Clinical Radiculopathy Clinical Trial
Official title:
Arthroplasty Versus Fusion in Anterior Cervical Surgery: Prospective Study of the Impact on the Adjacent Level
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.
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).
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment