Clinical trial NCT00882661: SECURE®-C Cervical Artificial Disc Clinical Study/ SECURE-C Cervical Artificial Disc Postmarket Approval Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Symptomatic Cervical Disc Disease
Keywords: Neck Pain
Arm Pain
Lead sponsor: Globus Medical Inc
Sponsor class: INDUSTRY
First posted: 2009-04-16
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Individual Patient Overall Success
timeFrame: 24 months
Secondary outcomes:
measure: Neck Disability Index (NDI)
timeFrame: 24 months
measure: Neck Pain Visual Analog Scale (VAS)
timeFrame: 24 months
measure: Left Arm Pain Visual Analog Scale (VAS)
timeFrame: 24 months
measure: Right Arm Pain Visual Analog Scale (VAS)
timeFrame: 24 months
measure: SF-36 PCS
timeFrame: 24 months
measure: SF-36 MCS
timeFrame: 24 months
measure: Satisfaction
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Trident Regional Medical Center
name: Joseph M Marzluff, MD
role: PRINCIPAL_INVESTIGATOR
References: