NCT06458309

Brief Summary

Each year, there are approximately 5 million new vertebral fractures worldwide1. Most of these fractures involve the thoracolumbar or lumbar spines. The thoracolumbar junction, due to its mechanical transition zone, and the lumbar spine, due to its absence of stabilizing articulations with the ribs, lordotic posture and more sagittal oriented facet joints, are vulnerable for involvement in spinal injuries2. Burst fractures occurs frequently in high-energy traumas which are most commonly associated with falls and traffic accidents.3

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

May 15, 2024

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2025

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

1 year

First QC Date

June 9, 2024

Last Update Submit

June 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • AO Spine Injury Score

    * injury morphology * integrity of the PLC * neurological status

    1 year

Interventions

spine surgeryPROCEDURE

AO Classification6 It classifies thoracolumbar fractures into 3 major groups, based on the mechanism of injury.and each of them subdivided to 3 subgroups. A. Compression B. Distraction C. multi-directional with translation Thoracolumbar AO spine injury score

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Skeletally mature patients (18yrs and older). 2-Thoracolumbar fractures.

You may not qualify if:

  • skeletally immature patients. 2-pathological fractures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university Hospital

Sohag, Egypt

RECRUITING

Related Publications (4)

  • Hu R, Mustard CA, Burns C. Epidemiology of incident spinal fracture in a complete population. Spine (Phila Pa 1976). 1996 Feb 15;21(4):492-9. doi: 10.1097/00007632-199602150-00016.

    PMID: 8658254BACKGROUND
  • Tran NT, Watson NA, Tencer AF, Ching RP, Anderson PA. Mechanism of the burst fracture in the thoracolumbar spine. The effect of loading rate. Spine (Phila Pa 1976). 1995 Sep 15;20(18):1984-8. doi: 10.1097/00007632-199509150-00004.

    PMID: 8578372BACKGROUND
  • Bohlman HH. Treatment of fractures and dislocations of the thoracic and lumbar spine. J Bone Joint Surg Am. 1985 Jan;67(1):165-9. No abstract available.

    PMID: 3881446BACKGROUND
  • McAfee PC, Yuan HA, Fredrickson BE, Lubicky JP. The value of computed tomography in thoracolumbar fractures. An analysis of one hundred consecutive cases and a new classification. J Bone Joint Surg Am. 1983 Apr;65(4):461-73.

    PMID: 6833320BACKGROUND

MeSH Terms

Conditions

Spinal Fractures

Condition Hierarchy (Ancestors)

Spinal InjuriesBack InjuriesWounds and InjuriesFractures, Bone

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident- orthopedic department-sohag hospital university

Study Record Dates

First Submitted

June 9, 2024

First Posted

June 13, 2024

Study Start

May 15, 2024

Primary Completion

May 25, 2025

Study Completion

September 25, 2025

Last Updated

June 13, 2024

Record last verified: 2024-06

Locations