, poor being the worst with excellent being the best. The other three questions use different scales such as; never rarely, sometimes, often or always with never being the best and always being the worst; as well as none, mild, moderate, severe, very severe with none being the best and very severe being the worst; finally pain rating numbered 0-10 with 0 being no pain and 10 being the worst pain imaginable.
Patient Health Questionnaire (PHQ-9),
The PHQ-9 form is a brief, self-administered questionnaire that assesses depression symptoms over the last 2 weeks consisting of 10 questions. 9 will be answered on a scale of 0-3 with 0 being the best and 3 bing the worst. The last question will use a response of not difficult at all, somewhat difficult, very difficult, and extremely difficult with not difficult at all being the best and extremely difficult being the worst.
PROMIS UpperExtremity (UE)
PROMIS UpperExtremity (UE) is designed to evaluate upper extremity function using a scale of 1-5 with 5 being the best possible answer and 1 being the worst.
Brief Michigan Hand Outcomes Questionnaire (bMHQ)
The Brief Michigan Hand Outcomes Questionnaire (bMHQ) evaluates six upper extremity domains of function, activities of daily living(ADLs), aesthetics, performance,pain,and satisfaction using a scale of 1-5 with 5 being the best possible answer and 1 being the worst.
Grip Strength
A standard dynamometer will be used to evaluate grip strength
Pinch Strength -Key and Three-point
Evaluate key pinch (thumb to radial border of index) and three-point pinch (index, middle, and thumb tips) strength.
Click on the lead sponsor to view all of their trials.
Medstar Health Research Institute
Lead sponsor
United States Department of Defense
Collaborator
University of Michigan
Collaborator
