Clinical trial NCT02926391: UNiD 3D VBR Register
Official title: Evaluation of Safety and Efficency of Custom-made Corpectomy Implants: UNiD 3D VBR
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Compression
Spondylosis
Ossification of Posterior Longitudinal Ligament
Spinal Neoplasms
Bone Disease, Infectious
Lead sponsor: Medicrea International
Sponsor class: INDUSTRY
First posted: 2016-10-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quantification and description of implant-related adverse events
timeFrame: 12 months
Secondary outcomes:
measure: Fusion status
timeFrame: 6, 12, 24 months
measure: Length of surgery
timeFrame: During surgery
measure: Surgical metrics
timeFrame: During surgery
measure: Quality of life
timeFrame: preoperatively and 6,12, and 24 months postoperation
measure: Quality of life
timeFrame: preoperatively and 6,12, and 24 months postoperation
measure: Pain
timeFrame: preoperatively and 6,12, and 24 months postoperation
measure: Disability
timeFrame: preoperatively and 6,12, and 24 months postoperation
measure: Variation of radiological vertebral heights
timeFrame: 6,12, 24 months
measure: Variation of radiological vertebral angulation
timeFrame: 6,12, 24 months postoperativley
Other outcomes:
Locations:
city: Tours
country: France
facility: CHU Tours
Study officials:
affiliation: CHU Tours
name: Jean-Edouard Loret, MD
role: PRINCIPAL_INVESTIGATOR
References: