NeuromaNCT05008185
Regenerative Peripheral Nerve Interfaces to Treat Painful Digit and Hand Neuromas After Amputation
An observational study of Neuroma, run by Medstar Health Research Institute at 2 sites in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuroma
- What is being tested?
- Regenerative Peripheral Nerve Interface (RPNI) surgery and Traction Neurectomy
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Oct 2021to Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
University of Michigan Plastic Surgery
Ann Arbor, Michigan, 48109
Jenni Hammill, M.P.H, 570-559-7912, jenberry@med.umich.edu
Theodore A Kung, MD
- Recruiting
The Curtis National Hand Center at Medstar Union Memorial Hospital
Baltimore, Maryland, 21218
Ike Fleming, 410-554-2486, ike.c.fleming@medstar.net
Alessandra Butanis, 410-554-2123, alessandra.l.butanis@medstar.net
About this study
Official title: Regenerative Peripheral Nerve Interfaces to Treat Painful Digit and Hand Neuromas After Amputation: A Prospective Observational Trial"
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
Read the detailed description
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.
- Conditions
- Neuroma
- Being tested
- Regenerative Peripheral Nerve Interface (RPNI) surgery, Traction Neurectomy
- Keywords
- Neuroma, Neuroma Pain, Finger Amputation, Hand Amputation
- Medical subject headings
- Neuroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regenerative Peripheral Nerve Interface (RPNI) surgeryProcedure or surgery
Surgeons will perform neuroma resection and RPNI creation using a free muscle graft from the brachioradialis muscle harvested through a small separate incision
Traction NeurectomyProcedure or surgery
Surgeons will perform neuroma resection and traction neurectomy,
| Study group | Role | What they receive |
|---|---|---|
| Regenerative Peripheral Nerve Interface | symptomatic neuroma is excised, and the end of the peripheral nerve is implanted into a small denervated free muscle graft harvested from the patient Receives: Procedure: Regenerative Peripheral Nerve Interface (RPNI) surgery | |
| Traction Neurectomy | simple excision and traction neurectomy Receives: Procedure: Traction Neurectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 .
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: Assessing change from Baseline to 1 month, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start5 Oct 2021
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for NeuromaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, University of Michigan
- Responsible party
- Sponsor
- Investigators
- Aviram M Giladi, MS, MD, Principal investigator, Medstar Union Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008185
- Sponsor's protocol ID
- Pro00049513
- Status last verified
- Nov 2024
- First submitted
- 28 Jul 2021
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Woo SL, Kung TA, Brown DL, Leonard JA, Kelly BM, Cederna PS. Regenerative Peripheral Nerve Interfaces for the Treatment of Postamputation Neuroma Pain: A Pilot Study. Plast Reconstr Surg Glob Open. 2016 Dec 27;4(12):e1038. doi: 10.1097/GOX.0000000000001038. eCollection 2016 Dec.
PubMed 28293490Urbanchek MG, Kung TA, Frost CM, Martin DC, Larkin LM, Wollstein A, Cederna PS. Development of a Regenerative Peripheral Nerve Interface for Control of a Neuroprosthetic Limb. Biomed Res Int. 2016;2016:5726730. doi: 10.1155/2016/5726730. Epub 2016 May 17.
PubMed 27294122Santosa KB, Oliver JD, Cederna PS, Kung TA. Regenerative Peripheral Nerve Interfaces for Prevention and Management of Neuromas. Clin Plast Surg. 2020 Apr;47(2):311-321. doi: 10.1016/j.cps.2020.01.004. Epub 2020 Feb 1.
PubMed 32115057Kemp SW, Cederna PS, Midha R. Comparative outcome measures in peripheral regeneration studies. Exp Neurol. 2017 Jan;287(Pt 3):348-357. doi: 10.1016/j.expneurol.2016.04.011. Epub 2016 Apr 17.
PubMed 27094121Ursu DC, Urbanchek MG, Nedic A, Cederna PS, Gillespie RB. In vivo characterization of regenerative peripheral nerve interface function. J Neural Eng. 2016 Apr;13(2):026012. doi: 10.1088/1741-2560/13/2/026012. Epub 2016 Feb 9.
PubMed 26859115Giladi AM, McGlinn EP, Shauver MJ, Voice TP, Chung KC. Measuring outcomes and determining long-term disability after revision amputation for treatment of traumatic finger and thumb amputation injuries. Plast Reconstr Surg. 2014 Nov;134(5):746e-755e. doi: 10.1097/PRS.0000000000000591.
PubMed 25347649Langhals NB, Woo SL, Moon JD, Larson JV, Leach MK, Cederna PS, Urbanchek MG. Electrically stimulated signals from a long-term Regenerative Peripheral Nerve Interface. Annu Int Conf IEEE Eng Med Biol Soc. 2014;2014:1989-92. doi: 10.1109/EMBC.2014.6944004.
