Evaluation of Safety and Efficency of Custom-made Corpectomy Implants: UNiD 3D VBR
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medicrea International
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Quantification and description of implant-related adverse events
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Cervical spondylotic myelopathy
- •Infection (Ex: Osteomyelitis)
- •Spinal instability
- •Symptomatic degenerative spinal disease
- •Inflammatory rheumatism.
- •Pseudarthrosis
- •Thoracolumbar region
- •Fracture / Trauma
- •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
Outcomes
Primary Outcomes
Quantification and description of implant-related adverse events
Time Frame: 12 months
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
Secondary Outcomes
- Variation of radiological vertebral heights(6,12, 24 months)
- Fusion status(6, 12, 24 months)
- Surgical metrics(During surgery)
- Disability(preoperatively and 6,12, and 24 months postoperation)
- Quality of life(preoperatively and 6,12, and 24 months postoperation)
- Length of surgery(During surgery)
- Pain(preoperatively and 6,12, and 24 months postoperation)
- Variation of radiological vertebral angulation(6,12, 24 months postoperativley)