UNiD 3D VBR Register

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

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.

Study Overview

• Status: Completed
• Conditions: Spondylosis; Spinal Neoplasms; Spinal Cord Compression; Ossification of Posterior Longitudinal Ligament; Bone Disease, Infectious
• Intervention / Treatment: Device: UNiD 3D VBR

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

• Study Contact: Name: Estelle Douceron, PhD; Email: clinicalstudy@medicrea.com

Study Locations

• France
  • Tours, France
    • Chu Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who need single or multilevel corpectomy and fusion and who received a patient specific implants UNiD 3D VBR

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medicrea International
• Investigators: Principal Investigator: Jean-Edouard Loret, MD, Chu Tours

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: June 27, 2016
• First Submitted That Met QC Criteria: October 5, 2016
• First Posted (Estimate): October 6, 2016

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Wounds and Injuries; Disease Attributes; Musculoskeletal Diseases; Spinal Cord Diseases; Spinal Diseases; Bone Neoplasms; Spinal Cord Injuries; Ossification, Heterotopic; Infections; Communicable Diseases; Bone Diseases; Spondylosis; Spinal Neoplasms; Bone Diseases, Infectious; Ossification of Posterior Longitudinal Ligament; Spinal Cord Compression
• Other Study ID Numbers: 1801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No