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OpenTrials
Completed

NCT Number: NCT07192250

Thoracolumbar Burst Fracture Management: Randomized Trial

Between December 2019 to December 2022, patients presenting to causalty department with TL fracture type A3 and A4 with a TL AOSIS scores of 4 and 5 were randomly managed either by conservative or operative management.

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Key information

Conditions

Evaluation of the Validity of Thoracolumbar AO Spine Injury Score (TL AOSIS) in A3 and A4 Fractures

Age range

21 year–57 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sohag University Hospital

Sohag, Sohag Governorate, 82425, Egypt

About this study

Conservative management group was treated by bed rest and brace for 3 weeks followed by early mobilization. Operative management group received management through Short-segment fixation with one or two screws in fractured vertebra when applicable with posterior spinal fusion. Patients were evaluated both clinically regarding pain (VAS score), disability by Oswestry Disability Index (ODI score) and neurological status. Radiological evaluation included local sagittal spinal alignment, including pre- and post- management Cobb angle and local segment kyphosis. Bony fusion was also evaluated.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Skeletally mature patients (age 21-55 years old), TL spine fractures of types A3 and A4 with TL AOSIS score 4 or 5. These include different variables; A4N0, A3N1, A3N2 and A3M1N0.

Exclusion criteria

  • Osteoporotic fractures and skeletally immature patients, associated comorbidities (e.g. bleeding disorders, rheumatoid arthritis), or any fracture type other than A3 and A4, and significant neurological compromise.

Treatment and study plan

short segment TPF

Procedure

short segment transpedicular screw fixation with one or two screws in fractured vertebra

conservative management

Procedure

brace and bed rest with mobilization as tolerated

Primary outcomes

  1. Pain score

    Time frame: 6 months

    VAS score

  2. healing

    Time frame: 6 months

    radiological union

  3. deformity

    Time frame: 1 year

    Cobb angle

Secondary outcomes

  1. function

    Time frame: 1 year

    ODI score

Sponsors and collaborators

Lead sponsor

Ahmed Hamed Kassem Abdelaal

Other

Registry information

Official study title

The Thoracolumbar AOSpine Injury Score: Clinical And Radiological Outcomes Of Management Of Fractures Having Scores Of 4 And 5: A Prospective Randomized Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Sep 25, 2025
Registry last updated
Sep 25, 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.