Regenerative Peripheral Nerve Interfaces to Treat Painful Digit and Hand Neuromas After Amputation

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Regenerative Peripheral Nerve Interfaces to Treat Painful Digit and Hand Neuromas After Amputation: A Prospective Observational Trial

Conditions
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Neuroma

Intervention / Treatment
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* Procedure: Regenerative Peripheral Nerve Interface (RPNI) surgery
* Procedure: Traction Neurectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Must be seen by a hand therapist for at least 6-week trial of desensitization therapy Exclusion Criteria: 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 adults who are unable to consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Regenerative Peripheral Nerve Interface<br>symptomatic neuroma is excised, and the end of the peripheral nerve is implanted into a small denervated free muscle graft harvested from the patient | Procedure: Regenerative Peripheral Nerve Interface (RPNI) surgery<br>* Surgeons will perform neuroma resection and RPNI creation using a free muscle graft from the brachioradialis muscle harvested through a small separate incision<br>|
| Traction Neurectomy<br>simple excision and traction neurectomy | Procedure: Traction Neurectomy<br>* Surgeons will perform neuroma resection and traction neurectomy,<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 . | 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. | 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. | 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. | 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. | Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 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. | 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 | 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. | 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 | 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 | 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 | 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 | 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. | 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 | 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 | Assessing change from Baseline to 1 month, 3 months and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuroma, Neuroma Pain, Finger Amputation, Hand Amputation