FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/093053 [Registered on: 14/08/2025] Trial Registered Prospectively
Last Modified On: 13/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing two shoulder muscle transfer techniques for nerve injury recovery  
Scientific Title of Study   Functional outcome following conventional vs modified trapezius transfer with TFL graft in post traumatic brachial plexus injury – a randomized controlled clinical 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  Shikha Shukla 
Designation  Senior Resident 
Affiliation  AIIMS, New Delhi 
Address  Department of Plastic, Reconstructive and Burns Surgery All India Institute of Medical Sciences New Delhi

New Delhi
DELHI
110029
India 
Phone  7727840669  
Fax    
Email  enchantressshikha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Raj Kumar Manas 
Designation  Additional Professor 
Affiliation  AIIMS 
Address  Department of Plastic, Reconstructive and Burns Surgery All India Institute of Medical Sciences New Delhi

New Delhi
DELHI
110029
India 
Phone  9643735358  
Fax    
Email  rajmanas007@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Shikha Shukla 
Designation  Senior Resident 
Affiliation  AIIMS, New Delhi 
Address  Department of Plastic, Reconstructive and Burns Surgery All India Institute of Medical Sciences New Delhi


DELHI
110029
India 
Phone  7727840669  
Fax    
Email  enchantressshikha@gmail.com  
 
Source of Monetary or Material Support  
Department of Plastic, Reconstructive and Burns Surgery, All India Institute of Medical Sciences, New Delhi 
 
Primary Sponsor  
Name  Shikha Shukla 
Address  Senior Resident Department of Plastic, Reconstructive and Burns Surgery All India Institute of Medical Sciences New Delhi  
Type of Sponsor  Other [Self] 
 
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 Shikha Shukla  AIIMS, New Delhi  Department of Plastic, Reconstructive and Burns Surgery All India Institute of Medical Sciences New Delhi
New Delhi
DELHI 
7727840669

enchantressshikha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Trapezius Transfer  Group A – Conventional Trapezius Transfer Standard surgical technique of trapezius muscle transfer without the use of any graft for the same indication. results will be measured after 6 weeks, 3 months and 6 months. 
Intervention  Modified Trapezius Transfer with Tensor Fascia Lata (TFL) Graft  Group B – Modified Trapezius Transfer with Tensor Fascia Lata (TFL) Graft Surgical transfer of the trapezius muscle augmented with an autologous TFL graft to reinforce shoulder abduction and stability in patients with post-traumatic brachial plexus injury.a TFL graft will be taken from the thigh and used to augment the trapezius muscle which will be further fixed to deltoid and periosteum of humerus. results will be measured after 6 weeks, 3 months and 6 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients aged 18–60 years with post-traumatic BPI affecting shoulder function.
2. Preserved trapezius muscle function (MRC Grade more than or equal to 4.
3. Willing to consent and participate in follow-up assessment
s. 
 
ExclusionCriteria 
Details  1. Prior surgery involving the shoulder girdle apart from the index procedure.
2. Neuromuscular disorders affecting the upper limb.
3. Any associated fracture around shoulder joint that reduces the passive range of movement
4. Graft site infection or comorbidities precluding surgery.
5. Birth brachial plexus injury patients. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the improvement in active shoulder abduction between patients undergoing conventional trapezius transfer and those undergoing modified trapezius transfer using tensor fascia lata graft   Regular follow up after surgery is needed at 6 weeks ,3 and 6 months for measuring functional outcome which will be recorded in the performa. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate muscle strength (MRC grading) of the shoulder
abductors (transferred trapezius) in both groups.
2. To assess & compare pain levels using the Visual Analog Scale (VAS) pre operatively & postoperatively at follow-up intervals.
3. To analyze patient-reported satisfaction & subjective functional outcomes using a structured feedback form.
4. To document & compare the intraoperative & postoperative complications in both surgical techniques.
5. To compare the rehabilitation timeline, cost effectiveness & ease of recovery between the two procedures.
6. To evaluate graft related morbidity (in the modified group) 
Regular follow up after surgery is needed at 6 weeks ,3 & 6 months for measuring functional outcome which will be recorded in the performa. 
   
 
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 2 
Date of First Enrollment (India)   24/08/2025 
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  

Traumatic brachial plexus injuries (BPI) are among the most challenging conditions in reconstructive surgery, particularly when shoulder function is compromised due to deltoid and supraspinatus paralysis. Restoration of shoulder abduction and external rotation plays a critical role in improving upper limb utility and patient independence. In cases where primary nerve repair fails or is not feasible, secondary muscle transfers serve as a vital salvage option. Among these, trapezius transfer has emerged as a time-tested method for restoring shoulder abduction, leveraging the preserved function of the spinal accessory nerve.

Conventional trapezius transfer (CTT), as described by multiple surgeons, often involves the transfer of a bony segment of the acromion or clavicle along with the trapezius insertion to the proximal humerus. While functionally effective, this approach necessitates extensive dissection, osteotomies, and hardware fixation, thereby increasing surgical morbidity, postoperative immobilization, and complication rates such as nonunion or infection.

Recent advancements have introduced modified techniques involving the use of tensor fascia lata (TFL) grafts to elongate the trapezius tendon and allow for a purely soft-tissue-based transfer to the deltoid insertion area. This modification, first described by Mayer, eliminates the need for bone work and may reduce operative risk, simplify the procedure, and shorten recovery time. Early reports suggest promising functional outcomes, but comprehensive, comparative evaluation of this modified technique against the conventional approach is still lacking in the literature.

Furthermore, while isolated studies have assessed surgical feasibility and immediate functional outcomes, few have incorporated patient-reported outcome measures, complication profiles, and long-term follow-up. No large-scale, direct, comparative studies have yet explored the differences in efficacy, safety, and patient satisfaction between the traditional and modified methods in a systematic, randomised manner.

Given these gaps in current knowledge and the potential benefits of the modified approach, a structured comparison is both timely and essential. This study aims to fill that void by evaluating and comparing the outcomes of conventional versus modified trapezius transfer techniques, using a randomised control trial. The findings of this study may help establish evidence-based indications for each method and guide clinical decision-making in the functional reconstruction of the shoulder in BPI.

 
Close