NCT05315375

Post-trauma Lumbar Vertebral Body Reconstruction Using Expandable Cages

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 27 (actual)
• Sponsor: Centre de l'arthrose, Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Disc Degeneration

Interventions

Type	Name	Description
DEVICE	corpectomy	vertebral corpectomy using expandable cage

Timeline

• Start date: 2010-01-02
• Primary completion: 2017-12-31
• Completion: 2022-03-30
• First posted: 2022-04-07
• Last updated: 2022-04-07

Regulatory

• FDA-regulated device study