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UNiD 3D VBR Register

NCT02926391 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2023-05-03

No results posted yet for this study

Summary

Multicenter study allowing to include the first sixty patients implanted with a custom-made corpectomy implant (UNiD 3D VBR): 30 patient implanted in cervical region and 30 patients implanted in thoracolumbar region.

The main objective is to confirm feasibilty and safety of patient-specific implants for one or multi-level corpectomy and fusion.

This study was approved in March 2016 allowing to include retrospectivley all patients since the first implantation in January 2015 and prospectively all patients after the approval.

Conditions

  • Spinal Cord Compression
  • Spondylosis
  • Ossification of Posterior Longitudinal Ligament
  • Spinal Neoplasms
  • Bone Disease, Infectious

Interventions

DEVICE

UNiD 3D VBR

Corpectomy of one or several vertebral body(ies) followed by vertebral body(ies) replacement and fusion

Sponsors & Collaborators

  • Medicrea International

    lead INDUSTRY

Principal Investigators

  • Jean-Edouard Loret, MD · CHU Tours

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02926391 on ClinicalTrials.gov