SECURE®-C Cervical Artificial Disc Clinical Study/ SECURE-C Cervical Artificial Disc Postmarket Approval Study

Study Overview
=================
Brief Summary
-----------------
The purpose of the pivotal IDE clinical study was to evaluate the safety and effectiveness of the SECURE®-C Cervical Artificial Disc for the treatment of symptomatic cervical disc disease at one level between C3 and C7, compared to anterior cervical discectomy and fusion. The purpose of the Postmarket Approval Study is to evaluate the long-term safety and efficacy associated with the use of the SECURE-C Cervical Artificial Disc

Detailed Description
-----------------
Ages Eligible for Study: 18 to 60 years Genders Eligible for Study: Both Accepts Healthy Volunteers: No

Official Title
-----------------
A Prospective Randomized Clinical Investigation of the SECURE-C Cervical Artificial Disc: A Pivotal Study/ SECURE-C Cervical Artificial Disc Postmarket Approval Study

Conditions
-----------------
Symptomatic Cervical Disc Disease

Intervention / Treatment
-----------------
* Device: SECURE-C Cervical Artificial Disc
* Device: ASSURE Cervical plate and an allograft interbody spacer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic cervical disc disease (SCDD) in one vertebral level between C3-C7, defined as neck or arm (radicular) pain, or functional or neurological deficit and radiographic confirmation (by CT, MRI, X-ray, etc.) of any of the following: Herniated nucleus pulposus; Radiculopathy or myelopathy; Spondylosis (defined by the presence of osteophytes); or Loss of disc height. Age between 18 and 60 years Failed at least 6 weeks of conservative treatment Neck Disability Index (NDI) Questionnaire score of at least 30 (as percentage of 50 point total) Able to understand and sign informed consent form Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and filling out forms Able to meet the proposed follow-up schedule at 6 weeks, 3 months, 6 months, 12 months and 24 months Able to follow postoperative management program Exclusion Criteria: More than one vertebral level requiring treatment Prior fusion surgery adjacent to the vertebral level being treated Prior surgery at the level to be treated Clinically compromised vertebral bodies at the affected level(s) due to current or past trauma Radiographic confirmation of facet joint disease or degeneration, defined as apparent sclerosis and/or hypertrophy of the facets demonstrated on AP radiographs as a disruption of the normally smooth facet curve Marked cervical instability on resting lateral or flexion/extension radiographs: Translation greater than 3mm, and/or More than 11° of rotational difference from that of either adjacent level. Severe spondylosis at the level to be treated as characterized by any of the following: Bridging osteophytes; A loss of disc height greater than 50%; or Absence of motion (<2°) Neck or arm pain of unknown etiology Osteoporosis, osteopenia, Paget's disease, osteomalacia or any other metabolic bone disease Pregnant or interested in becoming pregnant in the next 2 years Active systemic or local infection Known allergy to titanium, polyethylene, cobalt, chromium or molybdenum Taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids) Rheumatoid arthritis or other autoimmune disease Systemic disease including AIDS, HIV, Hepatitis Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there has been no clinical signs or symptoms of the malignancy for at least 5 years Neuromuscular disorders such as muscular dystrophy, spinal muscular atrophy, amyotrophic lateral sclerosis, etc. Acute mental illness or substance abuse Use of bone growth stimulator within past 30 days Participation in other investigational device or drug clinical trials within 30 days of surgery Prisoners

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SECURE-C Cervical Artificial Disc<br>Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc | Device: SECURE-C Cervical Artificial Disc<br>* Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc<br>|
| Active Comparator: ASSURE Cervical plate and an allograft interbody spacer<br>Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion | Device: ASSURE Cervical plate and an allograft interbody spacer<br>* Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual Patient Overall Success | Individual patient overall success defined as pain/disability improvement of at least 25% in Neck Disability Index (NDI) compared to baseline; no device failures requiring revision, removal, reoperation, or supplemental fixation; absence of major complications defined as major vessel injury, neurological damage, or nerve injury; and for control fusion patients only, radiographic fusion | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck Disability Index (NDI) | Neck Disability Index (NDI) success defined as ≥25% improvement at 24 months from baseline | 24 months | 
| Neck Pain Visual Analog Scale (VAS) | Improvement of 20mm from baseline in neck pain measured using the Visual Analog Scale (VAS) | 24 months | 
| Left Arm Pain Visual Analog Scale (VAS) | Improvement of 20mm from baseline in left arm pain measured using the Visual Analog Scale (VAS) | 24 months | 
| Right Arm Pain Visual Analog Scale (VAS) | Improvement of 20mm from baseline in right arm pain measured using the Visual Analog Scale (VAS) | 24 months | 
| SF-36 PCS | Health Status Survey SF-36 physical composite scores: 15% improvement from baseline | 24 months | 
| SF-36 MCS | Health Status Survey SF-36 mental composite scores: 15% improvement from baseline | 24 months | 
| Satisfaction | Patient satisfaction (definitely/mostly): proportion of patients | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neck Pain, Arm Pain