Reanimation of Shoulder External Rotation Via Neurotization

NCT ID: NCT06787391

Last Updated: 2025-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-20

Study Completion Date

2026-10-01

Brief Summary

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

Detailed Description

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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)

Conditions

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Nerve Transfer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Measurement of clinical outcome of Reanimation Of Shoulder External Rotation In Children With Obestetric Brachial Plexus Palsy Through Neurotization Of Spinal Accessory Nerve To Supra- Scapular Nerve.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Just one group of patients children with OBPP presented with deficiency of active shoulder External

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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

Intervention Type PROCEDURE

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

Interventions

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

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

Intervention Type PROCEDURE

Neurotization of Spinal Accessory Nerve To Supra-Scapular Nerve

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Faraag Abu el wafa Sayed

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Omar Ahmed Refai Mohammed, Assistant professor

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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Ahmed Faraag Abu el wafa Sayed, Primary investigator

Role: CONTACT

+0201123828697

Amr El sayed Ali Ibrahim, Professor

Role: CONTACT

+0201099021770

References

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Elzinga KE, Curran MW, Morhart MJ, Chan KM, Olson JL. Open Anterior Release of the Superior Transverse Scapular Ligament for Decompression of the Suprascapular Nerve During Brachial Plexus Surgery. J Hand Surg Am. 2016 Jul;41(7):e211-5. doi: 10.1016/j.jhsa.2016.03.005. Epub 2016 Apr 22.

Reference Type BACKGROUND
PMID: 27113908 (View on PubMed)

Pondaag W, Malessy MJ, van Dijk JG, Thomeer RT. Natural history of obstetric brachial plexus palsy: a systematic review. Dev Med Child Neurol. 2004 Feb;46(2):138-44. doi: 10.1017/s0012162204000258. No abstract available.

Reference Type BACKGROUND
PMID: 14974639 (View on PubMed)

Gilbert A. Indications and strategy. In: Gilbert A, editor. Brachial plexus injuries. London: Martin Dunitz; 2001. p. 205-10.

Reference Type BACKGROUND

Dailiana ZH, Mehdian H, Gilbert A. Surgical anatomy of spinal accessory nerve: is trapezius functional deficit inevitable after division of the nerve? J Hand Surg Br. 2001 Apr;26(2):137-41. doi: 10.1054/jhsb.2000.0487.

Reference Type BACKGROUND
PMID: 11281665 (View on PubMed)

Upton AR, McComas AJ. The double crush in nerve entrapment syndromes. Lancet. 1973 Aug 18;2(7825):359-62. doi: 10.1016/s0140-6736(73)93196-6. No abstract available.

Reference Type BACKGROUND
PMID: 4124532 (View on PubMed)

Leechavengvongs S, Malungpaishorpe K, Uerpairojkit C, Ng CY, Witoonchart K. Nerve Transfers to Restore Shoulder Function. Hand Clin. 2016 May;32(2):153-64. doi: 10.1016/j.hcl.2015.12.004.

Reference Type BACKGROUND
PMID: 27094888 (View on PubMed)

Bhandari PS, Sadhotra LP, Bhargava P, Bath AS, Mukherjee MK, Bhatti T, Maurya S. Surgical outcomes following nerve transfers in upper brachial plexus injuries. Indian J Plast Surg. 2009 Jul;42(2):150-60. doi: 10.4103/0970-0358.59272.

Reference Type BACKGROUND
PMID: 20368849 (View on PubMed)

Narakas AO, Hentz VR. Neurotization in brachial plexus injuries. Indication and results. Clin Orthop Relat Res. 1988 Dec;(237):43-56.

Reference Type BACKGROUND
PMID: 3056647 (View on PubMed)

Waters PM, Smith GR, Jaramillo D. Glenohumeral deformity secondary to brachial plexus birth palsy. J Bone Joint Surg Am. 1998 May;80(5):668-77. doi: 10.2106/00004623-199805000-00007.

Reference Type BACKGROUND
PMID: 9611027 (View on PubMed)

Buterbaugh KL, Shah AS. The natural history and management of brachial plexus birth palsy. Curr Rev Musculoskelet Med. 2016 Dec;9(4):418-426. doi: 10.1007/s12178-016-9374-3.

Reference Type BACKGROUND
PMID: 27680748 (View on PubMed)

Terzis JK, Papakonstantinou KC. Management of obstetric brachial plexus palsy. Hand Clin. 1999 Nov;15(4):717-36.

Reference Type BACKGROUND
PMID: 10563272 (View on PubMed)

Foad SL, Mehlman CT, Ying J. The epidemiology of neonatal brachial plexus palsy in the United States. J Bone Joint Surg Am. 2008 Jun;90(6):1258-64. doi: 10.2106/JBJS.G.00853.

Reference Type BACKGROUND
PMID: 18519319 (View on PubMed)

Related Links

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Other Identifiers

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Neurotization in OBPP

Identifier Type: -

Identifier Source: org_study_id

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