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NCT02205385 · ClinicalTrials.gov registry record · NA
Targeted Reinnervation as a Means to Treat Neuromas Associated With Major Limb Amputation
A NA study, sponsored by Northwestern University.
- Completed
- Registry status
- NA
- Development phase
- 27
- Enrollment target
NCT02205385: Completed NA study, sponsored by Northwestern University.
NCT02205385 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 27 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02205385, a NA study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- NA
- Development phase
- 27 participants
- Enrollment target
Study Summary
Subjects are being asked to participate in this study because they have an arm or leg amputation and have developed pain related to a neuroma (an ongoing localized pain related to a cut nerve ending). We are studying two different types of surgery to treat the neuroma pain. Today there are many surgical options reported which often means that there is no one best treatment. The surgery that shows the best success so far, involves cutting out the scarred nerve ending (neuroma) and burying the freshly cut nerve ending in a nearby muscle. Recently, a new surgery has been developed called targeted reinnervation (TR). This surgery connects these cut nerve endings to nerves going into nearby nonfunctional muscles. This surgery was developed to allow amputees to have better prosthesis control. By chance, neuroma pain improved significantly with TR. We, therefore, are conducting this clinical trial to evaluate which of these two surgeries best treats neuroma pain. We will ask all participants to fill out a questionnaire both before and after surgery. This will help us understand how a neuroma affects the quality of life of amputees and will allow us to understand which surgery leads to the best improvement in neuroma pain. In order to confirm the presence and location of the neuroma before surgery, a magnetic resonance image (MRI) will be performed. Taking these pictures requires subjects to lie still for a short period of time but does not involve any invasive procedures. After surgery, the MRI will be done again, this time to see if the nerve shows signs of scarring.
Primary Outcome
Difference in patient-reported pain scores before and after surgical treatment using the online survey tool. Compare patient-reported pre-operative survey results to those after surgical intervention at intervals over time (1 month, 3 months,6 months, 9 months,1 year, and then every six months thereafter until the conclusion of the study).
Interventions
- PROCEDURE Targeted Muscle Reinnervation
- PROCEDURE Traction Neurectomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2014-10 |
| Est. Completion | 2018-01-01 |
| Phase | NA |
What the finished NCT02205385 record still lists
NCT02205385 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Targeted Muscle Reinnervation is the first listed.
NCT02205385 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02205385 about?
NCT02205385 is a clinical study titled "Targeted Reinnervation as a Means to Treat Neuromas Associated With Major Limb Amputation". Subjects are being asked to participate in this study because they have an arm or leg amputation and have developed pain related to a neuroma (an ongoing localized pain related to a cut nerve ending). We are studying two different types of surgery to treat the neuroma pain. Today there are many sur...
What is the current status of trial NCT02205385?
This trial is currently completed. It is a NA study. The enrollment target is 27 participants. The study started on 2014-10. Estimated completion is 2018-01-01.
What interventions are being tested in trial NCT02205385?
The interventions under investigation include: Targeted Muscle Reinnervation (PROCEDURE), Traction Neurectomy (PROCEDURE).
Who is sponsoring clinical trial NCT02205385?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02205385's enrollment target sits among peer trials
27 1708th of 2000 higher than 291 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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