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NCT Number: NCT06787391

Reanimation of Shoulder External Rotation Via Neurotization

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

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Key information

Conditions

Age range

1 year–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neurotization of Spinal Accessory Nerve To Supra-Scapular in children with OBPP with deficiency of Shoulder External Rotation

Procedure

Neurotization of Spinal Accessory Nerve To Supra-Scapular Nerve in children with OBPP presented with deficiency of Shoulder External Rotation.

Neurotization of Spinal Accessory Nerve To Supra-Scapular Nerve

Procedure

Just to assess clinical outcomes after Neurotization of spinal accessory nerve to Supra-Scapular Nerve in patients with deficiency of Shoulder External Rotation

Primary outcomes

  1. Neurotization in OBPP

    Time frame: 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)
    • 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)
    • no active ER , Abduction to 45° ( poor)
    • neutral ER , Abduction<90(fair)
    • weak ER , Abduction= 90°( satisfactory)
    • incomplete ER, Abduction<120°( good )
    • active ER , Abduction> 120°( excellent)

Secondary outcomes

  1. Measurement of ROM after Neurotization

    Time frame: Baseline

    Asses the recovery of shoulder stability and overall. Shoulder Range of Motion (ROM):

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Faraag Abu el wafa Sayed, Primary investigator

CONTACT

[email protected]

+0201123828697

Amr El sayed Ali Ibrahim, Professor

CONTACT

[email protected]

+0201099021770

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Reanimation Of Shoulder External Rotation In Children With Obestetric Brachial Plexus Palsy Through Neurotization Of Spinal Accessory Nerve To Supra- Scapular Nerve

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2025
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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