Regenerative Peripheral Nerve Interfaces for the Treatment of Painful Neuromas in Major Limb Amputees
NCT ID: NCT07285486
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
132 participants
OBSERVATIONAL
2017-06-08
2023-06-26
Brief Summary
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This investigation has a prospective cohort study design involving major lower limb amputees drawn from both the University of Michigan Health Systems and VA Health System of Ann Arbor. To objectively evaluate the effect of RPNI surgery on patients' perception of pain and to measure other health-related quality of life metrics relating to neuroma pain, this clinical trial will utilize specific, validated patient-reported outcomes measures (PROMs) to assess targeted domains in patients with major limb amputation. These survey instruments will determine: 1) patterns of pain medication use, including the use of opioids, 2) functional status and use of a prosthetic device, 3) changes in neuroma pain quality, 4) limitations in activities of daily living due to neuroma pain, 5) depression and anxiety relating to neuroma pain.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Chronic Amputation Pain
Participants who were existing amputees who had chronic neuroma pain at the amputation site.
Amputation with Regenerative Peripheral Nerve Interfaces (RPNI)
Free-muscle graft over cut nerve ends for treatment of neuromas at site of an amputation.
Prophylactic Treatment Group
Participants who had a lower extremity amputated during the study and were prophylactically treated for pain.
Amputation with Regenerative Peripheral Nerve Interfaces (RPNI)
Free-muscle graft over cut nerve ends for treatment of neuromas at site of an amputation.
Amputation Without RPNI
Standard of care for lower-extremity amputation
Interventions
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Amputation with Regenerative Peripheral Nerve Interfaces (RPNI)
Free-muscle graft over cut nerve ends for treatment of neuromas at site of an amputation.
Amputation Without RPNI
Standard of care for lower-extremity amputation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Symptomatic residual limb neuroma (chronic pain treatment group only)
* Undergoing a major lower limb amputation (prophylactic pain treatment group only)
Exclusion Criteria
* History of regenerative peripheral nerve interface (RPNI)
18 Years
ALL
No
Sponsors
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University of Michigan
OTHER
Responsible Party
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Theodore Alexander Kung
Principal Investogator
Principal Investigators
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Theodore Kung, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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Department of Veterans Affairs Ann Arbor Health System
Ann Arbor, Michigan, United States
University of Michigan
Ann Arbor, Michigan, United States
Countries
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References
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Lee JC, Kubiak CA, Best CSW, Hamill JB, Ki J, Kim HM, Roth RS, Kozlow JH, Tinney MJ, Geisser ME, Cederna PS, Kemp SWP, Kung TA. Regenerative Peripheral Nerve Interface Surgery to Treat Chronic Postamputation Pain: A Prospective Study in Major Lower Limb Amputation Patients. Ann Surg Open. 2025 Jan 7;6(1):e535. doi: 10.1097/AS9.0000000000000535. eCollection 2025 Mar.
Other Identifiers
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HUM00120915
Identifier Type: -
Identifier Source: org_study_id