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CTRI Number  CTRI/2025/07/090228 [Registered on: 04/07/2025] Trial Registered Prospectively
Last Modified On: 04/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing Two Nerve Transfer Techniques to Restore Elbow Movement After Upper Arm Nerve Injury: A Randomised Study 
Scientific Title of Study   Median Nerve Fascicle Transfer Versus Ulnar Nerve Fascicle Transfer to Biceps motor branch of Musculocutaneous nerve for Restoration of Elbow Flexion in Patients with C5 C6 C7 Brachial Plexus Root Injury: A Randomised Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shrimoyee Roy 
Designation  Academic Senior Resident 
Affiliation  All India Institute of Medical Sciences, Kalyani 
Address  Room no 224,226 Department of Burns and Plastic Surgery All India Institute of Medical Sciences, Kalyani NH 34 Connector, Basantapur, Saguna, West Bengal 741245

Nadia
WEST BENGAL
741245
India 
Phone  8910785369  
Fax    
Email  shrimoyee.prs_acsr25@aiimskalyani.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Prof. (Dr.) Gaurab Ranjan Chaudhuri 
Designation  Head of the Department 
Affiliation  All India Institute of Medical Sciences, Kalyani 
Address  All India Institute of Medical Sciences, Kalyani NH 34 Connector, Basantapur, Saguna, West Bengal 741245

Nadia
WEST BENGAL
741245
India 
Phone  9748044093  
Fax    
Email  gaurab.prs@aiimskalyani.edu.in  
 
Details of Contact Person
Public Query  
Name  Shrimoyee Roy 
Designation  Academic Senior Resident 
Affiliation  All India Institute of Medical Sciences, Kalyani 
Address  Room no. 224,226 Department of Burns and Plastic Surgery All India Institute of Medical Sciences, Kalyani NH 34 Connector, Basantapur, Saguna, West Bengal 741245


WEST BENGAL
741245
India 
Phone  8910785369  
Fax    
Email  shrimoyee.prs_acsr25@aiimskalyani.edu.in  
 
Source of Monetary or Material Support  
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, KALYANI 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Kalyani 
Address  NH 34 Connector, Saguna, Basantapur, West Bengal 741245 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shrimoyee Roy  All India Institute of Medical Sciences, Kalyani  Room no, 224,226 Department of Burns and Plastic Surgery All India Institute of Medical Sciences, Kalyani NH 34 Connector, Saguna, Basantapur, West Bengal 741245
Nadia
WEST BENGAL 		 8910785369

shrimoyee.prs_acsr25@aiimskalyani.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee All India Instituite of Medical Sciences, Kalyani   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G540||Brachial plexus disorders, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Median nerve fasicle transfer  A median nerve fascicle will be transferred to the motor branch of Biceps muscle (branch of Musculocutaneous nerve) for elbow flexion. Patients will be followed up till 6 months post op with EMG, NCV at regular intervals. 
Comparator Agent  NIL  NIL 
Intervention  Ulnar nerve fascicle transfer  Ulnar Nerve fascicle transfer to the motor branch of biceps muscle (musculocutaneous nerve) for elbow flexion. Patients will be followed up 6 months post op with NCV and EMG at regular intervals. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Diagnosed with C5, C6, C7 brachial plexus injury (confirmed via clinical, electrodiagnostic, EMG, MRI/CT studies) with intact hand function.
2.Absence of complete brachial plexus avulsion.
3.Presenting to OPD between 3 to 12 months since the time of injury.
4.Willing to follow up
 
 
ExclusionCriteria 
Details  1. Complete brachial plexus injury (C5–T1).
2.Severe comorbidities affecting nerve recovery (like diabetes, peripheral neuropathy).
3. Previous trauma affecting the donor nerves.
4. Elbow joint arthrodesis
5. Displaced/ un displaced fracture of the said upper limb
6. Prior nerve transfer surgery for elbow flexion.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
elbow flexion strength and
recovery of biceps muscle strength  		 at 2,4,6 months post operative 
 
Secondary Outcome  
Outcome  TimePoints 
Rate of nerve growth at 2, 4 & 6th month with NCV study
Electromyographic evidence of reinnervation at 2, 4 & 6th month
Donor site morbidity (e.g., sensory or motor deficits in the hand).

 		 at 2, 4, 6 months post surgery. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Phase 3 
Date of First Enrollment (India)   01/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
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 Applicable 
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   Restoring elbow flexion is the primary goal in treating upper brachial plexus injury, especially when there is a damage to the C5,C6 roots with C7 compromise which results in a loss of brachialis and biceps function. Our study aims to compare median nerve fascicle vs ulnar nerve fascicle transfer to the motor branch of Biceps ( branch of Musculocutaneous nerve) in patients with fair hand function in whom double nerve transfer is not possible to optimize a surgical strategy for such patients.  
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