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NCT06237270 Clinical Trial

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

Brachial Plexus Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06237270
Other study ID # 123/2566(EC1)
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 17, 2023
Est. completion date October 31, 2023

Study information
Verified date June 2024
Source Siriraj Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date October 31, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers No
Gender All
Age group 10 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Nerve transfer surgery for elbow flexion
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.

Locations
Country Name City State
Thailand Faculty of Medicine Siriraj Hospital, Mahidol University Bangkoknoi Bangkok

Sponsors (2)
Lead Sponsor Collaborator
Siriraj Hospital Lerdsin General Hospital

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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