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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03272243
Other study ID # G10800
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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