Clinical RadiculopathyPhase 4PROCERVNCT00554528

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

A Phase 4 study testing cervical disc prosthesis with a mobile insert named Mobi-C and arthrodesis - cervical disk surgery in people with Clinical Radiculopathy and Myelopathy Due to a Cervical Disk Disease, run by Centre Hospitalier Universitaire de Nice at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Clinical Radiculopathy, Myelopathy Due to a Cervical Disk Disease
What is being tested?: cervical disc prosthesis with a mobile insert named Mobi-C and arthrodesis - cervical disk surgery
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 1 siteFrance
Study dates: May 2007to May 2012
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

plurisegmenta disk disease
injuries happened during professional activities
previous cervical surgery

Trial locations and contacts

1 site in 1 country.

France1 site

Department of Neurosurgery, CHU de Nice
Nice, 06000

Other trials in France

About this study

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.

Read the 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).

Conditions: Clinical Radiculopathy, Myelopathy Due to a Cervical Disk Disease
Being tested: cervical disc prosthesis with a mobile insert named Mobi-C, arthrodesis - cervical disk surgery
Keywords: Cervical, disc, prosthesis, adjacent, disease, randomized, prospective, study
Medical subject headings: Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

cervical disc prosthesis with a mobile insert named Mobi-CDevice
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
arthrodesis - cervical disk surgeryProcedure or surgery
discectomy and arthrodesis

Study groups in NCT00554528
Study group	Role	What they receive
A	Other	patient receiving cervical disc prosthesis with a mobile insert named Mobi-C and product by LDR médical Receives: Device: cervical disc prosthesis with a mobile insert named Mobi-C
B	Other	patient receiving intersomatic cage Receives: Procedure: arthrodesis - cervical disk surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

show difference of neurological pain between the two groups
Measured: during the 3 years of follow-up
show difference of duration of hospitalization and consumption of medication
Measured: during the first month after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2007May 2012

First posted7 Nov 2007 (estimated)
Study startMay 2007
Primary completionMay 2012
Study completionMay 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (22)Papers the sponsor has linked to this study.
Other trials for Clinical RadiculopathyStudies of the same condition, open and under way.
More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00554528
Sponsor's protocol ID: 06-APN-01
Acronym: PROCERV
Status last verified: Sep 2015
First submitted: 5 Nov 2007
Last updated: 30 Sep 2015
Results posted: No
Data monitoring committee: No

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 (Phila Pa 1976). 2005 May 15;30(10):1165-72. doi: 10.1097/01.brs.0000162441.23824.95.
PubMed 15897831
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. doi: 10.1097/00007632-200211150-00003.
PubMed 12435970
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. doi: 10.1016/j.spinee.2004.07.007.
PubMed 15541666
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. doi: 10.1097/00024720-200404000-00001.
PubMed 15260088
Link HD, McAfee PC, Pimenta L. Choosing a cervical disc replacement. Spine J. 2004 Nov-Dec;4(6 Suppl):294S-302S. doi: 10.1016/j.spinee.2004.07.022.
PubMed 15541680
Albert TJ, Eichenbaum MD. Goals of cervical disc replacement. Spine J. 2004 Nov-Dec;4(6 Suppl):292S-293S. doi: 10.1016/j.spinee.2004.07.023.
PubMed 15541679
McAfee PC. The indications for lumbar and cervical disc replacement. Spine J. 2004 Nov-Dec;4(6 Suppl):177S-181S. doi: 10.1016/j.spinee.2004.07.003.
PubMed 15541664
Fager CA. Cervical arthroplasty. J Neurosurg Spine. 2005 Mar;2(3):394-5; author reply 395. doi: 10.3171/spi.2005.2.3.0394. No abstract available.
PubMed 15796370
Phillips FM, Garfin SR. Cervical disc replacement. Spine (Phila Pa 1976). 2005 Sep 1;30(17 Suppl):S27-33. doi: 10.1097/01.brs.0000175192.55139.69.
PubMed 16138062
Pracyk JB, Traynelis VC. Treatment of the painful motion segment: cervical arthroplasty. Spine (Phila Pa 1976). 2005 Aug 15;30(16 Suppl):S23-32. doi: 10.1097/01.brs.0000174507.45083.98.
PubMed 16103831
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. doi: 10.3171/spi.2005.3.6.0424.
PubMed 16381203
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. doi: 10.3171/spi.2005.3.6.0417.
PubMed 16381202
Singh M, Gopinath R. Topical analgesia for chest tube removal in cardiac patients. J Cardiothorac Vasc Anesth. 2005 Dec;19(6):719-22. doi: 10.1053/j.jvca.2005.07.024.
PubMed 16326294
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. doi: 10.1016/j.nec.2005.07.001.
PubMed 16326284
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. doi: 10.3171/spi.2005.2.4.0403.
PubMed 15871478

