Post-trauma Lumbar Vertebral Body Reconstruction Using Expandable Cages

Disc Degeneration Clinical Trial

Official title:

Post-trauma Lumbar Vertebral Body Reconstruction Using Expandable Cages: Comprehensive Long-term Follow-up Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05315375
• Other study ID #: vlift
• Status: Completed
• Start date: January 2, 2010
• Est. completion date: March 30, 2022

Study information

• Verified date: March 2022
• Source: Centre de l'arthrose, Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

INTRODUCTION

The expandable cage technology is not new, but several questions remain under-studied. Among them, there are the sagittal balance, the subsidence and the adjacent disc degeneration. Moreover, assessment of the correction and kyphosis regardless of the physiological angles can possibly lead to calculation bias.

The objective of this study was to assess the extent to which the functional outcomes were correlated to the quality of the reduction, within a homogeneous series of lumbar vertebral body reconstruction with expandable cages for trauma.

MATERIAL AND METHODS Twenty-seven patients with a mean follow-up of 3.9 years were retrospectively analyzed. The Oswestry Disability Index (ODI) was the main outcome and its association with other variables was sought. The local kyphosis and the regional traumatic angle using Stagnara's physiological angles were measured. The lumbar lordosis (LL) was compared to the Pelvic Incidence (PI). The subsidence of the cage and the adjacent disc degeneration (using the UCLA grading score) were quantified. Bone quality was assessed through the Hounsfield Unit of the vertebral body.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 30, 2022
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients suffered from a traumatic lumbar fracture requiring a posterior fusion first

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Disc Degeneration
• Intervertebral Disc Degeneration

Intervention

Device:
• corpectomy
vertebral corpectomy using expandable cage

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre de l'arthrose, Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry Disability Index (ODI)	specific lumbar surgery score	4 years