Status:
COMPLETED
SECURE®-C Cervical Artificial Disc Clinical Study/ SECURE-C Cervical Artificial Disc Postmarket Approval Study
Lead Sponsor:
Globus Medical Inc
Conditions:
Symptomatic Cervical Disc Disease
Eligibility:
All Genders
18-60 years
Phase:
NA
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...
Detailed Description
Ages Eligible for Study: 18 to 60 years Genders Eligible for Study: Both Accepts Healthy Volunteers: No
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT00882661
Start Date
July 1 2005
End Date
February 1 2017
Last Update
June 9 2017
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