External Validation Study for Risk Prediction Model for Unsuccessful Elbow Flexion Recovery After Nerve Transfer Surgery in Patients With Brachial Plexus Injury

Completed

• Conditions: Brachial Plexus Injury
• Interventions: Procedure: Nerve transfer surgery for elbow flexion

• Registration Number: NCT06237270
• Lead Sponsor: Siriraj Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-17
• Primary Completion: 2023-08-31
• Study Completion: 2023-10-31
• Study First Submitted: 2024-01-23
• Study First Submitted QC: 2024-01-23
• Study First Posted: 2024-02-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Failure of biceps recovery	Nerve transfer surgery for elbow flexion	Motor power less than grade 3 at 24 months after surgery
Successful biceps recovery	Nerve transfer surgery for elbow flexion	Motor power more than or equal to grade 3 at 24 months after surgery

Primary Outcome Measures

Name	Time	Method
Number of participants with failure of biceps recovery at 24 months	24 months	Medical research council motor grading system of less than 3 at 24 months after surgery

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkoknoi, Bangkok, Thailand