Post-Market Study Evaluating the Safety and Effectiveness of NuNecĀ® Cervical Arthroplasty System (NCT01832818) | Clinical Trial Compass
TerminatedNot Applicable
Post-Market Study Evaluating the Safety and Effectiveness of NuNecĀ® 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 NuNecĀ® Cervical Arthroplasty System in a small patient population. The NuNec device is currently CE marked and commercially available in Europe.
Who can participate
Age range21 Years
SexALL
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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 10ā¦
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