Post-trauma Lumbar Vertebral Body Reconstruction Using Expandable Cages

NCT05315375 | Completed FDA Device

• 1 other identifier: vlift
• Study Type: observational
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index (ODI)

  specific lumbar surgery score

  4 years

Study Arms (1)

Corpectomy

surgical procedure using expandable cage

Device: corpectomy

Interventions

corpectomy DEVICE

vertebral corpectomy using expandable cage

Corpectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• Centre de l'arthrose, Paris: lead

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• cedric maillot

  APHP

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 7, 2022
• Study Start: January 2, 2010
• Primary Completion: December 31, 2017
• Study Completion: March 30, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share