Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-29 @ 12:28 AM
Study NCT ID:
NCT07192250
Status:
COMPLETED
Last Update Posted:
2025-09-25
First Post:
2025-09-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thoracolumbar Burst Fracture Management: Randomized Trial
Sponsor:
Ahmed Hamed Kassem Abdelaal
Organization:
Study Overview
Official Title:
The Thoracolumbar AOSpine Injury Score: Clinical And Radiological Outcomes Of Management Of Fractures Having Scores Of 4 And 5: A Prospective Randomized Trial
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: