UNiD 3D VBR Register

Medicrea

Status: Completed

Conditions: Bone Disease, Infectious; Ossification of Posterior Longitudinal Ligament; Spinal Neoplasms; Spinal Cord Compression; Spondylosis

Treatments: Device: UNiD 3D VBR

Study type: Observational

Funder types: Industry

Identifiers

NCT02926391

1801

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients who underwent a single or multilevel cervical or thoracolumbar coprectomy and implanted with a patient specific implant (UNiD 3D VBR) for the following indications:

   • Cervical region

     • Fracture / Trauma
     • Tumors
     • Cervical spondylotic myelopathy
     • Infection (Ex: Osteomyelitis)
     • Spinal instability
     • Symptomatic degenerative spinal disease
     • Inflammatory rheumatism.
     • Pseudarthrosis

   • Thoracolumbar region

     • Fracture / Trauma
     • Tumors
     • Infection (Ex: Osteomyelitis)
     • Spinal instability
     • Symptomatic degenerative spinal disease
     • Pseudarthrosis

2. Patients > 18 years

3. Patients who signed an Informed Consent Form

Exclusion criteria

1. Patients who can't or doesn't want to sign an ICF
2. Patients unable to fill HRQOL questionnaires
3. Non-compliant paitents regarding follow-up or protocol
4. Pregnant patient or intended to be pregnant within the next 2 years
5. Sytemic or local infection
6. Allergy known or suspected to a componant
7. Patients presenting a contraindication as indicated in the instruction for use

Trial design

12 participants in 2 patient groups

Cervical

Description:

30 patients who need anterior cervical corpectomy and fusion with patient-specific implants (UNiD 3D VBR)

Treatment:

Device: UNiD 3D VBR

Thoraco-lumbar

Description:

30 patients who need anterior thoracolumbar corpectomy and fusion with patient-specific implants (UNiD 3D VBR)

Treatment:

Device: UNiD 3D VBR