Does RPNI Reduce Incidence of Neuroma Formation Following Sural Nerve Biopsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Peripheral Nerve Regenerative Interface (RPNI) and Nerve/Muscle Biopsy, Biopsy Alone.
- Who it may be relevant to
- Registry conditions: Neuroma of Lower Limb. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Does RPNI Reduce Incidence of Neuroma Formation Following Sural Nerve Biopsy: a Pilot Study
Overview
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.
Detailed description
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.
Interventions
- Procedure Peripheral Nerve Regenerative Interface (RPNI) and Nerve/Muscle Biopsy
RPNI is a surgical technique which wraps denervated muscle targets around severed nerve ends. - Procedure Biopsy Alone
Sural nerve and muscle biopsy performed in the standard fashion.
Primary outcome measures
- Symptomatic neuroma formation (sensation) [Time frame: 6 months post-op]
- Symptomatic neuroma formation (pain) [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Patient 18 years old and older who are referred for sural nerve and muscle biopsy to the University of British Columbia Division of Plastic Surgery from January 2025 onwards for diagnostic or prognostic clarification of a medical condition.
Exclusion criteria
- Patients with previous nerve trauma (traumatic injury, surgery, or repeat biopsy) of biopsied nerve.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Canada · 3 centers
- UBC Division of Plastic Surgery — Vancouver
- Vancouver General Hospital — Vancouver
- Saint Pauls Hospital — Vancouver
Publications
- Lans J, Gamo L, DiGiovanni CW, Chen NC, Eberlin KR. Etiology and Treatment Outcomes for Sural Neuroma. Foot Ankle Int. 2019 May;40(5):545-552. doi: 10.1177/1071100719828375. Epub 2019 Feb 2. PMID 30712380
- Radtke C, Kocsis JD, Reimers K, Allmeling C, Vogt PM. Sural nerve defects after nerve biopsy or nerve transfer as a sensory regeneration model for peripheral nerve conduit implantation. Med Hypotheses. 2013 Sep;81(3):500-2. doi: 10.1016/j.mehy.2013.06.020. Epub 2013 Jul 16. PMID 23867139
- Ducic I, Yoon J, Buncke G. Chronic postoperative complications and donor site morbidity after sural nerve autograft harvest or biopsy. Microsurgery. 2020 Sep;40(6):710-716. doi: 10.1002/micr.30588. Epub 2020 Apr 10. PMID 32277511
- Hilton DA, Jacob J, Househam L, Tengah C. Complications following sural and peroneal nerve biopsies. J Neurol Neurosurg Psychiatry. 2007 Nov;78(11):1271-2. doi: 10.1136/jnnp.2007.116368. Epub 2007 Jun 5. PMID 17550992
- Chang BL, Mondshine J, Fleury CM, Attinger CE, Kleiber GM. Incidence and Nerve Distribution of Symptomatic Neuromas and Phantom Limb Pain after Below-Knee Amputation. Plast Reconstr Surg. 2022 Apr 1;149(4):976-985. doi: 10.1097/PRS.0000000000008953. PMID 35188944
- Aslami ZV, Leland CR, Strike SA, Forsberg JA, Morris CD, Levin AS, Tuffaha SH. Symptomatic Neuroma Development following En Bloc Resection of Skeletal and Soft-Tissue Tumors: A Retrospective Analysis of 331 Cases. Plast Reconstr Surg. 2024 Apr 1;153(4):873-883. doi: 10.1097/PRS.0000000000010659. Epub 2023 May 18. PMID 37199679
- Cychosz CC, Eisenberg J, Glass N, Fleury I, Buckwalter V JA, Phisitkul P, Femino JE. Outcomes of Surgical Treatment for Sural Neuritis: A Retrospective Case Series. Foot Ankle Int. 2023 Sep;44(9):845-853. doi: 10.1177/10711007231184472. Epub 2023 Jul 21. PMID 37477149
- Leach GA, Dean RA, Kumar NG, Tsai C, Chiarappa FE, Cederna PS, Kung TA, Reid CM. Regenerative Peripheral Nerve Interface Surgery: Anatomic and Technical Guide. Plast Reconstr Surg Glob Open. 2023 Jul 17;11(7):e5127. doi: 10.1097/GOX.0000000000005127. eCollection 2023 Jul. PMID 37465283
Identifiers
NCT: NCT06754969 · H24-03129