CompletedNot Applicable

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

380 participantsStarted 2005-07

Plain-language 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. 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

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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/extensio…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Individual Patient Overall Success

Timeframe: 24 months

Trial details

NCT IDNCT00882661

SponsorGlobus Medical Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-04

Results submitted2014-08-21

View on ClinicalTrials.gov More Symptomatic Cervical Disc Disease trials