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Arthroplasty Versus Fusion in Anterior Cervical Surgery: Prospective Study of the Impact on the Adjacent Level
ClinicalTrials.gov ID: NCT00554528
Acronym / sponsor ID: PROCERV / 06-APN-01
Conditions: Clinical Radiculopathy, Myelopathy Due to a Cervical Disk Disease
Keywords: Cervical, disc, prosthesis, adjacent, disease, randomized, prospective, study
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Centre Hospitalier Universitaire de NiceUniversity, hospital or other
Study start: May 2007
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 7 Nov 2007 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

The main exclusion criteria are: plurisegmental disk disease, injuries happened during professional activities, previous cervical surgery.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
A	Other	Device: cervical disc prosthesis with a mobile insert named Mobi-Cpatient receiving cervical disc prosthesis with a mobile insert named Mobi-C and product by LDR médical
B	Other	Procedure: arthrodesis - cervical disk surgerypatient receiving intersomatic cage

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

plurisegmenta disk disease
injuries happened during professional activities
previous cervical surgery

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
cervical disc prosthesis with a mobile insert named Mobi-CStage 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	Device	A
arthrodesis - cervical disk surgerydiscectomy and arthrodesis	Procedure or surgery	B

Primary outcome

show significant difference of degeneration of disc above and below the operated stage between the two groups
Time frame: 3 years after surgery

2 secondary outcomes

show difference of neurological pain between the two groups
Time frame: during the 3 years of follow-up
show difference of duration of hospitalization and consumption of medication
Time frame: during the first month after surgery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2015.
Background: PubMed 15897831Dmitriev 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. doi: 10.1097/01.brs.0000162441.23824.95.
Background: PubMed 12435970Eck 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. doi: 10.1097/00007632-200211150-00003.
Background: PubMed 15541666Hilibrand 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. doi: 10.1016/j.spinee.2004.07.007.
Background: PubMed 15260088Goffin 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. doi: 10.1097/00024720-200404000-00001.
Background: PubMed 15541680Link HD, McAfee PC, Pimenta L. Choosing a cervical disc replacement. Spine J. 2004 Nov-Dec;4(6 Suppl):294S-302S. doi: 10.1016/j.spinee.2004.07.022.
Background: PubMed 15541679Albert TJ, Eichenbaum MD. Goals of cervical disc replacement. Spine J. 2004 Nov-Dec;4(6 Suppl):292S-293S. doi: 10.1016/j.spinee.2004.07.023.
Background: PubMed 15541664McAfee PC. The indications for lumbar and cervical disc replacement. Spine J. 2004 Nov-Dec;4(6 Suppl):177S-181S. doi: 10.1016/j.spinee.2004.07.003.
Background: PubMed 15796370Fager CA. Cervical arthroplasty. J Neurosurg Spine. 2005 Mar;2(3):394-5; author reply 395. doi: 10.3171/spi.2005.2.3.0394. No abstract available.
Background: PubMed 16138062Phillips FM, Garfin SR. Cervical disc replacement. Spine (Phila Pa 1976). 2005 Sep 1;30(17 Suppl):S27-33. doi: 10.1097/01.brs.0000175192.55139.69.
Background: PubMed 16103831Pracyk JB, Traynelis VC. Treatment of the painful motion segment: cervical arthroplasty. Spine (Phila Pa 1976). 2005 Aug 15;30(16 Suppl):S23-32. doi: 10.1097/01.brs.0000174507.45083.98.
Background: PubMed 16381203Hacker 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. doi: 10.3171/spi.2005.3.6.0424.
Background: PubMed 16381202Robertson 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. doi: 10.3171/spi.2005.3.6.0417.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Stephane LITRICO, Dr principal investigator

Centre Hospitalier Universitaire de Nice

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

show significant difference of degeneration of disc above and below the operated stage between the two groups (time frame: 3 years after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00554528, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2015.