Post-trauma Lumbar Vertebral Body Reconstruction Using Expandable Cages

NCT ID: NCT05315375

Last Updated: 2022-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-02

Study Completion Date

2022-03-30

Brief Summary

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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.

Detailed Description

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Conditions

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Disc Degeneration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Corpectomy

surgical procedure using expandable cage

corpectomy

Intervention Type DEVICE

vertebral corpectomy using expandable cage

Interventions

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corpectomy

vertebral corpectomy using expandable cage

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre de l'arthrose, Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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cedric maillot

Role: STUDY_DIRECTOR

APHP

Other Identifiers

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vlift

Identifier Type: -

Identifier Source: org_study_id

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