Amputation NeuromaNCT05554900
The Efficacy of Preventive Regenerative Peripheral Nerve Interface(RPNI) Reconstruction in Amputees
A study testing preventive regenerative peripheral nerve interface reconstruction in people with Amputation Neuroma, run by Peking University People's Hospital at 1 site in China.
Trial summary
The trial will be carried out in Peking University People's Hospital. The whole trial will last 3 years. Amputees from orthopedics and vascular surgery will be distributed into two groups randomly and receive different treatments including traditional resection and regenerative peripheral nerve interface(RPNI)… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Amputation Neuroma
- What is being tested?
- preventive regenerative peripheral nerve interface reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Perform traditional amputation and nerve disconnection or RPNIs in Peking University People's Hospital
- Age≥6 years
- Follow-up time≥12 weeks
Who cannot join
- Follow-up time<12 weeks
- Age<6 years
- Preoperative complications included cervical spondylosis, lumbar spinal stenosis, piriformis syndrome, cubital tunnel syndrome and other peripheral nerve entrapment syndrome
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing
Guangxue Li, 13581763702, luckylgx1012@163.com
About this study
Official title: The Efficacy, Safety and Prognosis of Preventive Regenerative Peripheral Nerve Interface(RPNI) Reconstruction in Amputees: Study Protocol for a Cohort Study
The trial will be carried out in Peking University People's Hospital. The whole trial will last 3 years. Amputees from orthopedics and vascular surgery will be distributed into two groups randomly and receive different treatments including traditional resection and regenerative peripheral nerve interface(RPNI) surgery.The pain outcome,the impact of post-amputation pain on life and the utilization rate of prostheses will be collected to study the efficacy, safety and prognosis of preventive regenerative peripheral nerve interface reconstruction in amputees.
Investigators believe that RPNI can effectively reduce the incidence of post-amputation pain, reduce the degree of pain, improve the wearing rate of prostheses, and help patients return to normal life.
- Conditions
- Amputation Neuroma
- Being tested
- preventive regenerative peripheral nerve interface reconstruction
- Keywords
- Amputation, Regenerative peripheral nerve interface, Neuroma
- Medical subject headings
- Neuroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preventive regenerative peripheral nerve interface reconstructionProcedure or surgery
Each RPNI unit consists of nerve stump and free autologous muscle graft that is cut off from healthy muscle of the amputated limb. The muscle graft is approximately 30×15×5 mm.The ends of the transected nerve are placed within the muscle belly of the free muscle grafts in an orientation that is parallel to the muscle fibers. Next, the nerve is secured distally with 6-0 non-absorbable monofilament sutures in an epimysial-to-epineurial fashion. The nerve is then wrapped around completely via muscle graft and epimysial securing sutures. All RPNI units are placed in areas remote from the surgical incision and from the weight-bearing surface of the limb.
| Study group | Role | What they receive |
|---|---|---|
| The control group | No intervention | The control group received traditional amputation.The proximal nerve is blocked with lidocaine and cut off. The end of the nerve retracted as far as possible and the bleeding point is ligated if necessary. |
| The experimental group（RPNIs group） | Experimental | The experimental group received regenerative peripheral nerve interface（RPNI） surgery. Receives: Procedure: preventive regenerative peripheral nerve interface reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
postamputation pain
Patient-Reported Outcomes Measurement Information System (NRS, PROMIS) were used to assess postamputation pain.The intensity of pain is described by 11 points from 0 (painless) to 10 (the most severe pain).
Measured: 12 weeks at least after surgery
Secondary outcomes (3)
Prosthesis wearing
Whether the subject wears a prosthetic limb, and if so, what kind of prosthetic limb is worn.
Measured: 12 weeks at least after surgery
Tumor recurrence and metastasis
Whether there is tumor recurrence or metastasis.
Measured: 12 weeks at least after surgery
Quality of life
The medical outcomes study-short from(MOS-SF 36) is used to evaluate the difference between the RPNIs group and the control group in the quality of life after amputation.The SF-36 scale consists of 36 questions with eight dimensions:physiological function, role-physiological, physical pain, general health, vitality, social function, role-emotional, and mental health. The scoring method was used for each dimension, ranging from 0 to 100 points. The higher the score, the better the health status.
Measured: 12 weeks at least after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start12 May 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Amputation NeuromaStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Guangxue, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554900
- Sponsor's protocol ID
- lgx2022
- Status last verified
- Sep 2022
- First submitted
- 3 Sep 2022
- Last updated
- 26 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Watson J, Gonzalez M, Romero A, Kerns J. Neuromas of the hand and upper extremity. J Hand Surg Am. 2010 Mar;35(3):499-510. doi: 10.1016/j.jhsa.2009.12.019.
PubMed 20193866Zimmermann M. Pathobiology of neuropathic pain. Eur J Pharmacol. 2001 Oct 19;429(1-3):23-37. doi: 10.1016/s0014-2999(01)01303-6.
PubMed 11698024Bowsher D. Human "autotomy". Pain. 2002 Jan;95(1-2):187-9. doi: 10.1016/s0304-3959(01)00389-x.
