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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7.
University Hospital of North Tees
Stockton-on-Tees, United Kingdom
Neck Disability Index (NDI) Score Improvement of at Least 15 Points
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.
Time frame: At 24 months
Visual Analog Scale (VAS) Improvement of 2.0 cm for Neck Pain
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.
Time frame: At 24 months
Serious Adverse Events Related to the Device
The number of serious adverse events have been recorded
Time frame: Up to 24 months
Device Failures or Removals, Revisions, Re-operations
The failures or re-operations or supplemental fixation at the treated level
Time frame: Up to 24 months
Patient Satisfaction
As assessed on patient questionnaire.
Time frame: At 24 months
Absence of Device Migration or Subsidence
Absence of device migration \> 3mm; Absence of device subsidence \> 3mm
Time frame: Up to 24 months
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