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OpenTrials
Completed

NCT Number: NCT03272243

Short Segment vs Long Segment Fixation in Traumatic Dorsolumbar Spine Fractures

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

short segment posterior spine fixation

Procedure

long segment posterior spine fixation

Procedure

Primary outcomes

  1. Change in pain

    Time frame: 3rd, 6th, 9th, 12th months

    Visual analogue scale assessment

  2. Change in disability

    Time frame: 3rd, 6th, 9th, 12th months

    assessment of Oswestry Disability Scale

  3. Change in angle of correction

    Time frame: 3rd, 6th, 9th, 12th months

    Measurement of Cobb's angle

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Sep 5, 2017
Registry last updated
Sep 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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