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
This will be a prospective observational study that seeks to provide a comprehensive assessment of the outcomes after RPNI surgery compared to standard of care by utilizing multiple established and validated patient-reported outcomes measures, carefully tracking pre- and post-operative pain regimens, and performing functional and physiologic tests.
Study Type
OBSERVATIONAL
Enrollment
80
Surgeons will perform neuroma resection and RPNI creation using a free muscle graft from the brachioradialis muscle harvested through a small separate incision
Surgeons will perform neuroma resection and traction neurectomy,
The Curtis National Hand Center at Medstar Union Memorial Hospital
Baltimore, Maryland, United States
RECRUITINGUniversity of Michigan Plastic Surgery
Ann Arbor, Michigan, United States
NOT_YET_RECRUITINGPatient-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.
Time frame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months
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 .
Time frame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months
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.
Time frame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months
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.
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Time frame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months
Generalized Anxiety Disorder measure (GAD-7),
Generalized Anxiety Disorder measure (GAD-7) is a screening tool and severity measure for generalised anxiety disorder (GAD) over the past 2 weeks consisting of 7 questions answered on a scale of 0-3 with 0 being the best and 3 being the worst.
Time frame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months
PC-PTSD-5
The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) is a 5-item screening tool with 'Yes/No" answers designed to identify individuals with probable PTSD. Yes" answers represent the worst and "no" represents the best.
Time frame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months
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.
Time frame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months
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.
Time frame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months
Grip Strength
A standard dynamometer will be used to evaluate grip strength
Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months
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.
Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months
Range of Motion
Evaluate active and passive range of motion of all joints in the affected extremity proximal to the amputation stump, total active and passive range of motion of all unaffected digits on the ipsilateral hand, and total active motion of fall digits and wrist on the contralateral hand as an internal control
Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months
Fine Motor Function - 9-Hole Peg Test (9HPT)
Evaluate timed exercise during which nine relatively small pegs are picked up, one at a time, and put into nine corresponding holes. The pegs are then removed from the holes (one at a time) and placed back in the starting bin.
Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months
FunctionalTask Testing - Lifting boxes
Evaluate whether the participant is able to perform the task, grip that was used, maximum weight used, and any compensatory findings. Subjects will be asked their pain level during each lift using a 10-point numerical scale
Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months
Functional Task Testing - Carrying Boxes
Evaluate whether the participant is able to perform the task, grip that was used, maximum weight used, and any compensatory findings. Subjects will be asked their pain level during each lift using a 10-point numerical scale
Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months
Functional Task Testing - Push/Pull sled
Evaluate whether the participant is able to perform the task, grip that was used, maximum weight used, and any compensatory findings. Subjects will be asked their pain level during each lift using a 10-point numerical scale
Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months
Functional Task Testing - Hammer
Evaluate tolerance for vibration and grip to perform a hammer task using
Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months
Functional Task Testing - Vice Grip
Evaluate vice grip Strength with all available digits using the Baltimore Therapeutic Equipment (BTE) PrimusRS work simulator.
Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months
Functional Task Testing - Gear Shifting
Evaluate ability to grip, push and pull gear shift with all available digits using the Baltimore Therapeutic Equipment (BTE) PrimusRS work simulator
Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months
Functional Task Testing - Weapon Recoil
Evaluate the ability to preform this simulated task using the Baltimore Therapeutic Equipment (BTE) PrimusRS work simulator
Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months