UNiD 3D VBR Register

Spondylosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02926391
• Other study ID #: 1801
• Status: Completed
• Start date: October 2016
• Est. completion date: March 2018

Study information

• Verified date: May 2023
• Source: Medicrea International
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Intervention

Device:
• UNiD 3D VBR
Corpectomy of one or several vertebral body(ies) followed by vertebral body(ies) replacement and fusion

Locations

Country	Name	City	State
France	CHU Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Medicrea International

Country where clinical trial is conducted

France, 

Outcome

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