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

NCT ID: NCT00882661

Last Updated: 2017-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 380 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2017-02-28

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

Conditions

Symptomatic Cervical Disc Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SECURE-C Cervical Artificial Disc

Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc

Group Type: EXPERIMENTAL

SECURE-C Cervical Artificial Disc

Intervention Type: DEVICE

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

Group Type: ACTIVE_COMPARATOR

ASSURE Cervical plate and an allograft interbody spacer

Intervention Type: DEVICE

Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion

Interventions

SECURE-C Cervical Artificial Disc

Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc

Intervention Type: DEVICE

ASSURE Cervical plate and an allograft interbody spacer

Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Globus Medical Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph M Marzluff, MD

Role: PRINCIPAL_INVESTIGATOR

Trident Regional Medical Center

Other Identifiers

GPR002

Identifier Type: -

Identifier Source: org_study_id