PubMed 25570372Frost CM, Cederna PS, Martin DC, Shim BS, Urbanchek MG. Decellular biological scaffold polymerized with PEDOT for improving peripheral nerve interface charge transfer. Annu Int Conf IEEE Eng Med Biol Soc. 2014;2014:422-5. doi: 10.1109/EMBC.2014.6943618.
PubMed 25569986Woo SL, Urbanchek MG, Cederna PS, Langhals NB. Revisiting nonvascularized partial muscle grafts: a novel use for prosthetic control. Plast Reconstr Surg. 2014 Aug;134(2):344e-346e. doi: 10.1097/PRS.0000000000000317. No abstract available.
PubMed 25068369Kung TA, Langhals NB, Martin DC, Johnson PJ, Cederna PS, Urbanchek MG. Regenerative peripheral nerve interface viability and signal transduction with an implanted electrode. Plast Reconstr Surg. 2014 Jun;133(6):1380-1394. doi: 10.1097/PRS.0000000000000168.
PubMed 24867721Kung TA, Bueno RA, Alkhalefah GK, Langhals NB, Urbanchek MG, Cederna PS. Innovations in prosthetic interfaces for the upper extremity. Plast Reconstr Surg. 2013 Dec;132(6):1515-1523. doi: 10.1097/PRS.0b013e3182a97e5f.
PubMed 24281580Hooper RC, Cederna PS, Brown DL, Haase SC, Waljee JF, Egeland BM, Kelley BP, Kung TA. Regenerative Peripheral Nerve Interfaces for the Management of Symptomatic Hand and Digital Neuromas. Plast Reconstr Surg Glob Open. 2020 Jun 4;8(6):e2792. doi: 10.1097/GOX.0000000000002792. eCollection 2020 Jun.
PubMed 32766027Svientek SR, Ursu DC, Cederna PS, Kemp SWP. Fabrication of the Composite Regenerative Peripheral Nerve Interface (C-RPNI) in the Adult Rat. J Vis Exp. 2020 Feb 25;(156):10.3791/60841. doi: 10.3791/60841.
PubMed 32176203Vu PP, Vaskov AK, Irwin ZT, Henning PT, Lueders DR, Laidlaw AT, Davis AJ, Nu CS, Gates DH, Gillespie RB, Kemp SWP, Kung TA, Chestek CA, Cederna PS. A regenerative peripheral nerve interface allows real-time control of an artificial hand in upper limb amputees. Sci Transl Med. 2020 Mar 4;12(533):eaay2857. doi: 10.1126/scitranslmed.aay2857.
PubMed 32132217Frost CM, Ursu DC, Flattery SM, Nedic A, Hassett CA, Moon JD, Buchanan PJ, Brent Gillespie R, Kung TA, Kemp SWP, Cederna PS, Urbanchek MG. Regenerative peripheral nerve interfaces for real-time, proportional control of a Neuroprosthetic hand. J Neuroeng Rehabil. 2018 Nov 20;15(1):108. doi: 10.1186/s12984-018-0452-1.
PubMed 30458876
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regenerative Peripheral Nerve Interfaces to Treat Painful Digit and Hand Neuromas After Amputation: A Prospective Observational Trial"
- ClinicalTrials.gov ID
- NCT05008185
- Acronym / sponsor ID
- Pro00049513
- Conditions
- Neuroma
- Keywords
- Neuroma, Neuroma Pain, Finger Amputation, Hand Amputation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- United States Department of Defense, University of Michigan
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 17 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regenerative Peripheral Nerve Interface | – | Procedure: Regenerative Peripheral Nerve Interface (RPNI) surgerysymptomatic neuroma is excised, and the end of the peripheral nerve is implanted into a small denervated free muscle graft harvested from the patient |
| Traction Neurectomy | – | Procedure: Traction Neurectomysimple excision and traction neurectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regenerative Peripheral Nerve Interface (RPNI) surgerySurgeons will perform neuroma resection and RPNI creation using a free muscle graft from the brachioradialis muscle harvested through a small separate incision | Procedure or surgery | Regenerative Peripheral Nerve Interface |
| Traction NeurectomySurgeons will perform neuroma resection and traction neurectomy, | Procedure or surgery | Traction Neurectomy |
Primary outcome
Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI)
Time frame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months
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)
Time frame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months
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
Time frame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months
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),
Time frame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months
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.
Generalized Anxiety Disorder measure (GAD-7),
Time frame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months
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.
PC-PTSD-5
Time frame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months
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.
