Targeted Reinnervation as a Means to Treat Neuromas Associated With Major Limb Amputation



Status:Completed
Conditions:Chronic Pain, Podiatry
Therapuetic Areas:Musculoskeletal, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:1/5/2018
Start Date:October 2014
End Date:January 1, 2018

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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.

Loss of an arm or leg is a significant injury that affects a person's job prospects, personal
relationships, and overall quality of life. Approximately 25% of all amputees will develop
chronic local pain in the remaining part of their amputated limb. This pain is caused by
neuromas- disorganized nerve endings and scar tissue that form when an injured nerve tries to
heal. Every cut nerve will develop a neuroma unless the two ends of the nerve can be
rejoined. With limb amputation, the nerves are cut and one end is lost with the limb,
preventing the nerve from repairing itself. Instead, the cut nerve ending forms a painful
neuroma. Chronic pain from neuromas is a major reason that amputees cannot wear or use their
prostheses comfortably and increases their disability. The current standard surgical
treatment for a neuroma is to cut if off and bury the nerve ending in a muscle, to provide
cushioning when the neuroma grows back. Even though this is the best current treatment, it is
not always successful.

Even when a limb is amputated, the nerves that used to control that limb still carry messages
from the brain. Those messages are intended to tell the muscles how or when to move the
missing limb, but after amputation, these limb-control nerves are no longer connected to
muscles. In 2002, researchers at Northwestern Memorial Hospital in conjunction with the
Rehabilitation Institute of Chicago developed a new type of surgery called targeted muscle
reinnervation (TMR). In TMR, limb-control nerves are transferred so that they can control new
target muscles. The neuromas from the limb-control nerves are removed, then the small nerve
that controls the target muscle is cut. The two nerves are joined together so that the
limb-control nerve can then grow into, or reinnervate the target muscle. After TMR, when the
person tries to move the missing limb, the target muscle contracts instead and these signals
can be detected and used to control a prosthesis. TMR has now been done successfully almost
100 times worldwide. Interestingly, almost all of the patients who had painful neuromas
before TMR had no neuroma pain after surgery. This result was investigated in laboratory
studies - both rat and rabbit amputee neuromas were "cured" with TMR. We think that giving
the cut nerve endings somewhere to go and something to do prevents a neuroma from forming.

We plan to compare TMR versus the current standard surgical treatment for painful neuromas.
We will measure the effectiveness of both surgeries using an internet-based amputee pain
questionnaire. We will also use magnetic resolution imaging (MRI) to look at the nerves
before and after surgery. We have received a grant to complete a 4 year study in four
hospitals across the US, in around 200 patients, making this the largest neuroma study ever
performed. We expect that TMR will be significantly more effective for neuroma pain than the
standard treatment. This will change how patients with neuroma pain are treated and help
thousands of patients with amputations.

Inclusion Criteria:

- Adult, 18 years or older: the Patient Reported Outcomes Measurement Information System
(PROMIS) questionnaire is not validated for pain-related evaluation in minors

- An upper limb amputation above the wrist with or without a residual limb or a lower
limb amputation above the ankle with a residual limb (individuals with a hip
disarticulation amputation lack suitable target muscles for TR)

- A neuroma within the residual limb: defined as patient-reported chronic localized pain
consistent with a physical exam that demonstrates that the pain is related to a cut
nerve and excludes other causes. There must be a supporting Tinel's sign on physical
exam, MRI findings suggestive of a neuroma, or localization of a neuroma by prior
intervention (surgical or otherwise) to distinguish the pain from phantom limb pain or
cold intolerance that are nonspecific signs of nerve damage that would not be affected
by treatment of a neuroma.

- English or Spanish speaking: the PROMIS questionnaire is available in English and
parts are currently available in Spanish. The portions that are currently unavailable
in Spanish will be translated into Spanish for the purposes of this study.

Exclusion Criteria:

- Prior TR Surgery: these patients have already had a procedure to improve their
prosthetic function and in these cases the nerves have been shortened. To perform a
second TR procedure with the previously shortened nerves would require a significant
proximal dissection and potentially greater soft tissue morbidity than the standard
treatment.

- Cognitive impairment, due to TBI or other causes, sufficient to adversely affect
understanding of or compliance with study requirements, ability to respond to
questionnaires, or ability to give informed consent: The ability to understand and
comply with requirements of the study is essential in order for the study to generate
useable, reliable data. The ability to obtain relevant feedback through questionnaires
is essential to this study.

- Pre-operative assessment that precludes the patient from being eligible for TR or
control surgery due to technical surgical concerns.

- Significant other comorbidity: Any other medical issues or injuries that would
preclude safe administration of anesthesia or surgical intervention.

- Participation in other ongoing studies related to neuropathic pain.
We found this trial at
6
sites
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Phone: 615-343-8426
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Phone: 301-400-2727
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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Bethesda, MD
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Gregory A Dumanian, MD
Phone: 312-695-6022
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Chicago, IL
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Phone: 614-293-8566
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, OH
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
Phone: 405-271-4426
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Oklahoma City, OK
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San Antonio, Texas
Principal Investigator: Mickey Cho, MD
Phone: 210-859-4207
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San Antonio, TX
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