Short Segment vs Long Segment Fixation in Traumatic Dorsolumbar Spine Fractures

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

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

Study Overview

• Status: Completed
• Conditions: SPINAL Fracture
• Intervention / Treatment: Procedure: short segment posterior spine fixation; Procedure: long segment posterior spine fixation

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Short Segment posterior spine fixation; Short segment transpedicular screw fixation with inclusion of the index level	Procedure: short segment posterior spine fixation
ACTIVE_COMPARATOR: Long Segment posterior spine fixation; Long segment transpedicular screw fixation with escape of the index level	Procedure: long segment posterior spine fixation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Walid A Abdel Ghany, M.D., Ph.D, Associate Professor of Neurosurgery

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2012
• Primary Completion (ACTUAL): February 28, 2016
• Study Completion (ACTUAL): November 30, 2016

Study Registration Dates

• First Submitted: August 31, 2017
• First Submitted That Met QC Criteria: August 31, 2017
• First Posted (ACTUAL): September 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 6, 2017
• Last Update Submitted That Met QC Criteria: September 1, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: thoracolumbar fracture; short segment fixation; long segment fixation; index level
• Additional Relevant MeSH Terms: Wounds and Injuries; Spinal Injuries; Back Injuries; Fractures, Bone; Spinal Fractures
• Other Study ID Numbers: G10800

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No