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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Feasibility, Multi-Center Nonrandomized Clinical Trial Evaluating the Safety and Effectiveness of NuNec® Cervical Arthroplasty System

Conditions
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Cervical Intervertebral Disc Degeneration

Intervention / Treatment
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* Device: NuNec Cervical Disc


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NuNec Cervical Disc<br>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. | Device: NuNec Cervical Disc<br>* Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7.<br>* Other names: NuNec Cervical Arthroplasty System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | At 24 months | 
| Serious Adverse Events Related to the Device | The number of serious adverse events have been recorded | Up to 24 months | 
| Device Failures or Removals, Revisions, Re-operations | The failures or re-operations or supplemental fixation at the treated level | Up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction | As assessed on patient questionnaire. | At 24 months | 
| Absence of Device Migration or Subsidence | Absence of device migration > 3mm; Absence of device subsidence > 3mm | Up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Disc Replacement