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Clinical Trials/NCT06237270
NCT06237270CompletedNot Applicable

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

Siriraj Hospital1 site in 1 country200 target enrollmentStarted: March 18, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
200
Locations
1
Primary Endpoint
Number of participants with failure of biceps recovery at 24 months

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
10 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Panai Laohaprasitiporn, MD

Principal Investigator

Siriraj Hospital

Study Sites (1)

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