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

Clinical Radiculopathy Clinical Trial

— PROCERV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00554528
• Other study ID #: 06-APN-01
• Status: Completed
• Phase: Phase 4
• First received: November 5, 2007
• Last updated: September 29, 2015
• Start date: May 2007
• Est. completion date: May 2012

Study information

• Verified date: September 2015
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection AuthorityFrance: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clinical Radiculopathy
• Myelopathy Due to a Cervical Disk Disease
• Radiculopathy

Intervention

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

Procedure:
• arthrodesis - cervical disk surgery
discectomy and arthrodesis

Locations

Country	Name	City	State
France	Department of Neurosurgery, CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

References & Publications (22)

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

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. — View Citation

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. — View Citation

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. — View Citation

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 (Phila Pa 1976). 2005 May 15;30(10):1165-72. — View Citation

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 (Phila Pa 1976). 2002 Nov 15;27(22):2431-4. — View Citation

Fager CA. Cervical arthroplasty. J Neurosurg Spine. 2005 Mar;2(3):394-5; author reply 395. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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

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. — View Citation

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

Phillips FM, Garfin SR. Cervical disc replacement. Spine (Phila Pa 1976). 2005 Sep 1;30(17 Suppl):S27-33. Review. — View Citation

Pickett GE, Rouleau JP, Duggal N. Kinematic analysis of the cervical spine following implantation of an artificial cervical disc. Spine (Phila Pa 1976). 2005 Sep 1;30(17):1949-54. — View Citation

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

Pracyk JB, Traynelis VC. Treatment of the painful motion segment: cervical arthroplasty. Spine (Phila Pa 1976). 2005 Aug 15;30(16 Suppl):S23-32. Review. — View Citation

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

Puttlitz CM, Rousseau MA, Xu Z, Hu S, Tay BK, Lotz JC. Intervertebral disc replacement maintains cervical spine kinetics. Spine (Phila Pa 1976). 2004 Dec 15;29(24):2809-14. — View Citation

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. — View Citation

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

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	show significant difference of degeneration of disc above and below the operated stage between the two groups		3 years after surgery	No
Secondary	show difference of neurological pain between the two groups		during the 3 years of follow-up	No
Secondary	show difference of duration of hospitalization and consumption of medication		during the first month after surgery	No