Reanimation of Shoulder External Rotation Via Neurotization
1 other identifier
interventional
25
0 countries
N/A
Brief Summary
Measurement of clinical outcome after nerve transfer in deficiency of shoulder external rotation in children with OBPP.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2025
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2025
CompletedStudy Start
First participant enrolled
January 20, 2025
CompletedFirst Posted
Study publicly available on registry
January 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
January 22, 2025
January 1, 2025
1.5 years
January 14, 2025
January 21, 2025
Conditions
Keywords
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 COMPARATORInterventions
Neurotization of Spinal Accessory Nerve To Supra-Scapular Nerve in children with OBPP presented with deficiency of Shoulder External Rotation.
Just to assess clinical outcomes after Neurotization of spinal accessory nerve to Supra-Scapular Nerve in patients with deficiency of Shoulder External Rotation
Eligibility Criteria
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: 27113908BACKGROUNDPondaag 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: 14974639BACKGROUNDGilbert A. Indications and strategy. In: Gilbert A, editor. Brachial plexus injuries. London: Martin Dunitz; 2001. p. 205-10.
BACKGROUNDDailiana 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: 11281665BACKGROUNDUpton 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: 4124532BACKGROUNDLeechavengvongs 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: 27094888BACKGROUNDBhandari 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: 20368849BACKGROUNDNarakas AO, Hentz VR. Neurotization in brachial plexus injuries. Indication and results. Clin Orthop Relat Res. 1988 Dec;(237):43-56.
PMID: 3056647BACKGROUNDWaters 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: 9611027BACKGROUNDButerbaugh 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: 27680748BACKGROUNDTerzis JK, Papakonstantinou KC. Management of obstetric brachial plexus palsy. Hand Clin. 1999 Nov;15(4):717-36.
PMID: 10563272BACKGROUNDFoad 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
- STUDY DIRECTOR
Omar Ahmed Refai Mohammed, Assistant professor
Assiut University
Central Study Contacts
Ahmed Faraag Abu el wafa Sayed, Primary investigator
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- 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