PubMed 11790481Niederberger E, Kuhlein H, Geisslinger G. Update on the pathobiology of neuropathic pain. Expert Rev Proteomics. 2008 Dec;5(6):799-818. doi: 10.1586/14789450.5.6.799.
PubMed 19086860McFarland LV, Hubbard Winkler SL, Heinemann AW, Jones M, Esquenazi A. Unilateral upper-limb loss: satisfaction and prosthetic-device use in veterans and servicemembers from Vietnam and OIF/OEF conflicts. J Rehabil Res Dev. 2010;47(4):299-316. doi: 10.1682/jrrd.2009.03.0027.
PubMed 20803400Davis RW. Phantom sensation, phantom pain, and stump pain. Arch Phys Med Rehabil. 1993 Jan;74(1):79-91.
PubMed 8380543Vlot MA, Wilkens SC, Chen NC, Eberlin KR. Symptomatic Neuroma Following Initial Amputation for Traumatic Digital Amputation. J Hand Surg Am. 2018 Jan;43(1):86.e1-86.e8. doi: 10.1016/j.jhsa.2017.08.021. Epub 2017 Sep 23.
PubMed 28951100Ives GC, Kung TA, Nghiem BT, Ursu DC, Brown DL, Cederna PS, Kemp SWP. Current State of the Surgical Treatment of Terminal Neuromas. Neurosurgery. 2018 Sep 1;83(3):354-364. doi: 10.1093/neuros/nyx500.
PubMed 29053875Poppler LH, Parikh RP, Bichanich MJ, Rebehn K, Bettlach CR, Mackinnon SE, Moore AM. Surgical interventions for the treatment of painful neuroma: a comparative meta-analysis. Pain. 2018 Feb;159(2):214-223. doi: 10.1097/j.pain.0000000000001101.
PubMed 29189515Barbour JR, Yee A, Moore AM, Trulock EP, Buchowski JM, Mackinnon SE. Cadaveric nerve allotransplantation in the treatment of persistent thoracic neuralgia. Ann Thorac Surg. 2015 Apr;99(4):1414-7. doi: 10.1016/j.athoracsur.2014.06.092.
PubMed 25841822Elliot D. Surgical management of painful peripheral nerves. Clin Plast Surg. 2014 Jul;41(3):589-613. doi: 10.1016/j.cps.2014.03.004.
PubMed 24996473Lipinski LJ, Spinner RJ. Neurolysis, neurectomy, and nerve repair/reconstruction for chronic pain. Neurosurg Clin N Am. 2014 Oct;25(4):777-87. doi: 10.1016/j.nec.2014.07.002. Epub 2014 Aug 14.
PubMed 25240664Kuiken TA, Miller LA, Lipschutz RD, Lock BA, Stubblefield K, Marasco PD, Zhou P, Dumanian GA. Targeted reinnervation for enhanced prosthetic arm function in a woman with a proximal amputation: a case study. Lancet. 2007 Feb 3;369(9559):371-80. doi: 10.1016/S0140-6736(07)60193-7.
PubMed 17276777Peters BR, Russo SA, West JM, Moore AM, Schulz SA. Targeted muscle reinnervation for the management of pain in the setting of major limb amputation. SAGE Open Med. 2020 Sep 15;8:2050312120959180. doi: 10.1177/2050312120959180. eCollection 2020.
PubMed 32974021Santosa KB, Oliver JD, Cederna PS, Kung TA. Regenerative Peripheral Nerve Interfaces for Prevention and Management of Neuromas. Clin Plast Surg. 2020 Apr;47(2):311-321. doi: 10.1016/j.cps.2020.01.004. Epub 2020 Feb 1.
PubMed 32115057
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy, Safety and Prognosis of Preventive Regenerative Peripheral Nerve Interface(RPNI) Reconstruction in Amputees: Study Protocol for a Cohort Study
- ClinicalTrials.gov ID
- NCT05554900
- Acronym / sponsor ID
- lgx2022
- Conditions
- Amputation Neuroma
- Keywords
- Amputation, Regenerative peripheral nerve interface, Neuroma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 12 May 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 26 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial will be carried out in Peking University People's Hospital. The whole trial will last 3 years. Amputees from orthopedics and vascular surgery will be distributed into two groups randomly and receive different treatments including traditional resection and regenerative peripheral nerve interface(RPNI) surgery.The pain outcome,the impact of post-amputation pain on life and the utilization rate of prostheses will be collected to study the efficacy, safety and prognosis of preventive regenerative peripheral nerve interface reconstruction in amputees.
