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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00554528
First received: November 5, 2007
Last updated: December 8, 2011
Last verified: December 2011
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Arthroplasty Versus Fusion in Anterior Cervical Surgery: Prospective Study of the Impact on the Adjacent Level

Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • show significant difference of degeneration of disc above and below the operated stage between the two groups [ Time Frame: 3 years after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • show difference of neurological pain between the two groups [ Time Frame: during the 3 years of follow-up ] [ Designated as safety issue: No ]
  • show difference of duration of hospitalization and consumption of medication [ Time Frame: during the first month after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: May 2007
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

B
patient receiving intersomatic cage
Procedure: arthrodesis - cervical disk surgery
discectomy and arthrodesis

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).

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00554528

Contacts
Contact: Stephane LITRICO, Dr litrico.s@chu-nice.fr

Locations
France
Department of Neurosurgery, CHU de Nice Recruiting
Nice, France, 06000
Contact: Stéphane LITRICO, Dr       litrico.s@chu-nice.fr   
Principal Investigator: Stephane LITRICO, Dr         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Stephane LITRICO, Dr CHU de Nice
  More Information

Publications:

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT00554528     History of Changes
Other Study ID Numbers: 06-APN-01
Study First Received: November 5, 2007
Last Updated: December 8, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority
France: Institutional Ethical Committee

Keywords provided by Centre Hospitalier Universitaire de Nice:
Cervical
disc
prosthesis
adjacent
disease
randomized
prospective
study

Additional relevant MeSH terms:
Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 16, 2014