Reanimation of Shoulder External Rotation Via Neurotization

Not Applicable

Not yet recruiting

• Conditions: Nerve Transfer

• Registration Number: NCT06787391
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

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)

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-14
• Study Start: 2025-01-20
• Study First Submitted QC: 2025-01-21
• Last Update Submitted: 2025-01-21
• Study First Posted: 2025-01-22
• Last Update Posted: 2025-01-22
• Primary Completion: 2026-08-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Neurotization in OBPP	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)

Secondary Outcome Measures

Name	Time	Method
Measurement of ROM after Neurotization	Baseline	Asses the recovery of shoulder stability and overall. Shoulder Range of Motion (ROM):