UNiD 3D VBR Register

Spondylosis Clinical Trial

Official title: Evaluation of Safety and Efficency of Custom-made Corpectomy Implants: UNiD 3D VBR

Status Completed

Clinical Trial 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.

Clinical Trial Description

Anterior cervical corpectomy with fusion (ACCF) has been demonstrated as a good alternative to anterior cervical discectomy and fusion (ACDF) to treat cervical spondylotic myelopathy (CSM). However, the use of vertebral body replacement (VBR) cages is technically demanding, especially to adjust the size of the cage to the defect without compromising the endplate integrity increasing the risk of subsidence. Beside recent studies advocating the interest of the shape, size and design of an implant to achieve fusion and stability in cervical spinal diseases indications, 3D printing offering rapid and patient-specific manufacturing has emerged over the past years. Several materials and technologies can be used and clinical and radiological data are still sparse. ;

Related Conditions & MeSH terms

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

• NCT number: NCT02926391
• Study type: Observational [Patient Registry]
• Source: Medicrea International
• Status: Completed
• Start date: October 2016
• Completion date: March 2018