Clinical trial NCT06787391: Reanimation of Shoulder External Rotation Via Neurotization
Official title: Reanimation of Shoulder External Rotation in Children with Obestetric Brachial Plexus Palsy Through Neurotization of Spinal Accessory Nerve to Supra- Scapular Nerve
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nerve Transfer
Keywords: Nerve transfer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 25
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: TREATMENT

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Neurotization in OBPP
timeFrame: Baseline
Secondary outcomes:
measure: Measurement of ROM after Neurotization
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Omar Ahmed Refai Mohammed, Assistant professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: El-Gammal TA, Fathi NA. Outcomes of surgical treatment of brachial plexus injuries using nerve grafting and nerve transfers. J Reconstr Microsurg. 2002 Jan;18(1):7-15. doi: 10.1055/s-2002-19703.
citation: Gilbert A. Indications and strategy. In: Gilbert A, editor. Brachial plexus injuries. London: Martin Dunitz; 2001. p. 205-10.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Narakas AO, Hentz VR. Neurotization in brachial plexus injuries. Indication and results. Clin Orthop Relat Res. 1988 Dec;(237):43-56.
citation: 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.
citation: 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.
citation: Terzis JK, Papakonstantinou KC. Management of obstetric brachial plexus palsy. Hand Clin. 1999 Nov;15(4):717-36.
citation: 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.