NCT06313658

Brief Summary

Interpreting the published outcomes of hand function in total BPBI is confounded by a lack of clear documentation regarding detailed surgical findings and management strategies. Investigators have followed a well-defined protocol for surgical reconstruction with the primary objective being reinnervation of the lower trunk using the best available root. In this paper, Investigators outline the details of the strategy and provide a comprehensive analysis of the nerve reconstruction techniques and the resulting functional outcomes.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

March 2, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

March 15, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

1 year

First QC Date

March 2, 2024

Last Update Submit

March 10, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Active Movement Scale (AMS)

    All patients included in the study were evaluated using the Active Movement Scale (AMS), which grades upper extremity movements from 0 to 7. Scores of 6 or 7 would be considered successful in demonstrating functionally useful movement; this is a 50% and full range of movement against gravity, respectively.Attention was focused on sex movements primarily involving hand function including wrist, finger, and thumb flexion and extension.

    1 year

Secondary Outcomes (2)

  • Al-Qattan pronation/Supination score

    1 year

  • Raimondi hand score

    1 year

Interventions

In the adopted strategy, anatomical reconstruction was always performed when feasible and the lower trunk was considered the primary reinnervation target. Anatomical reconstruction of the plexus was attempted in the presence of at least three available roots; the best quality root stump (usually C5) was used for hand reanimation, while the lower ruptured roots were directed towards the upper and middle trunks. If one or more of the remaining root stumps were of doubtful quality, the compromised roots were grafted to the posterior divisions of the upper and middle trunks, while elbow flexion could be restored by transferring the intercostal nerves (T3-5) to the lateral cord. The lateral root of the median nerve was also included in the intercostal nerve transfer to restore hand sensations. In all cases, the spinal accessory nerve was directly sutured to the suprascapular nerve to restore rotator cuff function.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will include at least 50 children: Who underwent brachial plexus exploration and reconstruction for total OBPP. who have reached at least four years of follow-up Excluding children who had selective distal neurotization for restoration of specific functions without brachial plexus exploration or who had secondary procedures to the hand.

You may qualify if:

  • Patients Who underwent brachial plexus exploration and reconstruction for total OBPP.
  • who have reached at least four years of follow-up

You may not qualify if:

  • Excluding children who had selective distal neurotization for restoration of specific functions without brachial plexus exploration or who had secondary procedures to the hand.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospitals

Asyut, 71526, Egypt

RECRUITING

Related Publications (4)

  • Haerle M, Gilbert A. Management of complete obstetric brachial plexus lesions. J Pediatr Orthop. 2004 Mar-Apr;24(2):194-200. doi: 10.1097/00004694-200403000-00012.

    PMID: 15076607BACKGROUND
  • Al-Qattan MM. Assessment of the motor power in older children with obstetric brachial plexus palsy. J Hand Surg Br. 2003 Feb;28(1):46-9. doi: 10.1054/jhsb.2002.0831.

    PMID: 12531668BACKGROUND
  • Borschel GH, Clarke HM. Obstetrical brachial plexus palsy. Plast Reconstr Surg. 2009 Jul;124(1 Suppl):144e-155e. doi: 10.1097/PRS.0b013e3181a80798.

    PMID: 19568147BACKGROUND
  • Pondaag W, Malessy MJ. Recovery of hand function following nerve grafting and transfer in obstetric brachial plexus lesions. J Neurosurg. 2006 Jul;105(1 Suppl):33-40. doi: 10.3171/ped.2006.105.1.33.

    PMID: 16871868BACKGROUND

MeSH Terms

Interventions

Plastic Surgery Procedures

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Central Study Contacts

Yousif ElGammal

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

March 2, 2024

First Posted

March 15, 2024

Study Start

March 15, 2024

Primary Completion

March 15, 2025

Study Completion

March 15, 2025

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations