Symptomatic Cervical Disc DiseaseNCT00882661

SECURE®-C Cervical Artificial Disc Clinical Study/ SECURE-C Cervical Artificial Disc Postmarket Approval Study

A study testing SECURE-C Cervical Artificial Disc and ASSURE Cervical plate and an allograft interbody spacer in people with Symptomatic Cervical Disc Disease, run by Globus Medical Inc.

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

The purpose of the pivotal IDE clinical study was to evaluate the safety and effectiveness of the SECURE®-C Cervical Artificial Disc for the treatment of symptomatic cervical disc disease at one level between C3 and C7, compared to anterior cervical discectomy and fusion. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Symptomatic Cervical Disc Disease
What is being tested?: SECURE-C Cervical Artificial Disc and ASSURE Cervical plate and an allograft interbody spacer
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 380 participants
Where: No sites listed yet
Study dates: Jul 2005to Feb 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Symptomatic cervical disc disease (SCDD) in one vertebral level between C3-C7, defined as neck or arm (radicular) pain, or functional or neurological deficit and radiographic confirmation (by CT, MRI, X-ray, etc.) of any of the following:
Herniated nucleus pulposus;
Radiculopathy or myelopathy;
Spondylosis (defined by the presence of osteophytes); or
Loss of disc height.
Age between 18 and 60 years

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Failed at least 6 weeks of conservative treatment
Neck Disability Index (NDI) Questionnaire score of at least 30 (as percentage of 50 point total)
Able to understand and sign informed consent form
Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and filling out forms
Able to meet the proposed follow-up schedule at 6 weeks, 3 months, 6 months, 12 months and 24 months
Able to follow postoperative management program

Who cannot join

More than one vertebral level requiring treatment
Prior fusion surgery adjacent to the vertebral level being treated
Prior surgery at the level to be treated
Clinically compromised vertebral bodies at the affected level(s) due to current or past trauma
Radiographic confirmation of facet joint disease or degeneration, defined as apparent sclerosis and/or hypertrophy of the facets demonstrated on AP radiographs as a disruption of the normally smooth facet curve
Marked cervical instability on resting lateral or flexion/extension radiographs:

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Translation greater than 3mm, and/or
More than 11° of rotational difference from that of either adjacent level.
Severe spondylosis at the level to be treated as characterized by any of the following:
Bridging osteophytes;
A loss of disc height greater than 50%; or
Absence of motion (<2°)
Neck or arm pain of unknown etiology
Osteoporosis, osteopenia, Paget's disease, osteomalacia or any other metabolic bone disease
Pregnant or interested in becoming pregnant in the next 2 years
Active systemic or local infection
Known allergy to titanium, polyethylene, cobalt, chromium or molybdenum
Taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids)
Rheumatoid arthritis or other autoimmune disease
Systemic disease including AIDS, HIV, Hepatitis
Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there has been no clinical signs or symptoms of the malignancy for at least 5 years
Neuromuscular disorders such as muscular dystrophy, spinal muscular atrophy, amyotrophic lateral sclerosis, etc.
Acute mental illness or substance abuse
Use of bone growth stimulator within past 30 days
Participation in other investigational device or drug clinical trials within 30 days of surgery
Prisoners

About this study

Official title: A Prospective Randomized Clinical Investigation of the SECURE-C Cervical Artificial Disc: A Pivotal Study/ SECURE-C Cervical Artificial Disc Postmarket Approval Study

The purpose of the Postmarket Approval Study is to evaluate the long-term safety and efficacy associated with the use of the SECURE-C Cervical Artificial Disc

Read the detailed description

Ages Eligible for Study: 18 to 60 years

Genders Eligible for Study: Both

Accepts Healthy Volunteers: No

Conditions: Symptomatic Cervical Disc Disease
Being tested: SECURE-C Cervical Artificial Disc, ASSURE Cervical plate and an allograft interbody spacer
Keywords: Neck Pain, Arm Pain
Medical subject headings: Neck Pain

What participants receive

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

SECURE-C Cervical Artificial DiscDevice
Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
ASSURE Cervical plate and an allograft interbody spacerDevice
Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion

Study groups in NCT00882661
Study group	Role	What they receive
SECURE-C Cervical Artificial Disc	Experimental	Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc Receives: Device: SECURE-C Cervical Artificial Disc
ASSURE Cervical plate and an allograft interbody spacer	Active comparator	Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion Receives: Device: ASSURE Cervical plate and an allograft interbody spacer

What is being measured

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

Individual Patient Overall Success
Individual patient overall success defined as pain/disability improvement of at least 25% in Neck Disability Index (NDI) compared to baseline; no device failures requiring revision, removal, reoperation, or supplemental fixation; absence of major complications defined as major vessel injury, neurological damage, or nerve injury; and for control fusion patients only, radiographic fusion
Measured: 24 months

Secondary outcomes (7)

Neck Disability Index (NDI)
Neck Disability Index (NDI) success defined as ≥25% improvement at 24 months from baseline
Measured: 24 months
Neck Pain Visual Analog Scale (VAS)
Improvement of 20mm from baseline in neck pain measured using the Visual Analog Scale (VAS)
Measured: 24 months
Left Arm Pain Visual Analog Scale (VAS)
Improvement of 20mm from baseline in left arm pain measured using the Visual Analog Scale (VAS)
Measured: 24 months
Right Arm Pain Visual Analog Scale (VAS)
Improvement of 20mm from baseline in right arm pain measured using the Visual Analog Scale (VAS)
Measured: 24 months
SF-36 PCS
Health Status Survey SF-36 physical composite scores: 15% improvement from baseline
Measured: 24 months
SF-36 MCS
Health Status Survey SF-36 mental composite scores: 15% improvement from baseline
Measured: 24 months
Satisfaction
Patient satisfaction (definitely/mostly): proportion of patients
Measured: 24 months

Timeline

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

Jul 2005Feb 2017

First posted16 Apr 2009 (estimated)
Study startJul 2005
Primary completionApr 2010
Study completionFeb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Symptomatic Cervical Disc DiseaseStudies of the same condition, open and under way.
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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 380 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00882661
Sponsor's protocol ID: GPR002
Status last verified: Jun 2017
First submitted: 14 Apr 2009
Last updated: 9 Jun 2017
Results posted: Yes, on ClinicalTrials.gov

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?

Official record

Active, not recruiting
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
Cervical Degenerative Disc Disease
Enrolling by invitationObservational study
Retrospective Analysis of Patients Implanted With 2 Levels of Prodisc® C Vivo Devices
Degenerative Disc Disease, Cervical Spine Degenerative Disease
Not yet recruiting
A Multi-Center, Prospective Historically Controlled Clinical Trial Comparing the Safety and Effectiveness of Triadyme-C to a Total Disc Replacement Control Cohort in the Treatment of Symptomatic Cervical Disc Disease (SCDD) at a Single Level
Cervical Disc Disease
Active, not recruiting
The Synergy Disc To Anterior Cervical Discectomy and Fusion
Cervical Degenerative Disc Disease
Active, not recruiting
2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C
Symptomatic Cervical Disc Disease

All Symptomatic Cervical Disc Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Randomized Clinical Investigation of the SECURE-C Cervical Artificial Disc: A Pivotal Study/ SECURE-C Cervical Artificial Disc Postmarket Approval Study
ClinicalTrials.gov ID: NCT00882661
Acronym / sponsor ID: GPR002
Conditions: Symptomatic Cervical Disc Disease
Keywords: Neck Pain, Arm Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 380 participants (actual)
Lead sponsor: Globus Medical IncIndustry (pharma, biotech, devices)
Study start: Jul 2005
Primary completion: Apr 2010 (actual)
Study completion: Feb 2017 (actual)
First posted: 16 Apr 2009 (estimated)
Results: Posted 9 Jun 2017

Clinical summary

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

The purpose of the Postmarket Approval Study is to evaluate the long-term safety and efficacy associated with the use of the SECURE-C Cervical Artificial Disc

Detailed description

Ages Eligible for Study: 18 to 60 years

Genders Eligible for Study: Both

Accepts Healthy Volunteers: No

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
SECURE-C Cervical Artificial Disc	Experimental	Device: SECURE-C Cervical Artificial DiscTreatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
ASSURE Cervical plate and an allograft interbody spacer	Active comparator	Device: ASSURE Cervical plate and an allograft interbody spacerTreatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Symptomatic cervical disc disease (SCDD) in one vertebral level between C3-C7, defined as neck or arm (radicular) pain, or functional or neurological deficit and radiographic confirmation (by CT, MRI, X-ray, etc.) of any of the following:
Herniated nucleus pulposus;
Radiculopathy or myelopathy;
Spondylosis (defined by the presence of osteophytes); or
Loss of disc height.

Key exclusion criteria (26 listed)

More than one vertebral level requiring treatment
Prior fusion surgery adjacent to the vertebral level being treated
Prior surgery at the level to be treated
Clinically compromised vertebral bodies at the affected level(s) due to current or past trauma
Radiographic confirmation of facet joint disease or degeneration, defined as apparent sclerosis and/or hypertrophy of the facets demonstrated on AP radiographs as a disruption of the normally smooth facet curve

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
SECURE-C Cervical Artificial DiscTreatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc	Device	SECURE-C Cervical Artificial Disc
ASSURE Cervical plate and an allograft interbody spacerTreatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion	Device	ASSURE Cervical plate and an allograft interbody spacer

Primary outcome

Individual Patient Overall Success
Time frame: 24 months
Individual patient overall success defined as pain/disability improvement of at least 25% in Neck Disability Index (NDI) compared to baseline; no device failures requiring revision, removal, reoperation, or supplemental fixation; absence of major complications defined as major vessel injury, neurological damage, or nerve injury; and for control fusion patients only, radiographic fusion

7 secondary outcomes

Neck Disability Index (NDI)
Time frame: 24 months
Neck Pain Visual Analog Scale (VAS)
Time frame: 24 months
Left Arm Pain Visual Analog Scale (VAS)
Time frame: 24 months
Right Arm Pain Visual Analog Scale (VAS)
Time frame: 24 months
SF-36 PCS
Time frame: 24 months
SF-36 MCS
Time frame: 24 months
Satisfaction
Time frame: 24 months

Results and safety

Results posted to the registry on 9 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SECURE-C Cervical Artificial Disc	89	79
ASSURE Cervical Plate and an Allograft Interbody Spacer	0	0

Primary outcome: Individual Patient Overall Success

Time frame: 24 months. Number. Unit: participants

Measure	Randomized SECURE-C Cervical Artificial Disc n = 141	ASSURE Cervical Plate and an Allograft Interbody Spacer n = 114	Non-Randomized SECURE-C Cervical Artificial Disc n = 79
Value	127	81	67

Population analysed: At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete primary endpoint data was available for 79 Non-randomized SECURE-C patients,141 randomized SECURE-C patients and 114 control patients at 24 months.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 months. Other adverse events reported at .5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SECURE-C Cervical Artificial Disc	46 of 236 (19.5%)	121 of 236 (51.3%)	Not reported
ASSURE Cervical Plate and an Allograft Interbody Spacer	34 of 144 (23.6%)	80 of 144 (55.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Symptomatic Cervical Disc Disease

Active, not recruiting
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
Cervical Degenerative Disc Disease
Enrolling by invitationObservational study
Retrospective Analysis of Patients Implanted With 2 Levels of Prodisc® C Vivo Devices
Degenerative Disc Disease, Cervical Spine Degenerative Disease
Not yet recruiting
A Multi-Center, Prospective Historically Controlled Clinical Trial Comparing the Safety and Effectiveness of Triadyme-C to a Total Disc Replacement Control Cohort in the Treatment of Symptomatic Cervical Disc Disease (SCDD) at a Single Level
Cervical Disc Disease
Active, not recruiting
The Synergy Disc To Anterior Cervical Discectomy and Fusion
Cervical Degenerative Disc Disease
Active, not recruiting
2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C
Symptomatic Cervical Disc Disease

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.

Joseph M Marzluff, MD principal investigator

Trident Regional Medical Center

Questions about this trial

What is this clinical trial studying?

A study testing SECURE-C Cervical Artificial Disc and ASSURE Cervical plate and an allograft interbody spacer in people with Symptomatic Cervical Disc Disease, run by Globus Medical Inc.

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 12 inclusion and 26 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 9 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Individual Patient Overall Success (time frame: 24 months). 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 NCT00882661.

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 9 Jun 2017.