Short Segment vs Long Segment Fixation in Traumatic Dorsolumbar Spine Fractures

SPINAL Fracture Clinical Trial

Official title:

Short Segment Posterior Fixation With Index Level Screws Versus Long Segment Posterior Fixation for Thoracolumbar Spine Fracture: Angle of Correction and Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03272243
• Other study ID #: G10800
• Status: Completed
• Phase: N/A
• First received: August 31, 2017
• Last updated: September 1, 2017
• Start date: February 1, 2012
• Est. completion date: November 30, 2016

Study information

• Verified date: September 2017
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective study included 91 patients, who had single level thoracolumbar fracture with Cobb's angle ≤ 25⁰, underwent posterior fixation. Forty four patients underwent short segment fixation with screws into the index level, and 47 patients underwent long segment fixation with skipped index level. The angle of correction, pain, and neurological state were regularly assessed

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: November 30, 2016
• Est. primary completion date: February 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• wedge fracture or burst fracture with Thoraco-Lumbar Injury Classification and Severity (TLICS) score = 4

• Single level fracture

• Less than 50% of spinal canal compromised

• Mild kyphosis or scoliosis

• Cobb's angle = 25°

• with or without neurological deficit

Exclusion Criteria:

• patients with multiple level fractures

• patients with more than 50% spinal canal compromise

• patients who needed anterior approach to decompress the canal

• patients who have fracture dislocation and / or marked kyphosis and scoliosis with Cobb's angle >25°

• patients who needed 360° fixation with long segment fixation to maintain the angle of correction.

Related Conditions & MeSH terms

• Fractures, Bone
• SPINAL Fracture
• Spinal Fractures

Intervention

Procedure:
• short segment posterior spine fixation

• long segment posterior spine fixation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain	Visual analogue scale assessment	3rd, 6th, 9th, 12th months
Primary	Change in disability	assessment of Oswestry Disability Scale	3rd, 6th, 9th, 12th months
Primary	Change in angle of correction	Measurement of Cobb's angle	3rd, 6th, 9th, 12th months