NCT04032054

Brief Summary

Comparison of short segment mono axial and poly axial pedicle screw fixation in thoracolumbar fractures regarding the best correction of the fracture and deformity and the maintenance of the correction.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Status
unknown

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

First Submitted

Initial submission to the registry

July 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

July 26, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

July 23, 2019

Last Update Submit

July 24, 2019

Conditions

Spine Fracture

Keywords

thoracolumbar fractures

Outcome Measures

Primary Outcomes (1)

  • The sagittal cobb's angel.

    the greatest angle at a particular region of the vertebral column, when measured from the superior endplate of a superior vertebra to the inferior endplate of an inferior vertebra.

    base line

Secondary Outcomes (2)

  • Vertebral body angel

    base line

  • Anterior vertebral body height

    base line

Study Arms (2)

A

mono-axial

Device: mono-axial and poly-axial screws

B

poly-axial

Device: mono-axial and poly-axial screws

Interventions

mono-axial and poly-axial screwsDEVICE

types of pedicular screws for thoracolumbar fractures fixation

AB

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

population will include all the recruited patients with thoracolumbar spine fracture eligible for our study according to inclusion and exclusion criteria

You may qualify if:

  • Thoracolumbar fractures D4 - L3.
  • Neurologically free.
  • Age of the patients to be from 20 to 60 years.
  • Type A3 and A4 according to the AO classification.

You may not qualify if:

  • Pathological or Osteoporotic fractures.
  • Lumbar degenerative diseases.
  • Multisegement spine fractures.
  • Poly traumatized patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spinal Fractures

Condition Hierarchy (Ancestors)

Spinal InjuriesBack InjuriesWounds and InjuriesFractures, Bone

Central Study Contacts

Islam mohamed, Bachelor's Degree

CONTACT

+2001016329653islammohamed846@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

July 23, 2019

First Posted

July 25, 2019

Study Start

October 1, 2019

Primary Completion

October 1, 2020

Study Completion

October 1, 2021

Last Updated

July 26, 2019

Record last verified: 2019-07