13 secondary outcomes
PROMIS UpperExtremity (UE)
Time frame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months
Brief Michigan Hand Outcomes Questionnaire (bMHQ)
Time frame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months
Grip Strength
Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months
Pinch Strength -Key and Three-point
Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months
Range of Motion
Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months
Fine Motor Function - 9-Hole Peg Test (9HPT)
Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months
FunctionalTask Testing - Lifting boxes
Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months
Functional Task Testing - Carrying Boxes
Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months
Functional Task Testing - Push/Pull sled
Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months
Functional Task Testing - Hammer
Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months
Functional Task Testing - Vice Grip
Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months
Functional Task Testing - Gear Shifting
Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months
Functional Task Testing - Weapon Recoil
Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Background: PubMed 28293490Woo SL, Kung TA, Brown DL, Leonard JA, Kelly BM, Cederna PS. Regenerative Peripheral Nerve Interfaces for the Treatment of Postamputation Neuroma Pain: A Pilot Study. Plast Reconstr Surg Glob Open. 2016 Dec 27;4(12):e1038. doi: 10.1097/GOX.0000000000001038. eCollection 2016 Dec.
- Background: PubMed 27294122Urbanchek MG, Kung TA, Frost CM, Martin DC, Larkin LM, Wollstein A, Cederna PS. Development of a Regenerative Peripheral Nerve Interface for Control of a Neuroprosthetic Limb. Biomed Res Int. 2016;2016:5726730. doi: 10.1155/2016/5726730. Epub 2016 May 17.
- Background: PubMed 32115057Santosa KB, Oliver JD, Cederna PS, Kung TA. Regenerative Peripheral Nerve Interfaces for Prevention and Management of Neuromas. Clin Plast Surg. 2020 Apr;47(2):311-321. doi: 10.1016/j.cps.2020.01.004. Epub 2020 Feb 1.
- Background: PubMed 27094121Kemp SW, Cederna PS, Midha R. Comparative outcome measures in peripheral regeneration studies. Exp Neurol. 2017 Jan;287(Pt 3):348-357. doi: 10.1016/j.expneurol.2016.04.011. Epub 2016 Apr 17.
- Background: PubMed 26859115Ursu DC, Urbanchek MG, Nedic A, Cederna PS, Gillespie RB. In vivo characterization of regenerative peripheral nerve interface function. J Neural Eng. 2016 Apr;13(2):026012. doi: 10.1088/1741-2560/13/2/026012. Epub 2016 Feb 9.
- Background: PubMed 25347649Giladi AM, McGlinn EP, Shauver MJ, Voice TP, Chung KC. Measuring outcomes and determining long-term disability after revision amputation for treatment of traumatic finger and thumb amputation injuries. Plast Reconstr Surg. 2014 Nov;134(5):746e-755e. doi: 10.1097/PRS.0000000000000591.
- Background: PubMed 25570372Langhals NB, Woo SL, Moon JD, Larson JV, Leach MK, Cederna PS, Urbanchek MG. Electrically stimulated signals from a long-term Regenerative Peripheral Nerve Interface. Annu Int Conf IEEE Eng Med Biol Soc. 2014;2014:1989-92. doi: 10.1109/EMBC.2014.6944004.
- Background: PubMed 25569986Frost CM, Cederna PS, Martin DC, Shim BS, Urbanchek MG. Decellular biological scaffold polymerized with PEDOT for improving peripheral nerve interface charge transfer. Annu Int Conf IEEE Eng Med Biol Soc. 2014;2014:422-5. doi: 10.1109/EMBC.2014.6943618.
- Background: PubMed 25068369Woo SL, Urbanchek MG, Cederna PS, Langhals NB. Revisiting nonvascularized partial muscle grafts: a novel use for prosthetic control. Plast Reconstr Surg. 2014 Aug;134(2):344e-346e. doi: 10.1097/PRS.0000000000000317. No abstract available.
- Background: PubMed 24867721Kung TA, Langhals NB, Martin DC, Johnson PJ, Cederna PS, Urbanchek MG. Regenerative peripheral nerve interface viability and signal transduction with an implanted electrode. Plast Reconstr Surg. 2014 Jun;133(6):1380-1394. doi: 10.1097/PRS.0000000000000168.
- Background: PubMed 24281580Kung TA, Bueno RA, Alkhalefah GK, Langhals NB, Urbanchek MG, Cederna PS. Innovations in prosthetic interfaces for the upper extremity. Plast Reconstr Surg. 2013 Dec;132(6):1515-1523. doi: 10.1097/PRS.0b013e3182a97e5f.
- Background: PubMed 32766027Hooper RC, Cederna PS, Brown DL, Haase SC, Waljee JF, Egeland BM, Kelley BP, Kung TA. Regenerative Peripheral Nerve Interfaces for the Management of Symptomatic Hand and Digital Neuromas. Plast Reconstr Surg Glob Open. 2020 Jun 4;8(6):e2792. doi: 10.1097/GOX.0000000000002792. eCollection 2020 Jun.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aviram M Giladi, MS, MD principal investigator
Medstar Union Memorial Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroma, run by Medstar Health Research Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isaac C Fleming (410-554-2486, ike.c.fleming@medstar.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI) (time frame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05008185, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.