| 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
|
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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 |
|
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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 |
|
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Source of Monetary or Material Support
|
| Department of Plastic, Reconstructive and Burns Surgery,
All India Institute of Medical Sciences, New Delhi |
|
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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] |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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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. |
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
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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. |
|
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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. |
| |
|
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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
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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. |