Surgical Treatment of Fractures of the Dorso-lombar Spine

Spine Fracture Clinical Trial

Official title:

Surgical Treatment of Fractures of the Dorso-lombar Spine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06374472
• Other study ID #: IRB00001194
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: January 1, 2022

Study information

• Verified date: April 2024
• Source: Ibn Jazzar Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

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 rarely the vital prognosis . The thoracolumbar spine has an extended transition zone between the tenth thoracic vertebra (T10) and the second lumbar vertebra (L2): the thoracolumbar hinge which, given its particular anatomical situation between a poorly mobile thoracic segment and a dynamic lumbar segment, is the predilection for occurrence of fractures and dislocations . 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. The analysis of the lesion mechanism and its consequences depends on the understanding of the classification of these lesions which are essential for therapeutic conduct . Surgical treatment constitutes a key element in the management strategy for these fractures

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Fractures, Bone
• Spinal Fractures
• Spine Fracture

Intervention

Procedure:
• Osteosynthesis
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.

Locations

Country	Name	City	State
Tunisia	IBN jazzar hospital	Kairouan

Sponsors (1)

Lead Sponsor	Collaborator
Ibn Jazzar Hospital

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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