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

Sponsor

Centre Hospitalier Universitaire de Nice (Other)

Overall Status

Completed

CT.gov ID

NCT00554528

Collaborator

(none)

200

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Clinical Radiculopathy Myelopathy Due to a Cervical Disk Disease	Device: cervical disc prosthesis with a mobile insert named Mobi-C Procedure: arthrodesis - cervical disk surgery	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2007

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: A patient receiving cervical disc prosthesis with a mobile insert named Mobi-C and product by LDR médical	Device: cervical disc prosthesis with a mobile insert named Mobi-C 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
Other: B patient receiving intersomatic cage	Procedure: arthrodesis - cervical disk surgery discectomy and arthrodesis

Arm

Intervention/Treatment

Other: A

patient receiving cervical disc prosthesis with a mobile insert named Mobi-C and product by LDR médical

Device: cervical disc prosthesis with a mobile insert named Mobi-C

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

Other: B

patient receiving intersomatic cage

Procedure: arthrodesis - cervical disk surgery

discectomy and arthrodesis

Outcome Measures

Primary Outcome Measures

show significant difference of degeneration of disc above and below the operated stage between the two groups [3 years after surgery]

Secondary Outcome Measures

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]