Arthroplasty Versus Fusion in Anterior Cervical Surgery: Prospective Study of the Impact on the Adjacent Level

Phase 4

Completed

• Conditions: Clinical Radiculopathy; Myelopathy Due to a Cervical Disk Disease
• Interventions: Procedure: arthrodesis - cervical disk surgery; Device: cervical disc prosthesis with a mobile insert named Mobi-C

• Registration Number: NCT00554528
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief 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).

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-11-05
• Study First Submitted QC: 2007-11-05
• Study First Posted: 2007-11-07
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-29
• Last Update Posted: 2015-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• clinical radiculopathy
• myelopathy due to a cervical disk disease
• lack of effect of the medical treatment
• CT scan or MRI showing a compression of roots and/or spinal cord

Exclusion Criteria

• plurisegmenta disk disease
• injuries happened during professional activities
• previous cervical surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
B	arthrodesis - cervical disk surgery	patient receiving intersomatic cage
A	cervical disc prosthesis with a mobile insert named Mobi-C	patient receiving cervical disc prosthesis with a mobile insert named Mobi-C and product by LDR médical

Primary Outcome Measures

Name	Time	Method
show significant difference of degeneration of disc above and below the operated stage between the two groups	3 years after surgery

Secondary Outcome Measures

Name	Time	Method
show difference of neurological pain between the two groups	during the 3 years of follow-up
show difference of duration of hospitalization and consumption of medication	during the first month after surgery

Trial Locations

Locations (1)

Department of Neurosurgery, CHU de Nice; 🇫🇷 Nice, France