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OpenTrials
Completed

NCT Number: NCT06237270

A Multicenter External Validation of a Novel Prediction Model for Elbow Flexion Recovery After Nerve Transfer Surgery in Brachial Plexus Injuries

The goal of this observational study is to validate a risk prediction model developed for unsuccessful elbow flexion recovery after nerve transfer surgery in patients with brachial plexus injury. The main question it aims to answer is how well a risk prediction model perform in a different dataset, which are patients with brachial plexus injury who underwent surgery in a different time period or a different hospital.

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Key information

Age range

10 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Traumatic brachial plexus injury patients underwent nerve transfer operation for re-innervation of elbow flexion at Siriraj Hospital between 2018 and 2020 and Lerdsin General Hospital between 2008 and 2022
  • Patients had follow-up duration at least 24 months after surgery

Exclusion criteria

  • Incomplete medical records
  • Patients underwent free functioning muscle transfer as primary surgery for elbow flexion
  • Obstetric brachial plexus injury
  • Radiation-induced brachial plexopathy

Treatment and study plan

Nerve transfer surgery for elbow flexion

Procedure

A functioning but less important nerve (e.g. spinal accessory nerve, phrenic nerve, fascicle of median nerve, or fascicle of ulnar nerve) was transferred to nerves innervating biceps or brachialis muscle to restore elbow flexion.

Primary outcomes

  1. Number of participants with failure of biceps recovery at 24 months

    Time frame: 24 months

    Medical research council motor grading system of less than 3 at 24 months after surgery

Sponsors and collaborators

Lead sponsor

Siriraj Hospital

Other

Collaborators

  • Lerdsin General Hospital

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 1, 2024
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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