Post-Market Study Evaluating the Safety and Effectiveness of NuNec® Cervical Arthroplasty System

Not Applicable

Terminated

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 commercially available in Europe.

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 disease and have failed at least 6 weeks of conservative treatment or present signs of progression of spinal cord/nerve root compression with continued non-operative care will be enrolled.

Patients will be evaluated preoperatively and postoperatively at discharge, 6 weeks, 3, 6, 12 and 24 months.

Recruitment & Eligibility

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 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

Arm && Interventions

Group	Intervention	Description
NuNec Cervical Disc	NuNec Cervical Disc	Each patient will be implanted with the NuNec Cervical Disc in a single level from C3 to C7. Postoperatively, patient evaluated at discharge, 6 weeks, 3, 6, 12 and 24 months.

Primary Outcome Measures

Name	Time	Method
Neck Disability Index (NDI) Score Improvement of at Least 15 Points	At 24 months	The Neck Disability Index is a patient reported outcome measure for self-rated disability due to neck pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score. A higher score would indicate that the patient did not improve.
Visual Analog Scale (VAS) Improvement of 2.0 cm for Neck Pain	At 24 months	The pain Visual Analog Scale is a uni-dimensional measure of pain intensity, represented by a 100 mm line, anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \[100-mm scale\]). A higher score would indicate that the patient had a worse outcome.
Serious Adverse Events Related to the Device	Up to 24 months	The number of serious adverse events have been recorded
Device Failures or Removals, Revisions, Re-operations	Up to 24 months	The failures or re-operations or supplemental fixation at the treated level

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction	At 24 months	As assessed on patient questionnaire.
Absence of Device Migration or Subsidence	Up to 24 months	Absence of device migration \> 3mm; Absence of device subsidence \> 3mm