An interventional study of Peripheral Nerve Regenerative Interface (RPNI) and Nerve/Muscle Biopsy and Biopsy Alone in Neuroma of Lower Limb, sponsored by University of British Columbia. Not yet recruiting at 3 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-01.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
The purpose of our project is to determine if incorporating preventative surgical techniques such as regenerative peripheral nerve interfaces (RPNI) into sural nerve biopsy can reduce the incidence of symptomatic neuroma formation. Findings from this study will inform best practice guidelines and can dramatically impact patient care, improve patient quality of life, and reduce the number of required repeat operations.
Neuromas are a known complication from traumatic injury or surgery, including nerve biopsies. Neuromas are formed by non-neoplastic aberrant proliferation of injured nerves that cannot innervate an end target resulting in a neuroma bulb made of free nerve ends, fibrotic tissue, and blood vessels. Neuromas can cause significant, debilitating pain resulting in decreased quality of life for patients and potential repeat operative interventions. The incidence rate of neuroma formation following injury is not well described but previous literature reports rates up to 30% with 14% of patients requiring repeat operation. In order to address this problem, numerous preventative and therapeutic measures have been explored. Nonsurgical management options such as desensitization, anesthetic and/or steroid injections, analgesia, and nerve stimulation have yielded mixed results.10 Therefore there is a need for reproducible and reliable prevention and treatment strategies for painful neuroma. Currently, the main surgical interventions consist of targeted muscle reinnervation (TMR) and regenerative peripheral nerve interface (RPNI). In TMR, free nerve ends are transferred onto recipient motor nerves, whereas in RPNI, free nerve ends are wrapped in a free muscle graft. Both methods provide denervated muscle targets for nerve ends. Compared to TMR, and other microsurgical measures such as primary repair or nerve grafting, RPNI is a much simpler operation that can easily be performed in the minor procedures or ward setting where nerve biopsies are usually completed. Given the functional impact from painful neuromas and subsequent burden on operative resources, efforts should be taken to prevent neuroma formation with RPNI at time of biopsy. Our project could directly improve patient care by substantiating the need for preventative measures for neuroma formation during for sural nerve biopsy thereby changing the standard of care. Given the significant pain, decreased quality of life, and need for repeat interventions, incorporating RPNI could have dramatic impacts on patient care and reduce operative and resources burdens.
70 studies on the registry are indexed under Neuroma; 12 are open to participants now.
This study's planned enrollment of 20 is below the median of 33 across 49 interventional studies indexed under Neuroma.
Browse Neuroma studies →University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
Patients in this group will only undergo sural nerve and muscle biopsy
Procedure: Biopsy Alone
Patients in this group will undergo RPNI during their sural nerve and muscle biopsy
Procedure: Peripheral Nerve Regenerative Interface (RPNI) and Nerve/Muscle Biopsy
RPNI is a surgical technique which wraps denervated muscle targets around severed nerve ends.
Sural nerve and muscle biopsy performed in the standard fashion.
Symptomatic neuroma formation (sensation)
Change From Baseline in Subjective Sensation on a 10-Point Scale at 6 Months
Time frame: 6 months post-op
Symptomatic neuroma formation (pain)
Change From Baseline in Pain Scores on the Numerical Pain Rating Scale at 6 Months
Time frame: 6 months
Plan to share: No
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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University of British Columbia