NCT07192250

Brief Summary

Between December 2019 to December 2022, patients presenting to causalty department with TL fracture type A3 and A4 with a TL AOSIS scores of 4 and 5 were randomly managed either by conservative or operative management.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 23, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 25, 2025

Completed
Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

2 years

First QC Date

September 17, 2025

Last Update Submit

September 17, 2025

Conditions

Evaluation of the Validity of Thoracolumbar AO Spine Injury Score (TL AOSIS) in A3 and A4 Fractures

Outcome Measures

Primary Outcomes (3)

  • Pain score

    VAS score

    6 months

  • healing

    radiological union

    6 months

  • deformity

    Cobb angle

    1 year

Secondary Outcomes (1)

  • function

    1 year

Study Arms (2)

operative group

ACTIVE COMPARATOR
Procedure: short segment TPF

conservative group

ACTIVE COMPARATOR
Procedure: conservative management

Interventions

short segment TPFPROCEDURE

short segment transpedicular screw fixation with one or two screws in fractured vertebra

operative group
conservative managementPROCEDURE

brace and bed rest with mobilization as tolerated

conservative group

Eligibility Criteria

Age21 Years - 57 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Skeletally mature patients (age 21-55 years old), TL spine fractures of types A3 and A4 with TL AOSIS score 4 or 5. These include different variables; A4N0, A3N1, A3N2 and A3M1N0.

You may not qualify if:

  • Osteoporotic fractures and skeletally immature patients, associated comorbidities (e.g. bleeding disorders, rheumatoid arthritis), or any fracture type other than A3 and A4, and significant neurological compromise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Sohag Governorate, 82425, Egypt

Location

MeSH Terms

Interventions

Conservative Treatment

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • mohamed younis, lecturer

    Sohag University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

September 17, 2025

First Posted

September 25, 2025

Study Start

December 23, 2019

Primary Completion

December 23, 2021

Study Completion

December 31, 2022

Last Updated

September 25, 2025

Record last verified: 2025-09

Locations

EG(1)