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

Centre Hospitalier Universitaire de Nice

Status and phase: Completed; Phase 4

Conditions: Clinical Radiculopathy; Myelopathy Due to a Cervical Disk Disease

Treatments: Procedure: arthrodesis - cervical disk surgery; Device: cervical disc prosthesis with a mobile insert named Mobi-C

Study type: Interventional

Funder types: Other

Identifiers

NCT00554528

06-APN-01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 200 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

A

Other group

Description:

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

Treatment:

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

B

Other group

Description:

patient receiving intersomatic cage

Treatment:

Procedure: arthrodesis - cervical disk surgery