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

Symptomatic Cervical Disc Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00882661
• Other study ID #: GPR002
• Status: Completed
• Phase: N/A
• First received: April 14, 2009
• Last updated: June 7, 2017
• Start date: July 2005
• Est. completion date: February 2017

Study information

• Verified date: June 2017
• Source: Globus Medical Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Ages Eligible for Study: 18 to 60 years

Genders Eligible for Study: Both

Accepts Healthy Volunteers: No

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: February 2017
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Symptomatic Cervical Disc Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Globus Medical Inc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Neck Disability Index (NDI)	Neck Disability Index (NDI) success defined as =25% improvement at 24 months from baseline	24 months
Secondary	Neck Pain Visual Analog Scale (VAS)	Improvement of 20mm from baseline in neck pain measured using the Visual Analog Scale (VAS)	24 months
Secondary	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
Secondary	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
Secondary	SF-36 PCS	Health Status Survey SF-36 physical composite scores: 15% improvement from baseline	24 months
Secondary	SF-36 MCS	Health Status Survey SF-36 mental composite scores: 15% improvement from baseline	24 months
Secondary	Satisfaction	Patient satisfaction (definitely/mostly): proportion of patients	24 months