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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervical | 30 patients who need anterior cervical corpectomy and fusion with patient-specific implants (UNiD 3D VBR) |
| |
| Thoraco-lumbar | 30 patients who need anterior thoracolumbar corpectomy and fusion with patient-specific implants (UNiD 3D VBR) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UNiD 3D VBR | Device | Corpectomy of one or several vertebral body(ies) followed by vertebral body(ies) replacement and fusion |
|
| 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 |
| 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 |
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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
Thoracolumbar region
Patients > 18 years
Patients who signed an Informed Consent Form
Exclusion Criteria:
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Patients who need single or multilevel corpectomy and fusion and who received a patient specific implants UNiD 3D VBR
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Edouard Loret, MD | CHU Tours | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Tours | Tours | France |
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| ID | Term |
|---|---|
| D013117 | Spinal Cord Compression |
| D055009 | Spondylosis |
| D017887 | Ossification of Posterior Longitudinal Ligament |
| D013125 | Spinal Neoplasms |
| D001850 | Bone Diseases, Infectious |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013119 | Spinal Cord Injuries |
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|
| 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 |
| D014947 | Wounds and Injuries |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009999 | Ossification, Heterotopic |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001859 | Bone Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D007239 | Infections |