This trial is active, not recruiting.

Condition symptomatic cervical disc disease
Treatments secure-c cervical artificial disc, assure cervical plate and an allograft interbody spacer
Phase phase 3
Sponsor Globus Medical Inc
Start date July 2005
End date April 2010
Trial size 380 participants
Trial identifier NCT00882661, GPR002


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment

Primary Outcomes

Improvement in pain/disability using the Neck Disability Index (NDI)
time frame: 24 months for the IDE; 60 and 84 months for the Postmarket Approval Study

Secondary Outcomes

Improvement in neck and arm pain measured using the Visual Analog Scale (VAS), neurologic status, and health status
time frame: 24 months for the IDE; 60 and 84 months for the Postmarket Approval Study

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

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
Principal investigator Joseph M Marzluff, MD
Description Ages Eligible for Study: 18 to 60 years Genders Eligible for Study: Both Accepts Healthy Volunteers: No
Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by Globus Medical Inc.