Clinical trial · Observational
UNiD 3D VBR Register
Evaluation of Safety and Efficency of Custom-made Corpectomy Implants: UNiD 3D VBR
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Disease, Infectious | — | UNRESOLVED | — |
| Ossification of Posterior Longitudinal Ligament | — | UNRESOLVED | — |
| Spinal Cord Compression | — | UNRESOLVED | — |
| Spinal Neoplasms | Spinal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Spondylosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| UNiD 3D VBR | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cervical
- description
- 30 patients who need anterior cervical corpectomy and fusion with patient-specific implants (UNiD 3D VBR)
- interventionNames
- Device: UNiD 3D VBR
- label
- Thoraco-lumbar
- description
- 30 patients who need anterior thoracolumbar corpectomy and fusion with patient-specific implants (UNiD 3D VBR)
- interventionNames
- Device: UNiD 3D VBR
Primary outcomes (1)
- measure
- Quantification and description of implant-related adverse events
- timeFrame
- 12 months
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 useReferences
Publications (0)
Data not yet available