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.
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
12
Corpectomy of one or several vertebral body(ies) followed by vertebral body(ies) replacement and fusion
CHU Tours
Tours, France
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
Time frame: 12 months
Fusion status
Radiological assessment of bony fusion
Time frame: 6, 12, 24 months
Length of surgery
Surgeon questionnaire will be used to quantify surgery's length
Time frame: During surgery
Surgical metrics
Surgeon questionnaire will be used to describe the surgery
Time frame: During surgery
Quality of life
mJOA: Modified Japanese Orthopaedic Association Score
Time frame: preoperatively and 6,12, and 24 months postoperation
Quality of life
EMS: European Myelopathy Score
Time frame: preoperatively and 6,12, and 24 months postoperation
Pain
Visual Analog Score
Time frame: preoperatively and 6,12, and 24 months postoperation
Disability
Neck disability index
Time frame: preoperatively and 6,12, and 24 months postoperation
Variation of radiological vertebral heights
Xrays assessment of segmental height operated
Time frame: 6,12, 24 months
Variation of radiological vertebral angulation
Xrays assessment of C2C7 angle and corpectomy angles
Time frame: 6,12, 24 months postoperativley
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