Arthroplasty Versus Fusion in Anterior Cervical Surgery: Prospective Study of the Impact on the Adjacent Level
Condition: Clinical Radiculopathy; Myelopathy Due to a Cervical Disk Disease
MeSH terms: Radiculopathy; Spinal Cord Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to evaluate the impact of the cervical disk surgery on the
      deterioration of the adjacent levels. The investigators compare the radiological
      deterioration of adjacent levels, at 3 years, in both situation of fusion and arthroplasty.
      220 patients are enrolled and randomized to receive fusion or prosthesis. Radiological and
      clinical follow-up is organized for a period of 3 years.
    

Detailed description: 
      Anterior surgery of the cervical spine is one of the most practiced procedures in spine
      surgery. Its immediate accuracy and safety is proved since a long time in case of
      degenerative disk disease or disk herniation. But the segmental arthrodesis leads to an
      overload of the adjacent disk. A lot of studies have shown that the increasing mobility and
      pressure of the adjacent segments can be responsible of new degeneration and clinical
      symptoms. Recently, cervical disk prosthesis have been developed to maintain the mobility at
      the level of the surgery. This technique is supposed to decrease the risk of adjacent disk
      disease but, at this time, the analysis of the results is difficult, due to the lack of
      randomized studies with long term follow up.

      The aim of our prospective randomized study is to evaluate the aftermath of the arthroplasty
      compared to the fusion on the adjacent disk degeneration.

      The main objective is to show a radiological difference at 3 years in term of adjacent disk
      degeneration.

      The secondary objectives are:

        -  evaluate the rate of new clinical symptoms during three years

        -  show differences during the postoperative period, especially concerning the length of
           the hospital stay, the use of pain killers and return to work.

        -  verify the maintaining of mobility pf the prosthesis during three years.

      This is a controlled study with two group of equal size: one group is treated by discectomy
      and arthrodesis and the other by discectomy and prosthesis/ The criteria for the inclusion of
      the patients are: clinical radiculopathy and/or myelopathy due to a cervical disk disease
      (disk herniation or osteophytosis), lack of effect of the medical treatment, CT scan or MRI
      showing a compression of roots and/or spinal cord.

      The main exclusion criteria are: plurisegmental disk disease, injuries happened during
      professional activities, previous cervical surgery.

      During the study, we perform a clinical (standardized scales: Neck Disability Index, Short
      Form 36, and neurological exam) and a radiological (height of the adjacent disks,
      ostheophytis,…) follow-up.

      The analysis of the current literature and statistical process leads to a total amount of 220
      patients enrolled in the study. This is a multicentric study organized for a total duration
      of five years (two years for inclusions and three years of follow-up).
    

Intervention name(s): cervical disc prosthesis with a mobile insert named Mobi-C; arthrodesis - cervical disk surgery
Intervention type(s): Device; Procedure
Intervention description(s): Stage 1: partial discectomy
stage 2: location of the medial axis
stage 3: centering pin
stage 4: installation of the caspar spacer
stage 5: total discectomy
stage 6: parallel distraction
stage 7: depth measurement
stage 8: trial implant
stage 9: assembly
stage 10: implant insertion
stage 11: anchorage optimization; discectomy and arthrodesis
Intervention MeSH terms: Meloxicam
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cervical; disc; prosthesis; adjacent; disease; randomized; prospective; study