Trials / Completed
CompletedNCT02926391
UNiD 3D VBR Register
Evaluation of Safety and Efficency of Custom-made Corpectomy Implants: UNiD 3D VBR
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 12 (actual)
- Sponsor
- Medicrea International · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Spinal Cord Compression
- Spondylosis
- Ossification of Posterior Longitudinal Ligament
- Spinal Neoplasms
- Bone Disease, Infectious
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | UNiD 3D VBR | Corpectomy of one or several vertebral body(ies) followed by vertebral body(ies) replacement and fusion |
Timeline
- Start date
- 2016-10-01
- Primary completion
- 2018-03-01
- Completion
- 2018-03-01
- First posted
- 2016-10-06
- Last updated
- 2023-05-03
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT02926391. Inclusion in this directory is not an endorsement.