Clinical Trial: UNiD 3D VBR Register

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Evaluation of Safety and Efficency of Custom-made Corpectomy Implants: UNiD 3D VBR

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.


Detailed Summary: 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.
Sponsor: Medicrea International

Current 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Fusion status [ Time Frame: 6, 12, 24 months ]
    Radiological assessment of bony fusion
  • Length of surgery [ Time Frame: During surgery ]
    Surgeon questionnaire will be used to quantify surgery's length
  • Surgical metrics [ Time Frame: During surgery ]
    Surgeon questionnaire will be used to describe the surgery
  • Quality of life [ Time Frame: preoperatively and 6,12, and 24 months postoperation ]
    mJOA: Modified Japanese Orthopaedic Association Score
  • Quality of life [ Time Frame: preoperatively and 6,12, and 24 months postoperation ]
    EMS: European Myelopathy Score
  • Pain [ Time Frame: preoperatively and 6,12, and 24 months postoperation ]
    Visual Analog Score
  • Disability [ Time Frame: preoperatively and 6,12, and 24 months postoperation ]
    Neck disability index
  • Variation of radiological vertebral heights [ Time Frame: 6,12, 24 months ]
    Xrays assessment of segmental height operated
  • Variation of radiological vertebral angulation [ Time Frame: 6,12, 24 months postoperativley ]
    Xrays assessment of C2C7 angle and corpectomy angles


Original Secondary Outcome: Same as current

Information By: Medicrea International

Dates:
Date Received: June 27, 2016
Date Started: June 2016
Date Completion: September 2020
Last Updated: October 5, 2016
Last Verified: October 2016