Status:
TERMINATED
Post-Market Study Evaluating the Safety and Effectiveness of NuNec® Cervical Arthroplasty System
Lead Sponsor:
Pioneer Surgical Technology, Inc.
Conditions:
Cervical Intervertebral Disc Degeneration
Eligibility:
All Genders
21+ years
Phase:
NA
Brief 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 comm...
Detailed Description
The NuNec® feasibility study is a prospective, multi-centered, non-randomized clinical trial. Only patients who have been diagnosed with single level, C3 to C7, symptomatic cervical degenerative disc ...
Eligibility Criteria
Inclusion
- 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
- 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 100 lbs over ideal body weight
- chemical dependency problem that may interfere with study requirements
- current smokers
- history of any invasive malignancy unless treated and in remission for at least two years
- documented allergies to metal or plastic
- currently pregnant, or interested in becoming pregnant during the study follow-up
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01832818
Start Date
March 1 2012
End Date
January 1 2016
Last Update
February 15 2019
Active Locations (1)
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1
University Hospital of North Tees
Stockton-on-Tees, United Kingdom