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

NCT06237270 | Completed

• 1 other identifier: 123/2566(IRB1), LH671009
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brachial Plexus Injury

Keywords

nerve transfer; neurotization; brachial plexus injury; predictive factors; external validation; risk prediction model

Outcome Measures

Primary Outcomes (1)

• Number of participants with failure of biceps recovery at 24 months

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

  24 months

Study Arms (2)

Successful biceps recovery

Motor power more than or equal to grade 3 at 24 months after surgery

Procedure: Nerve transfer surgery for elbow flexion

Failure of biceps recovery

Motor power less than grade 3 at 24 months after surgery

Procedure: Nerve transfer surgery for elbow flexion

Interventions

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.

Failure of biceps recovery; Successful biceps recovery

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Traumatic brachial plexus injury patients underwent nerve transfer operation

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Siriraj Hospital: lead
• Lerdsin General Hospital: collaborator

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 1, 2024
• Study Start: March 18, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: June 26, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)