NCT06374472

Brief Summary

Trauma to the thoracolumbar spine is responsible for potentially serious lesions, most often involving the functional prognosis in the short, medium and long term, and rare The frequency of these traumas is explained by falls from high places, especially during work accidents or suicide attempts, but also by the perpetual increase in accidents on public roads ly the vital prognosis

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 all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 15, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2024

Completed
Last Updated

April 18, 2024

Status Verified

April 1, 2024

Enrollment Period

4 years

First QC Date

April 15, 2024

Last Update Submit

April 16, 2024

Conditions

Keywords

FracturesSpineSurgeryTreatmentEvaluationResults

Outcome Measures

Primary Outcomes (3)

  • Age (in years)

    average age of our patients was 38.25 years with extremes of 16 years and 68 years

    from enrollment to the end of treatment at 4 years

  • Sex

    Our series is characterized by a significant male predominance, it included 47 men (58.75%) and 33 women (41.25%), with a sex ratio of 1.42

    from enrollment to the end of treatment at 4 years

  • Neurological status ( Frenkel classification)

    3 Frankel A patients, 1 Frankel B patient, 6 Frankel C patients and 6 Frankel D

    from enrollment to the end of treatment at 4 years

Study Arms (1)

80 cases of thoracolumbar spine fractures

Procedure: Osteosynthesis

Interventions

Some patients had osteosynthesis using a long construct, others had osteosynthesis using a short construct. Short constructs designated constructs only taking one level above and one level below the injury level (the fractured vertebra was not always included in the construct). The montages taking more than one level above or below the lesion were considered to be a long montage. Osteosynthesis is carried out using Cotrel Dubousset type rods and screws.

Also known as: Release gestures, Arthrodesis, First approach
80 cases of thoracolumbar spine fractures

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

80 cases of surgically treated thoracolumbar spine fractures

You may qualify if:

  • the files of patients hospitalized for a recent fracture of the thoracolumbar spine within 12 months

You may not qualify if:

  • Files with insufficient follow-up, patients lost to follow-up. patients presenting: A pathological fracture. Osteoporotic collapse. Material and Methods 3 Staged trauma to the spine. A fracture due to ankylosing spondylitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IBN jazzar hospital

Kairouan, 3190, Tunisia

Location

MeSH Terms

Conditions

Spinal FracturesFractures, Bone

Interventions

Fracture Fixation, InternalArthrodesis

Condition Hierarchy (Ancestors)

Spinal InjuriesBack InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 15, 2024

First Posted

April 18, 2024

Study Start

January 1, 2018

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

April 18, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

further use of this informations for others group works

Locations