Targeted Reinnervation for Neuromas as a Means to Improve Prosthesis Control in Major Limb Amputation

Completed · Not applicable

Conditions studied: Neuroma, Pain, Prosthesis User, Prosthesis Failure

In brief

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). The investigators are studying how targeted reinnervation (TR) helps to both treat neuroma pain and to have increased prosthetic control. 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. The investigators, therefore, are conducting this clinical trial. The investigators 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 amputee will allow us to understand how to best improve neuroma pain and prosthesis control. 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.

Key facts

Study ID

NCT02316262

Run by

Northwestern University

People needed

33

Starts

2014-10-01

Expected to finish

2018-01-01

Last updated by the study team

2018-01-03

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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
• 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, 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

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.

Where it is running

• Northwestern University — Chicago, Illinois, United States
• Walter Reed National Military Medical Center — Bethesda, Maryland, United States
• The Ohio State University — Columbus, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• San Antonio Military Medical Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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