An observational study in Spinal Cord Compression, Spondylosis and Ossification of Posterior Longitudinal Ligament, sponsored by Medicrea International. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-03.
Sponsored by Medicrea International (part of Medtronic) · Observational
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.
52 studies on the registry are indexed under Spinal Cord Compression; 19 are open to participants now.
This study's enrollment of 12 is below the median of 70 across 17 observational studies indexed under Spinal Cord Compression.
Browse Spinal Cord Compression studies →Medicrea International is the lead sponsor of 8 studies on the registry; none are open to participants now.
First submitted before Medicrea International became part of Medtronic.
Counted across the registry records on this site, refreshed daily.
Patients who need single or multilevel corpectomy and fusion and who received a patient specific implants UNiD 3D VBR
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
30 patients who need anterior cervical corpectomy and fusion with patient-specific implants (UNiD 3D VBR)
Device: UNiD 3D VBR
30 patients who need anterior thoracolumbar corpectomy and fusion with patient-specific implants (UNiD 3D VBR)
Device: UNiD 3D VBR
Corpectomy of one or several vertebral body(ies) followed by vertebral body(ies) replacement and fusion
Also known as: Patient-specific corpectomy implants, Custom-made corpectomy implants
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
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2016 to primary completion in Mar 2018, 17 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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