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Short Segment vs Long Segment Fixation in Traumatic Dorsolumbar Spine Fractures

Primary Purpose

SPINAL Fracture

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

short segment posterior spine fixation

long segment posterior spine fixation

About this trial

This is an interventional treatment trial for SPINAL Fracture focused on measuring thoracolumbar fracture, short segment fixation, long segment fixation, index level

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Short Segment posterior spine fixation

Long Segment posterior spine fixation

Arm Description

Short segment transpedicular screw fixation with inclusion of the index level

Long segment transpedicular screw fixation with escape of the index level

Outcomes

Primary Outcome Measures

Change in pain

Visual analogue scale assessment

Change in disability

assessment of Oswestry Disability Scale

Change in angle of correction

Measurement of Cobb's angle

Secondary Outcome Measures

Full Information

NCT ID

NCT03272243

First Posted

August 31, 2017

Last Updated

September 1, 2017

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT03272243

Brief Title

Short Segment vs Long Segment Fixation in Traumatic Dorsolumbar Spine Fractures

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

February 1, 2012 (Actual)

Primary Completion Date

February 28, 2016 (Actual)

Study Completion Date

November 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

SPINAL Fracture

Keywords

thoracolumbar fracture, short segment fixation, long segment fixation, index level

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

91 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Short Segment posterior spine fixation

Arm Type

Active Comparator

Arm Description

Short segment transpedicular screw fixation with inclusion of the index level

Arm Title

Long Segment posterior spine fixation

Arm Type

Active Comparator

Arm Description

Long segment transpedicular screw fixation with escape of the index level

Intervention Type

Procedure

Intervention Name(s)

short segment posterior spine fixation

Intervention Type

Procedure

Intervention Name(s)

long segment posterior spine fixation

Primary Outcome Measure Information:

Title

Change in pain

Description

Visual analogue scale assessment

Time Frame

3rd, 6th, 9th, 12th months

Title

Change in disability

Description

assessment of Oswestry Disability Scale

Time Frame

3rd, 6th, 9th, 12th months

Title

Change in angle of correction

Description

Measurement of Cobb's angle

Time Frame

3rd, 6th, 9th, 12th months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Walid A Abdel Ghany, M.D., Ph.D

Organizational Affiliation

Associate Professor of Neurosurgery

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

Short Segment vs Long Segment Fixation in Traumatic Dorsolumbar Spine Fractures

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