Spinal Cord CompressionNCT02926391
UNiD 3D VBR Register
An observational study of Spinal Cord Compression and Spondylosis, run by Medicrea International at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Compression, Spondylosis, Ossification of Posterior Longitudinal Ligament
- What is being tested?
- UNiD 3D VBR
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2016to Mar 2018
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who need single or multilevel corpectomy and fusion and who received a patient specific implants UNiD 3D VBR
Who may be able to join
- 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)
Show all 19Show fewer
- Spinal instability
- Symptomatic degenerative spinal disease
- Inflammatory rheumatism.
- Pseudarthrosis
- Thoracolumbar region
- Fracture / Trauma
- Tumors
- Infection (Ex: Osteomyelitis)
- Spinal instability
- Symptomatic degenerative spinal disease
- Pseudarthrosis
- Patients > 18 years
- Patients who signed an Informed Consent Form
Who cannot join
- Patients who can't or doesn't want to sign an ICF
- Patients unable to fill HRQOL questionnaires
- Non-compliant paitents regarding follow-up or protocol
- Pregnant patient or intended to be pregnant within the next 2 years
- Sytemic or local infection
- Allergy known or suspected to a componant
- Patients presenting a contraindication as indicated in the instruction for use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Safety and Efficency of Custom-made Corpectomy Implants: UNiD 3D VBR
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.
Read the 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
- Being tested
- UNiD 3D VBR
- Medical subject headings
- Spinal Cord Compression, Spondylosis, Ossification of Posterior Longitudinal Ligament, Spinal Neoplasms, Bone Diseases, Infectious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UNiD 3D VBRDevice
Also called Patient-specific corpectomy implants, Custom-made corpectomy implants
Corpectomy of one or several vertebral body(ies) followed by vertebral body(ies) replacement and fusion
| Study group | Role | What they receive |
|---|---|---|
| Cervical | 30 patients who need anterior cervical corpectomy and fusion with patient-specific implants (UNiD 3D VBR) Receives: Device: UNiD 3D VBR | |
| Thoraco-lumbar | 30 patients who need anterior thoracolumbar corpectomy and fusion with patient-specific implants (UNiD 3D VBR) Receives: Device: UNiD 3D VBR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (9)
Fusion status
Radiological assessment of bony fusion
Measured: 6, 12, 24 months
Length of surgery
Surgeon questionnaire will be used to quantify surgery's length
Measured: During surgery
Surgical metrics
Surgeon questionnaire will be used to describe the surgery
Measured: During surgery
Quality of life
mJOA: Modified Japanese Orthopaedic Association Score
Measured: preoperatively and 6,12, and 24 months postoperation
Quality of life
EMS: European Myelopathy Score
Measured: preoperatively and 6,12, and 24 months postoperation
Pain
Visual Analog Score
Measured: preoperatively and 6,12, and 24 months postoperation
Disability
Neck disability index
Measured: preoperatively and 6,12, and 24 months postoperation
Variation of radiological vertebral heights
Xrays assessment of segmental height operated
Measured: 6,12, 24 months
Variation of radiological vertebral angulation
Xrays assessment of C2C7 angle and corpectomy angles
Measured: 6,12, 24 months postoperativley
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord CompressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Medicrea International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Edouard Loret, MD, Principal investigator, CHU Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926391
- Sponsor's protocol ID
- 1801
- Status last verified
- May 2023
- First submitted
- 27 Jun 2016
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficency of Custom-made Corpectomy Implants: UNiD 3D VBR
- ClinicalTrials.gov ID
- NCT02926391
- Acronym / sponsor ID
- 1801
- Conditions
- Spinal Cord Compression, Spondylosis, Ossification of Posterior Longitudinal Ligament, Spinal Neoplasms, Bone Disease, Infectious
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Medicrea InternationalIndustry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical | – | Device: UNiD 3D VBR30 patients who need anterior cervical corpectomy and fusion with patient-specific implants (UNiD 3D VBR) |
| Thoraco-lumbar | – | Device: UNiD 3D VBR30 patients who need anterior thoracolumbar corpectomy and fusion with patient-specific implants (UNiD 3D VBR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who need single or multilevel corpectomy and fusion and who received a patient specific implants UNiD 3D VBR
Key inclusion criteria (19 listed)
- 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:
- Patients > 18 years
- Patients who signed an Informed Consent Form
Key exclusion criteria (7 listed)
- Patients who can't or doesn't want to sign an ICF
- Patients unable to fill HRQOL questionnaires
- Non-compliant paitents regarding follow-up or protocol
- Pregnant patient or intended to be pregnant within the next 2 years
- Sytemic or local infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UNiD 3D VBRAlso: Patient-specific corpectomy implants, Custom-made corpectomy implantsCorpectomy of one or several vertebral body(ies) followed by vertebral body(ies) replacement and fusion | Device | Cervical, Thoraco-lumbar |
Primary outcome
Quantification and description of implant-related adverse events
Time frame: 12 months
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
9 secondary outcomes
Fusion status
Time frame: 6, 12, 24 months
Length of surgery
Time frame: During surgery
Surgical metrics
Time frame: During surgery
Quality of life
Time frame: preoperatively and 6,12, and 24 months postoperation
Quality of life
Time frame: preoperatively and 6,12, and 24 months postoperation
Pain
Time frame: preoperatively and 6,12, and 24 months postoperation
Disability
Time frame: preoperatively and 6,12, and 24 months postoperation
Variation of radiological vertebral heights
Time frame: 6,12, 24 months
Variation of radiological vertebral angulation
Time frame: 6,12, 24 months postoperativley
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Edouard Loret, MD principal investigator
CHU Tours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Compression and Spondylosis, run by Medicrea International at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification and description of implant-related adverse events (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.