GRANVIA®-C Cervical Disc Prosthesis Multicenter European Pilot Study

• Composite criterion of success [ Time Frame: 24Months ] [ Designated as safety issue: Yes ]

  the success is defined by a composite criterion of 4 points. The surgery will be a success only if there is:

  • A 15-point improvement in the NDI score from the preoperative baseline score
  • Maintenance or improvement of the pre-op baseline neurological status
  • Absence of secondary surgical intervention
  • Absence of serious adverse event
  
  

• Radiologic evaluation of the motion [ Time Frame: Preop, 3M, 12M and 24M ] [ Designated as safety issue: No ]
  Radiologic evaluation of the motion of the operated level(s) and comparison to the motion of the adjacent levels,
  
  
• Evaluation of potential peri and post-operative adverse events related or not to prosthesis. [ Time Frame: preop, 3M, 12M, 24M ] [ Designated as safety issue: Yes ]
  
• Evaluation of satisfaction [ Time Frame: Preop, 3M, 12M and 24M ] [ Designated as safety issue: No ]
  Evaluation of satisfaction with Patient Satisfaction Index
  
  
• Evaluation of the time to return to activities (normal activity, work, sport activity) [ Time Frame: preop, 3M, 12M, 24M ] [ Designated as safety issue: No ]
  
• Evaluation of Pain [ Time Frame: Preop, 3M, 12M and 24M ] [ Designated as safety issue: No ]
  Evaluation of pain with Visual Analog Scales
  
  
• cervical alignment [ Time Frame: Preop, 3M, 12M and 24M ] [ Designated as safety issue: No ]
  Radiologic evaluation of the global cervical alignment
  
  
• disc height [ Time Frame: Preop, 3M, 12M and 24M ] [ Designated as safety issue: No ]
  Radiologic evaluation of the disc height of the operated level(s)
  
  
• Radiologic adverse events [ Time Frame: Preop, 3M, 12M and 24M ] [ Designated as safety issue: No ]
  Radiologic evaluation of adverse events such as migration, subsidence
  
  

Anterior cervical arthrodesis has been widely used to treat the degenerative cervical spine. Although the results of ACDF are generally in the good to excellent range, interbody fusion of the cervical spine after cervical discectomy, aside from causing restriction of neck movements, also accelerates degeneration of adjacent disc levels because of the increased stress from fusion. Long-term radiographic follow-up of patients with anterior cervical fusion has demonstrated degenerative changes in the non-fused segments of the spine including disc space narrowing and osteophyte formation.

To conclude, fusion provokes a functional overload of the discs bordering the fusion that is directly correlated to the number of fused levels. Radiographic observations show a greater mechanical stress on the discs, especially in the arthrodeses involving more than one level.

Artificial discs were designed to replace the entire intervertebral disc and to preserve the physiological motion of the operated level. Several prostheses with different concepts were commercialized. Published clinical studies reported a preserved motion and improved clinical results (Neck Disability Index, Pain Visual Analogic Scale, Quality of Life).

The cervical disc prosthesis GRANVIA®-C was designed to replace the intervertebral discs of the cervical spine, to restore the disc height and to restore segmental motion.

A prospective clinical study has been set up to evaluate the performance of the prosthesis

Granvia-c is a device NOT FDA-approved and NOT under investigation in the USA.