Post-Market Study Evaluating the Safety and Effectiveness of NuNec® Cervical Arthroplasty System (NCT01832818) | Clinical Trial Compass
TerminatedNot Applicable
Post-Market Study Evaluating the Safety and Effectiveness of NuNec® Cervical Arthroplasty System
Stopped: This study has been terminated early due to slow enrolment.
United Kingdom14 participantsStarted 2012-03
Plain-language summary
The objective of this study is to evaluate long-term safety and effectiveness of the NuNec® Cervical Arthroplasty System in a small patient population. The NuNec device is currently CE marked and commercially available in Europe.
Who can participate
Age range
21 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:
* is at least 21 years of age and skeletally mature
* must have symptomatic degenerative disc disease at one level in the cervical spine, C3 to C7, demonstrated by herniated disc and/or spondylosis;
* must have completed a minimum of six weeks of unsuccessful conservative, non-operative care or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of conservative treatment
* must score at least 15/50 (30%) on the Neck Disability Index
* is willing and able to follow the post-operative management program
* must understand and sign the informed consent document
Exclusion Criteria:
* symptomatic cervical DDD at more than one level
* axial neck pain as the primary diagnosis without evidence of neural compression
* neck or arm pain of unknown etiology
* any significant anatomical consideration which would make the anterior cervical approach excessively risky or impossible
* severe spondylosis at the target level
* prior surgery at the target level
* fused level adjacent to the target level
* osteoporosis, osteopenia, osteomalacia, Paget's disease or metabolic bone disease
* active infection or surgical site infection
* is using any medication known to interfere with bone/soft tissue healing
* diabetes mellitus requiring daily insulin management
* any terminal, systemic, or autoimmune disease
* medical conditions or mental incompetence which may interfere with study requirements
* BMI \>40 or a weight more than 10…
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
1
Neck Disability Index (NDI) Score Improvement of at Least 15 Points
Timeframe: At 24 months
2
Visual Analog Scale (VAS) Improvement of 2.0 cm for Neck Pain
Timeframe: At 24 months
3
Serious Adverse Events Related to the Device
Timeframe: Up to 24 months
4
Device Failures or Removals, Revisions, Re-operations