Mangement of Spine Fracture

Spine Fracture Clinical Trial

Official title:

Management of Spine Fractures According to The Thoracolumbar AO Spine Injury Score

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06458309
• Other study ID #: soh_med_24_05_04ms
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: September 25, 2025

Study information

• Verified date: June 2024
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Each year, there are approximately 5 million new vertebral fractures worldwide1. Most of these fractures involve the thoracolumbar or lumbar spines. The thoracolumbar junction, due to its mechanical transition zone, and the lumbar spine, due to its absence of stabilizing articulations with the ribs, lordotic posture and more sagittal oriented facet joints, are vulnerable for involvement in spinal injuries2.

Burst fractures occurs frequently in high-energy traumas which are most commonly associated with falls and traffic accidents.3

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 25, 2025
• Est. primary completion date: May 25, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

Inclusion Criteria:

• 1-Skeletally mature patients (18yrs and older). 2-Thoracolumbar fractures.

Exclusion Criteria:

• 1-skeletally immature patients. 2-pathological fractures.

Related Conditions & MeSH terms

• Fractures, Bone
• Spinal Fractures
• Spine Fracture

Intervention

Procedure:
• spine surgery
AO Classification6 It classifies thoracolumbar fractures into 3 major groups, based on the mechanism of injury.and each of them subdivided to 3 subgroups. A. Compression B. Distraction C. multi-directional with translation Thoracolumbar AO spine injury score

Locations

Country	Name	City	State
Egypt	Sohag university Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Bohlman HH. Treatment of fractures and dislocations of the thoracic and lumbar spine. J Bone Joint Surg Am. 1985 Jan;67(1):165-9. No abstract available. — View Citation

Hu R, Mustard CA, Burns C. Epidemiology of incident spinal fracture in a complete population. Spine (Phila Pa 1976). 1996 Feb 15;21(4):492-9. doi: 10.1097/00007632-199602150-00016. — View Citation

McAfee PC, Yuan HA, Fredrickson BE, Lubicky JP. The value of computed tomography in thoracolumbar fractures. An analysis of one hundred consecutive cases and a new classification. J Bone Joint Surg Am. 1983 Apr;65(4):461-73. — View Citation

Tran NT, Watson NA, Tencer AF, Ching RP, Anderson PA. Mechanism of the burst fracture in the thoracolumbar spine. The effect of loading rate. Spine (Phila Pa 1976). 1995 Sep 15;20(18):1984-8. doi: 10.1097/00007632-199509150-00004. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AO Spine Injury Score	injury morphology; integrity of the PLC; neurological status	1 year