Short Segment vs Long Segment Fixation in Traumatic Dorsolumbar Spine Fractures

Not Applicable

Completed

• Conditions: SPINAL Fracture
• Interventions: Procedure: long segment posterior spine fixation; Procedure: short segment posterior spine fixation

• Registration Number: NCT03272243
• Lead Sponsor: Ain Shams University

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-01
• Primary Completion: 2016-02-28
• Study Completion: 2016-11-30
• Study First Submitted: 2017-08-31
• Study First Submitted QC: 2017-08-31
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-01
• Study First Posted: 2017-09-05
• Last Update Posted: 2017-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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 >25⁰
• patients who needed 360⁰ fixation with long segment fixation to maintain the angle of correction.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Long Segment posterior spine fixation	long segment posterior spine fixation	Long segment transpedicular screw fixation with escape of the index level
Short Segment posterior spine fixation	short segment posterior spine fixation	Short segment transpedicular screw fixation with inclusion of the index level

Primary Outcome Measures

Name	Time	Method
Change in angle of correction	3rd, 6th, 9th, 12th months	Measurement of Cobb's angle
Change in pain	3rd, 6th, 9th, 12th months	Visual analogue scale assessment
Change in disability	3rd, 6th, 9th, 12th months	assessment of Oswestry Disability Scale