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临床试验/CTRI/2025/08/093053
CTRI/2025/08/093053尚未招募2 期

Functional outcome following conventional vs modified trapezius transfer with TFL graft in post traumatic brachial plexus injury – a randomized controlled clinical trial

Shikha Shukla1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年8月24日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
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

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 18–60 years with post-traumatic BPI affecting shoulder function.
  • Preserved trapezius muscle function (MRC Grade more than or equal to
  • Willing to consent and participate in follow-up assessment s.

排除标准

  • Prior surgery involving the shoulder girdle apart from the index procedure.
  • Neuromuscular disorders affecting the upper limb.
  • Any associated fracture around shoulder joint that reduces the passive range of movement
  • Graft site infection or comorbidities precluding surgery.
  • Birth brachial plexus injury patients.

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 1. To evaluate muscle strength (MRC grading) of the shoulder(abductors (transferred trapezius) in both groups.)

研究者

发起方
Shikha Shukla
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Shikha Shukla

AIIMS, New Delhi

研究点 (1)

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