Status:
COMPLETED
Targeted Reinnervation as a Means to Treat Neuromas Associated With Major Limb Amputation
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
United States Department of Defense
Conditions:
Neuroma
Neuroma Amputation
Eligibility:
All Genders
18+ years
Phase:
NA
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)....
Detailed Description
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2018
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT02205385
Start Date
October 1 2014
End Date
January 1 2018
Last Update
January 3 2018
Active Locations (6)
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1
Northwestern University
Chicago, Illinois, United States, 60611
2
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889-5600
3
The Ohio State University
Columbus, Ohio, United States, 43212
4
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104