| CTRI Number |
CTRI/2026/03/105812 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Randomized Controlled Study of Pain Outcomes in Post-Traumatic Lower Limb Amputations: Preemptive RPNI Versus Traction Neurectomy |
|
Scientific Title of Study
|
Comparing Pain Outcomes Following Preemptive
Regenerative Peripheral Nerve
Interface (RPNI) Versus Traction Neurectomy
in Post-Traumatic Lower Limb Amputations-
A Randomized Control Trial |
| Trial Acronym |
NILL
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhijit B R |
| Designation |
Senior Resident |
| Affiliation |
JPNATC, AIIMS, New Delhi |
| Address |
Division Of Trauma Surgery And Critical Care,
Department Of Surgical Disciplines,
Jai Prakash Narayan Apex Trauma Center, AIIMS, New Delhi
A1/273, Block A 1, Nauroji Nagar, Safdarjung Enclave
Division Of Trauma Surgery And Critical Care,
Department Of Surgical Disciplines,
Jai Prakash Narayan Apex Trauma Center, AIIMS, New Delhi
A1/273, Block A 1, Nauroji Nagar, Safdarjung Enclave
New Delhi
DELHI
110029
India |
| Phone |
9686354389 |
| Fax |
|
| Email |
br.alchemist@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhinav Kumar |
| Designation |
Assistant Professor |
| Affiliation |
JPNATC, AIIMS, New Delhi |
| Address |
Division Of Trauma Surgery And Critical Care,
Department Of Surgical Disciplines,
Jai Prakash Narayan Apex Trauma Center, AIIMS, New Delhi
A1/273, Block A 1, Nauroji Nagar, Safdarjung Enclave
Division Of Trauma Surgery And Critical Care,
Department Of Surgical Disciplines,
Jai Prakash Narayan Apex Trauma Center, AIIMS, New Delhi
A1/273, Block A 1, Nauroji Nagar, Safdarjung Enclave
New Delhi
DELHI
110029
India |
| Phone |
9686354389 |
| Fax |
|
| Email |
drabhinav1975@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhijit B R |
| Designation |
Senior Resident |
| Affiliation |
JPNATC, AIIMS, New Delhi |
| Address |
Division Of Trauma Surgery And Critical Care,
Department Of Surgical Disciplines,
Jai Prakash Narayan Apex Trauma Center, AIIMS, New Delhi
A1/273, Block A 1, Nauroji Nagar, Safdarjung Enclave
Division Of Trauma Surgery And Critical Care,
Department Of Surgical Disciplines,
Jai Prakash Narayan Apex Trauma Center, AIIMS, New Delhi
A1/273, Block A 1, Nauroji Nagar, Safdarjung Enclave
New Delhi
DELHI
110029
India |
| Phone |
9686354389 |
| Fax |
|
| Email |
br.alchemist@gmail.com |
|
|
Source of Monetary or Material Support
|
| Support to be received from affiliated institution- JPNATC, AIIMS, New Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
JPNATC AIIMS New Delhi |
| Address |
JPNATC, Ring Rd, Raj Nagar, Safdarjung Enclave, New Delhi, Delhi 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Abhinav Kumar |
Additional Professor, Ring Rd, Raj Nagar, Safdarjung Enclave, New Delhi, Delhi 110029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhijit B R |
JPNATC, AIIMS, New Delhi |
Division Of Trauma Surgery And Critical Care,
Department Of Surgical Disciplines,
Jai Prakash Narayan Apex Trauma Center, AIIMS, New Delhi
A1/273, Block A 1, Nauroji Nagar, Safdarjung Enclave
New Delhi
DELHI |
9686354389
br.alchemist@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Comittee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pre-emptive Regenerative Peripheral Nerve Interface |
RPNI involves a free muscle graft (frequently vastus lateralis) that is neurotized by a transected peripheral nerve, with the muscle graft amplifying bioelectric signals and housing an electrode for signal transduction to a neuroprosthetic limb. The denervated free muscle graft undergoes revascularization and becomes a target for the regenerating axons of the transected peripheral nerve, resulting in the formation of new neuromuscular connections instead of a neuroma RPNI has been utilized for treatment of symptomatic neuroma as well as prophylactically at time of initial amputation to prevent formation of neuroma. Because free muscle grafts can be harvested from amputated tissue and there is no sacrifice of intact donor nerves, RPNI is a low morbidity option for prevention of neuroma formation that has demonstrated promising results in limited human trials.
This study will be conducted for a period of 2 years from ethical clearance. |
| Comparator Agent |
Traction Neurectomy |
The nerve is placed under gentle traction, transected proximally, and buried within local soft tissue or muscle, as per standard surgical practice. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients undergoing transfemoral/transtibial amputation
2. Hemodynamically stable patients
3. Patients between the ages of 18-65 years
|
|
| ExclusionCriteria |
| Details |
1. Patients who do not consent to the study
2. Proximal injury to the sciatic nerve, quadriplegia and paraplegia
3. Patients with severe or moderate head injury, unable to follow directions and comply with treatment
4. Patients who need ventilator support for more than 48-72 hours
5. Pregnant females
6. Known psychiatry illness
Post randomisation exclusion
• Patient who requires stump revision or debridement after RPNI will be excluded
• Death of patients, if any.
• Intensive Care Unit (ICU) stay of more than 48-72 hours
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| residual limb pain(RLP) by using the Numerical Rating Scale(NRS) pain score between the RPNI group(Intervention group) and the conventional(Traction Neurectomy) group in patients undergoing transfemoral/transtibial amputation is lesser in RPNI when compared to traction neurectomy group |
1 week, 1 month and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Phantom limb pain(PLP) and Incidence of neuroma are both lesser in RPNI group |
1 week, 1 month and 3 months |
| Comparison of Numerical Rating scale, PainDETECT, PROMIS-P and HADS score between RPNI and traction neurectomy groups |
1 week, 1 month and 3 months |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/03/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is required to address the ongoing challenge of chronic post-amputation pain, which significantly impairs rehabilitation and quality of life in patients undergoing lower limb amputation following trauma. Traditional traction neurectomy often fails to prevent neuroma formation and neuropathic pain. The Regenerative Peripheral Nerve Interface (RPNI) technique has shown promise in promoting physiologic nerve healing and reducing pain, but robust comparative data in post-traumatic cases are lacking. By comparing pain outcomes between pre-emptive RPNI and traction neurectomy through a randomized controlled trial, this study aims to provide evidence-based guidance to improve surgical outcomes in trauma care. |