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

Not Applicable

Completed

Conditions: Symptomatic Cervical Disc Disease

Interventions: Device: ASSURE Cervical plate and an allograft interbody spacer
Device: SECURE-C Cervical Artificial Disc

Registration Number: NCT00882661

Lead Sponsor: Globus Medical Inc

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 380

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASSURE Cervical plate and an allograft interbody spacer	ASSURE Cervical plate and an allograft interbody spacer	Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
SECURE-C Cervical Artificial Disc	SECURE-C Cervical Artificial Disc	Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc

Primary Outcome Measures

Name	Time	Method
Individual Patient Overall Success	24 months	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

Secondary Outcome Measures

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