Thoracolumbar Burst Fracture Management: Randomized Trial

N/ACompletedNCT07192250

Ahmed Hamed Kassem Abdelaal80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

short segment TPFPROCEDURE

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

conservative managementPROCEDURE

brace and bed rest with mobilization as tolerated

Eligibility

Sex: ALLMin age: 21 YearsMax age: 57 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sohag University Hospital

Sohag, Sohag Governorate, Egypt

Outcomes

Primary Outcomes

Pain score

VAS score

Time frame: 6 months

healing

radiological union

Time frame: 6 months

deformity

Cobb angle

Time frame: 1 year

Secondary Outcomes

function

ODI score

Time frame: 1 year

Data from ClinicalTrials.gov

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