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Thoracolumbar Burst Fracture Management: Randomized Trial

A

Ahmed Hamed Kassem Abdelaal

Status

Completed

Conditions

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

Treatments

Procedure: short segment TPF
Procedure: conservative management

Study type

Interventional

Funder types

Other

Identifiers

NCT07192250
585/9/444

Details and patient eligibility

About

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.

Full description

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.

Enrollment

80 patients

Sex

All

Ages

21 to 57 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

operative group
Active Comparator group
Treatment:
Procedure: short segment TPF
conservative group
Active Comparator group
Treatment:
Procedure: conservative management

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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