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OpenTrials
Completed

NCT Number: NCT05315375

Post-trauma Lumbar Vertebral Body Reconstruction Using Expandable Cages

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

corpectomy

Device

vertebral corpectomy using expandable cage

Primary outcomes

  1. Oswestry Disability Index (ODI)

    Time frame: 4 years

    specific lumbar surgery score

Sponsors and collaborators

Lead sponsor

Centre de l'arthrose, Paris

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2017
Study completion
2022
First posted
Apr 7, 2022
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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