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

Condition(s) targeted: Clinical Radiculopathy; Myelopathy Due to a Cervical Disk Disease

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

Phase: Phase 4

Status: Recruiting

Sponsored by: Centre Hospitalier Universitaire de Nice

Official(s) and/or principal investigator(s):
Stephane LITRICO, Dr, Principal Investigator, Affiliation: CHU de Nice

Overall contact:
Stephane LITRICO, Dr, Email: litrico.s@chu-nice.fr

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.

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

Study design: Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study

Primary outcome: show significant difference of degeneration of disc above and below the operated stage between the two groups

Secondary outcome:

show difference of neurological pain between the two groups

show difference of duration of hospitalization and consumption of medication

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).

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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

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

Department of Neurosurgery, CHU de Nice, NICE 06000, France; Recruiting
Stéphane LITRICO, Dr, Email: litrico.s@chu-nice.fr
Stephane LITRICO, Dr, Principal Investigator

Related publications:

Dmitriev AE, Cunningham BW, Hu N, Sell G, Vigna F, McAfee PC. Adjacent level intradiscal pressure and segmental kinematics following a cervical total disc arthroplasty: an in vitro human cadaveric model. Spine. 2005 May 15;30(10):1165-72.

Eck JC, Humphreys SC, Lim TH, Jeong ST, Kim JG, Hodges SD, An HS. Biomechanical study on the effect of cervical spine fusion on adjacent-level intradiscal pressure and segmental motion. Spine. 2002 Nov 15;27(22):2431-4.

Hilibrand AS, Robbins M. Adjacent segment degeneration and adjacent segment disease: the consequences of spinal fusion? Spine J. 2004 Nov-Dec;4(6 Suppl):190S-194S. Review.

Goffin J, Geusens E, Vantomme N, Quintens E, Waerzeggers Y, Depreitere B, Van Calenbergh F, van Loon J. Long-term follow-up after interbody fusion of the cervical spine. J Spinal Disord Tech. 2004 Apr;17(2):79-85.

Link HD, McAfee PC, Pimenta L. Choosing a cervical disc replacement. Spine J. 2004 Nov-Dec;4(6 Suppl):294S-302S. Review.

Albert TJ, Eichenbaum MD. Goals of cervical disc replacement. Spine J. 2004 Nov-Dec;4(6 Suppl):292S-293S. Review.

McAfee PC. The indications for lumbar and cervical disc replacement. Spine J. 2004 Nov-Dec;4(6 Suppl):177S-181S. Review.

Fager CA. Cervical arthroplasty. J Neurosurg Spine. 2005 Mar;2(3):394-5; author reply 395. No abstract available.

Phillips FM, Garfin SR. Cervical disc replacement. Spine. 2005 Sep 1;30(17 Suppl):S27-33. Review.

Pracyk JB, Traynelis VC. Treatment of the painful motion segment: cervical arthroplasty. Spine. 2005 Aug 15;30(16 Suppl):S23-32. Review.

Hacker RJ. Cervical disc arthroplasty: a controlled randomized prospective study with intermediate follow-up results. Invited submission from the joint section meeting on disorders of the spine and peripheral nerves, March 2005. J Neurosurg Spine. 2005 Dec;3(6):424-8. Erratum in: J Neurosurg Spine. 2006 Feb;4(2):189.

Robertson JT, Papadopoulos SM, Traynelis VC. Assessment of adjacent-segment disease in patients treated with cervical fusion or arthroplasty: a prospective 2-year study. J Neurosurg Spine. 2005 Dec;3(6):417-23.

Singh M, Gopinath R. Topical analgesia for chest tube removal in cardiac patients. J Cardiothorac Vasc Anesth. 2005 Dec;19(6):719-22.

Chi JH, Ames CP, Tay B. General considerations for cervical arthroplasty with technique for ProDisc-C. Neurosurg Clin N Am. 2005 Oct;16(4):609-19, vi. Review.

Bertagnoli R, Yue JJ, Pfeiffer F, Fenk-Mayer A, Lawrence JP, Kershaw T, Nanieva R. Early results after ProDisc-C cervical disc replacement. J Neurosurg Spine. 2005 Apr;2(4):403-10.

Puttlitz CM, Rousseau MA, Xu Z, Hu S, Tay BK, Lotz JC. Intervertebral disc replacement maintains cervical spine kinetics. Spine. 2004 Dec 15;29(24):2809-14.

Puttlitz CM, DiAngelo DJ. Cervical spine arthroplasty biomechanics. Neurosurg Clin N Am. 2005 Oct;16(4):589-94, v. Review.

Pickett GE, Rouleau JP, Duggal N. Kinematic analysis of the cervical spine following implantation of an artificial cervical disc. Spine. 2005 Sep 1;30(17):1949-54.

Parkinson JF, Sekhon LH. Cervical arthroplasty complicated by delayed spontaneous fusion. Case report. J Neurosurg Spine. 2005 Mar;2(3):377-80.

Murray BE, Lopardo HA, Rubeglio EA, Frosolono M, Singh KV. Intrahospital spread of a single gentamicin-resistant, beta-lactamase-producing strain of Enterococcus faecalis in Argentina. Antimicrob Agents Chemother. 1992 Jan;36(1):230-2.

Bertagnoli R, Duggal N, Pickett GE, Wigfield CC, Gill SS, Karg A, Voigt S. Cervical total disc replacement, part two: clinical results. Orthop Clin North Am. 2005 Jul;36(3):355-62.

Pickett GE, Sekhon LH, Sears WR, Duggal N. Complications with cervical arthroplasty. J Neurosurg Spine. 2006 Feb;4(2):98-105.

Starting date: May 2007
Ending date: May 2010
Last updated: April 20, 2009