UNiD 3D VBR Register

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

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

Intervention / Treatment
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* Device: UNiD 3D VBR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Patients > 18 years Patients who signed an Informed Consent Form Exclusion Criteria: Patients who can't or doesn't want to sign an ICF Patients unable to fill HRQOL questionnaires Non-compliant paitents regarding follow-up or protocol Pregnant patient or intended to be pregnant within the next 2 years Sytemic or local infection Allergy known or suspected to a componant Patients presenting a contraindication as indicated in the instruction for use

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cervical<br>30 patients who need anterior cervical corpectomy and fusion with patient-specific implants (UNiD 3D VBR) | Device: UNiD 3D VBR<br>* Corpectomy of one or several vertebral body(ies) followed by vertebral body(ies) replacement and fusion<br>* Other names: Custom-made corpectomy implants;|
| Thoraco-lumbar<br>30 patients who need anterior thoracolumbar corpectomy and fusion with patient-specific implants (UNiD 3D VBR) | Device: UNiD 3D VBR<br>* Corpectomy of one or several vertebral body(ies) followed by vertebral body(ies) replacement and fusion<br>* Other names: Custom-made corpectomy implants;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification and description of implant-related adverse events | To confirm the safety of the surgery with patient specfic implant (UNiD 3D VBR). To quantify and describe adverse events or revision surgeries occuring during follow-up | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion status | Radiological assessment of bony fusion | 6, 12, 24 months | 
| Length of surgery | Surgeon questionnaire will be used to quantify surgery's length | During surgery | 
| Surgical metrics | Surgeon questionnaire will be used to describe the surgery | During surgery | 
| Quality of life | mJOA: Modified Japanese Orthopaedic Association Score | preoperatively and 6,12, and 24 months postoperation | 
| Quality of life | EMS: European Myelopathy Score | preoperatively and 6,12, and 24 months postoperation | 
| Pain | Visual Analog Score | preoperatively and 6,12, and 24 months postoperation | 
| Disability | Neck disability index | preoperatively and 6,12, and 24 months postoperation | 
| Variation of radiological vertebral heights | Xrays assessment of segmental height operated | 6,12, 24 months | 
| Variation of radiological vertebral angulation | Xrays assessment of C2C7 angle and corpectomy angles | 6,12, 24 months postoperativley |