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临床试验/NCT06787391
NCT06787391尚未招募不适用

Reanimation of Shoulder External Rotation in Children with Obestetric Brachial Plexus Palsy Through Neurotization of Spinal Accessory Nerve to Supra- Scapular Nerve

Assiut University0 个研究点目标入组 25 人开始时间: 2025年1月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
25
主要终点
Neurotization in OBPP

研究概览

简要总结

Measurement of clinical outcome after nerve transfer in deficiency of shoulder external rotation in children with OBPP.

详细描述

Brachial plexus birth injuries (BPBI) occur in 1-2 per 1,000 live births, often resulting from traction on the shoulder during delivery (1). Right-sided injuries are more common due to fetal positioning.(2) BPBI presentations vary, with upper trunk injuries (Erb's palsy) being most frequent, accounting for 45% of cases.(3) These injuries can impair shoulder abduction, external rotation, and arm function ,He can't flex the elbow to partially reache the hand to the mouth (the trumpet sign) .due to suprascapular nerve (SSN) damage, which is prone to stretching due to its fixed attachments.(4)

Erb's palsy affects muscles like the deltoid and biceps, supraspinatus and infraspinatus.(5) . Assessments include testing hand sensation and noting color or trophic changes. Without SSN reconstruction, secondary glenohumeral complications often arise, necessitating surgical interventions like tendon transfers, joint reductions, or osteotomies.(6)

Nerve transfer, such as spinal accessory nerve (SAN) fascicles to the SSN, has shown superior outcomes for restoring shoulder function. The SAN, a pure motor nerve, is well-suited for direct coaptation without interposition grafts.(7).

Surgical approaches include anterior and posterior methods, each with unique benefits. For instance, the anterior approach allows simultaneous brachial plexus exploration and facilitates nerve repair.(8) , while posterior approach prevents double crush phenomenon.(9)

Despite most children recovering spontaneously, 20-30% experience residual deficits (10). Techniques like tension-free SAN-to-SSN repair aim to improve outcomes. This study evaluates the efficacy of SAN transfers in restoring shoulder stability, abduction, and external rotation in BPBI patients.(11)

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Year 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children within 1.5 - 3 years .
  • No previous surgery
  • full passive ROM
  • presented with Trumpet sign

排除标准

  • age <1.5 - >3 years
  • previous surgery in the shoulder
  • Stiff shoulder.
  • total OBPP
  • traumatic BPI
  • follow up <1 year.

结局指标

主要结局

Neurotization in OBPP

时间窗: Baseline

Improvement in Shoulder External Rotation after neurotization, and Functional Outcome Scores using mallet score Measurement of the clinical outcome of Active shoulder external rotation following Spinal accessory nerve to supra scapular Nerve transfer in children with Obstetric brachial plexus palsy, , * follow up one year or more , or Recovery of active ER . * based on:- * 1-------- mallet score from 1 to 5:--- (12) 1. Flail shoulder 2. Zero degree external rotation 3. Active ER up to 20 degrees 4. Active ER over than 20 degrees 5. Normal shoulder * 2----Gilbert shoulder score :- for shoulder ROM and strength (13) 0- complete flail shoulder( none) 1. no active ER , Abduction to 45° ( poor) 2. neutral ER , Abduction\<90(fair) 3. weak ER , Abduction= 90°( satisfactory) 4. incomplete ER, Abduction\<120°( good ) 5. active ER , Abduction\> 120°( excellent)

次要结局

  • Measurement of ROM after Neurotization(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Faraag Abu el wafa Sayed

Assistant Lecturer

Assiut University

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