Investigators believe that RPNI can effectively reduce the incidence of post-amputation pain, reduce the degree of pain, improve the wearing rate of prostheses, and help patients return to normal life.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The control group | No intervention | –The control group received traditional amputation.The proximal nerve is blocked with lidocaine and cut off. The end of the nerve retracted as far as possible and the bleeding point is ligated if necessary. |
| The experimental group（RPNIs group） | Experimental | Procedure: preventive regenerative peripheral nerve interface reconstructionThe experimental group received regenerative peripheral nerve interface（RPNI） surgery. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Perform traditional amputation and nerve disconnection or RPNIs in Peking University People's Hospital
- Age≥6 years
- Follow-up time≥12 weeks
Key exclusion criteria (3 listed)
- Follow-up time<12 weeks
- Age<6 years
- Preoperative complications included cervical spondylosis, lumbar spinal stenosis, piriformis syndrome, cubital tunnel syndrome and other peripheral nerve entrapment syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preventive regenerative peripheral nerve interface reconstructionEach RPNI unit consists of nerve stump and free autologous muscle graft that is cut off from healthy muscle of the amputated limb. The muscle graft is approximately 30×15×5 mm.The ends of the transected nerve are placed within the muscle belly of the free muscle grafts in an orientation that is parallel to the muscle fibers. Next, the nerve is secured distally with 6-0 non-absorbable monofilament sutures in an epimysial-to-epineurial fashion. The nerve is then wrapped around completely via muscle graft and epimysial securing sutures. All RPNI units are placed in areas remote from the surgical incision and from the weight-bearing surface of the limb. | Procedure or surgery | The experimental group（RPNIs group） |
Primary outcome
postamputation pain
Time frame: 12 weeks at least after surgery
Patient-Reported Outcomes Measurement Information System (NRS, PROMIS) were used to assess postamputation pain.The intensity of pain is described by 11 points from 0 (painless) to 10 (the most severe pain).
3 secondary outcomes
Prosthesis wearing
Time frame: 12 weeks at least after surgery
Tumor recurrence and metastasis
Time frame: 12 weeks at least after surgery
Quality of life
Time frame: 12 weeks at least after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- Background: PubMed 20193866Watson J, Gonzalez M, Romero A, Kerns J. Neuromas of the hand and upper extremity. J Hand Surg Am. 2010 Mar;35(3):499-510. doi: 10.1016/j.jhsa.2009.12.019.
- Background: PubMed 11698024Zimmermann M. Pathobiology of neuropathic pain. Eur J Pharmacol. 2001 Oct 19;429(1-3):23-37. doi: 10.1016/s0014-2999(01)01303-6.
- Background: PubMed 11790481Bowsher D. Human "autotomy". Pain. 2002 Jan;95(1-2):187-9. doi: 10.1016/s0304-3959(01)00389-x.
- Background: PubMed 19086860Niederberger E, Kuhlein H, Geisslinger G. Update on the pathobiology of neuropathic pain. Expert Rev Proteomics. 2008 Dec;5(6):799-818. doi: 10.1586/14789450.5.6.799.
- Background: PubMed 20803400McFarland LV, Hubbard Winkler SL, Heinemann AW, Jones M, Esquenazi A. Unilateral upper-limb loss: satisfaction and prosthetic-device use in veterans and servicemembers from Vietnam and OIF/OEF conflicts. J Rehabil Res Dev. 2010;47(4):299-316. doi: 10.1682/jrrd.2009.03.0027.
- Background: PubMed 8380543Davis RW. Phantom sensation, phantom pain, and stump pain. Arch Phys Med Rehabil. 1993 Jan;74(1):79-91.
- Background: PubMed 28951100Vlot MA, Wilkens SC, Chen NC, Eberlin KR. Symptomatic Neuroma Following Initial Amputation for Traumatic Digital Amputation. J Hand Surg Am. 2018 Jan;43(1):86.e1-86.e8. doi: 10.1016/j.jhsa.2017.08.021. Epub 2017 Sep 23.
- Background: PubMed 29053875Ives GC, Kung TA, Nghiem BT, Ursu DC, Brown DL, Cederna PS, Kemp SWP. Current State of the Surgical Treatment of Terminal Neuromas. Neurosurgery. 2018 Sep 1;83(3):354-364. doi: 10.1093/neuros/nyx500.
- Background: PubMed 29189515Poppler LH, Parikh RP, Bichanich MJ, Rebehn K, Bettlach CR, Mackinnon SE, Moore AM. Surgical interventions for the treatment of painful neuroma: a comparative meta-analysis. Pain. 2018 Feb;159(2):214-223. doi: 10.1097/j.pain.0000000000001101.
- Background: PubMed 25841822Barbour JR, Yee A, Moore AM, Trulock EP, Buchowski JM, Mackinnon SE. Cadaveric nerve allotransplantation in the treatment of persistent thoracic neuralgia. Ann Thorac Surg. 2015 Apr;99(4):1414-7. doi: 10.1016/j.athoracsur.2014.06.092.
- Background: PubMed 24996473Elliot D. Surgical management of painful peripheral nerves. Clin Plast Surg. 2014 Jul;41(3):589-613. doi: 10.1016/j.cps.2014.03.004.
- Background: PubMed 25240664Lipinski LJ, Spinner RJ. Neurolysis, neurectomy, and nerve repair/reconstruction for chronic pain. Neurosurg Clin N Am. 2014 Oct;25(4):777-87. doi: 10.1016/j.nec.2014.07.002. Epub 2014 Aug 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preventive regenerative peripheral nerve interface reconstruction in people with Amputation Neuroma, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guangxue Li (13581763702, luckylgx1012@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postamputation pain (time frame: 12 weeks at least after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05554900, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2022.