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UNiD 3D VBR Register

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ClinicalTrials.gov Identifier: NCT02926391
Recruitment Status : Recruiting
First Posted : October 6, 2016
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Medicrea International

Brief 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.


Condition or disease Intervention/treatment
Spinal Cord Compression Spondylosis Ossification of Posterior Longitudinal Ligament Spinal Neoplasms Bone Disease, Infectious Device: UNiD 3D VBR

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: Evaluation of Safety and Efficency of Custom-made Corpectomy Implants: UNiD 3D VBR
Study Start Date : June 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : September 2020

Group/Cohort Intervention/treatment
Cervical
30 patients who need anterior cervical 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
Other Names:
  • Patient-specific corpectomy implants
  • Custom-made corpectomy implants

Thoraco-lumbar
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
Other Names:
  • Patient-specific corpectomy implants
  • Custom-made corpectomy implants




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Fusion status [ Time Frame: 6, 12, 24 months ]
    Radiological assessment of bony fusion

  2. Length of surgery [ Time Frame: During surgery ]
    Surgeon questionnaire will be used to quantify surgery's length

  3. Surgical metrics [ Time Frame: During surgery ]
    Surgeon questionnaire will be used to describe the surgery

  4. Quality of life [ Time Frame: preoperatively and 6,12, and 24 months postoperation ]
    mJOA: Modified Japanese Orthopaedic Association Score

  5. Quality of life [ Time Frame: preoperatively and 6,12, and 24 months postoperation ]
    EMS: European Myelopathy Score

  6. Pain [ Time Frame: preoperatively and 6,12, and 24 months postoperation ]
    Visual Analog Score

  7. Disability [ Time Frame: preoperatively and 6,12, and 24 months postoperation ]
    Neck disability index

  8. Variation of radiological vertebral heights [ Time Frame: 6,12, 24 months ]
    Xrays assessment of segmental height operated

  9. Variation of radiological vertebral angulation [ Time Frame: 6,12, 24 months postoperativley ]
    Xrays assessment of C2C7 angle and corpectomy angles



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who need single or multilevel corpectomy and fusion and who received a patient specific implants UNiD 3D VBR
Criteria

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 use

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02926391


Contacts
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Contact: Estelle Douceron, PhD clinicalstudy@medicrea.com

Locations
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France
CHU Tours Recruiting
Tours, France
Contact: Jean-Eouard Loret, MD         
Sponsors and Collaborators
Medicrea International
Investigators
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Principal Investigator: Jean-Edouard Loret, MD CHU Tours

Additional Information:

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Responsible Party: Medicrea International
ClinicalTrials.gov Identifier: NCT02926391     History of Changes
Other Study ID Numbers: 1801
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Bone Diseases
Spondylosis
Spinal Cord Compression
Communicable Diseases
Infection
Spinal Neoplasms
Bone Diseases, Infectious
Ossification of Posterior Longitudinal Ligament
Musculoskeletal Diseases
Spinal Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Injuries
Wounds and Injuries
Bone Neoplasms
Neoplasms by Site
Neoplasms
Ossification, Heterotopic
Pathologic Processes