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

NCT02205385 | Completed

• 2 other identifiers: TMR NeuromaOR120021
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Neuroma; Neuroma Amputation; Pain

Keywords

Neuroma; Amputee; Amputation Stump; Assessment, Pain

Outcome Measures

Primary Outcomes (1)

• Improvement in pain of the amputated limb after surgery

  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).

  12 months

Secondary Outcomes (2)

• Improvement in physical functioning, including prosthesis wear, after surgery

  12 months

• Using MRI as a tool to determine if targeted muscle reinnervation prevents neuroma recurrence

  1 year

Study Arms (2)

Traditional Traction Neurectomy

ACTIVE COMPARATOR

Patients will be randomized to either the current standard of care surgical treatment for neuromas (traction neurectomy) or the experimental intervention (targeted reinnervation). This arm involves the use of the current standard of care surgical treatment. Patients will undergo the same pre-operative evaluation, anesthesia, and dissection to identify the painful residual limb neuroma(s). In the active comparator arm, gentle traction will be applied to the nerve while excising the neuroma (traction neurectomy) allowing the nerve to retract more proximally. It may be buried in healthy muscle to further pad the nerve ending. The intention is to place the inevitable recurrent end-neuroma away from superficial locations in which it is likely to become mechanically irritated.

Procedure: Traction Neurectomy

Targeted Muscle Reinnervation

EXPERIMENTAL

Patients will be randomized to either the current standard of care surgical treatment for neuromas (traction neurectomy) or the experimental intervention (targeted reinnervation). This arm involves the use of the experimental surgical treatment. Patients will undergo the same pre-operative evaluation, anesthesia, and dissection to identify the painful residual limb neuroma(s). Targeted muscle reinnervation involves transfer of residual nerves to otherwise redundant target muscles. Native motor innervation of the target muscle is cut, and the residual nerves-after excision of end-neuromas-are coapted to the motor end point of the motor nerve, close to its point of entry into the muscle.

Procedure: Targeted Muscle Reinnervation

Interventions

Targeted Muscle Reinnervation PROCEDURE

Also known as: Targeted Reinnervation

Targeted Muscle Reinnervation

Traction Neurectomy PROCEDURE

Traditional Traction Neurectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead
• United States Department of Defense: collaborator

Study Sites (6)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-5600, United States

Location

The Ohio State University

Columbus, Ohio, 43212, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

San Antonio Military Medical Center

San Antonio, Texas, 78234, United States

Location

Related Publications (1)

• Dumanian GA, Potter BK, Mioton LM, Ko JH, Cheesborough JE, Souza JM, Ertl WJ, Tintle SM, Nanos GP, Valerio IL, Kuiken TA, Apkarian AV, Porter K, Jordan SW. Targeted Muscle Reinnervation Treats Neuroma and Phantom Pain in Major Limb Amputees: A Randomized Clinical Trial. Ann Surg. 2019 Aug;270(2):238-246. doi: 10.1097/SLA.0000000000003088.

  PMID: 30371518 DERIVED

MeSH Terms

Conditions

Neuroma; Pain

Condition Hierarchy (Ancestors)

Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery, Plastic and Reconstructive Surgery

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: July 31, 2014
• Study Start: October 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: January 3, 2018

Record last verified: 2018-01

Locations

US (6)