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
1 other identifier
interventional
91
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2012
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2016
CompletedFirst Submitted
Initial submission to the registry
August 31, 2017
CompletedFirst Posted
Study publicly available on registry
September 5, 2017
CompletedSeptember 6, 2017
September 1, 2017
4.1 years
August 31, 2017
September 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
Short Segment posterior spine fixation
ACTIVE COMPARATORShort segment transpedicular screw fixation with inclusion of the index level
Long Segment posterior spine fixation
ACTIVE COMPARATORLong segment transpedicular screw fixation with escape of the index level
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Walid A Abdel Ghany, M.D., Ph.D
Associate Professor of Neurosurgery
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Fellow of functional neurosurgery division
Study Record Dates
First Submitted
August 31, 2017
First Posted
September 5, 2017
Study Start
February 1, 2012
Primary Completion
February 28, 2016
Study Completion
November 30, 2016
Last Updated
September 6, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR