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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 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 27 participants.

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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.

Interventions

  • PROCEDURE Targeted Muscle Reinnervation
  • PROCEDURE Traction Neurectomy

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2014-10
Est. Completion 2018-01-01
Phase NA

Sponsor

Northwestern University

1,209 total trials

What the Registry Record Tells You About NCT02205385

The ClinicalTrials.gov registry entry for NCT02205385 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Targeted Muscle Reinnervation is the first listed.

NCT02205385 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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