NCT06787391

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Jan 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Jan 2025Oct 2026

First Submitted

Initial submission to the registry

January 14, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

January 20, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

January 22, 2025

Status Verified

January 1, 2025

Enrollment Period

1.5 years

First QC Date

January 14, 2025

Last Update Submit

January 21, 2025

Conditions

Keywords

Nerve transfer

Outcome Measures

Primary Outcomes (1)

  • Neurotization in OBPP

    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)

    Baseline

Secondary Outcomes (1)

  • Measurement of ROM after Neurotization

    Baseline

Study Arms (1)

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

ACTIVE COMPARATOR
Procedure: Neurotization of Spinal Accessory Nerve To Supra-Scapular in children with OBPP with deficiency of Shoulder External RotationProcedure: Neurotization of Spinal Accessory Nerve To Supra-Scapular Nerve

Interventions

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

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

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

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

Eligibility Criteria

Age1 Year - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • 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.

    PMID: 27113908BACKGROUND
  • 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.

    PMID: 14974639BACKGROUND
  • Gilbert A. Indications and strategy. In: Gilbert A, editor. Brachial plexus injuries. London: Martin Dunitz; 2001. p. 205-10.

    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.

    PMID: 11281665BACKGROUND
  • 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.

    PMID: 4124532BACKGROUND
  • 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.

    PMID: 27094888BACKGROUND
  • 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.

    PMID: 20368849BACKGROUND
  • Narakas AO, Hentz VR. Neurotization in brachial plexus injuries. Indication and results. Clin Orthop Relat Res. 1988 Dec;(237):43-56.

    PMID: 3056647BACKGROUND
  • 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.

    PMID: 9611027BACKGROUND
  • 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.

    PMID: 27680748BACKGROUND
  • Terzis JK, Papakonstantinou KC. Management of obstetric brachial plexus palsy. Hand Clin. 1999 Nov;15(4):717-36.

    PMID: 10563272BACKGROUND
  • 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.

    PMID: 18519319BACKGROUND

Related Links

Study Officials

  • Omar Ahmed Refai Mohammed, Assistant professor

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Ahmed Faraag Abu el wafa Sayed, Primary investigator

CONTACT

Amr El sayed Ali Ibrahim, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

January 14, 2025

First Posted

January 22, 2025

Study Start

January 20, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

January 22, 2025

Record last verified: 2025-01