Status:
TERMINATED
Advent™ Cervical Disc Versus ACDF for Treatment of One Level Degenerative Disc Disease (IDE Study)
Lead Sponsor:
Orthofix Inc.
Conditions:
Cervical Degenerative Disc Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to establish the safety and effectiveness of the Advent™ Cervical Disc compared to Anterior Cervical Discectomy and Fusion (ACDF) in treating degenerative disc disease at ...
Detailed Description
Following surgery study subjects will be evaluated at the following intervals: 6 wks (± 2wks); 3 Months (±2 wks); 6 Month (±1 months); 12 and 24 Month (±2 months) and annually until the last subject e...
Eligibility Criteria
Inclusion
- One cervical spine level between C3 and C7 which requires surgical treatment for intractable cervical radiculopathy and/or myelopathy demonstrated by herniated disc, and/or osteophyte formation leading to nerve root and/or spinal cord compression confirmed by patient history (e.g. neck and/or arm pain), functional and/or neurological deficit (e.g. numbness, weakness, diminished or pathologic reflexes, gait disturbances, etc.) and radiographic studies (e.g. CT, MRI, x-rays, etc.).
- Unresponsive to conservative care over a period of at least 6 weeks
- Neck Disability Index score ≥ 15/50 (30%)
- Willing and able to comply with the requirements of the protocol including follow-up requirements and to sign a study specific informed consent
Exclusion
- More than 1 level requiring surgical treatment for intractable cervical radiculopathy and/or myelopathy.
- Active local (at the proposed surgical site) or systemic infection
- Prior anterior neck surgery at any level.
- Prior posterior cervical spine surgery at the index level except posterior decompressive surgery where the posterior elements are preserved.
- Currently undergoing treatment for disease of the thoracic or lumbar spine.
- Axial neck pain as the primary diagnosis, without evidence of neural compression
- Significant cervical anatomical deformity
- Any anatomical consideration which in the investigators opinion would make the anterior cervical approach excessively risky or impossible
- Severe obesity defined as a Body Mass Index (BMI) \> 40
- Instability on AP, lateral neutral or flex/ext images: ≥2mm translation relative to the adjacent segment, and/or ≥ 11 degrees relative to adjacent segments
- Central disc height ≤ 2mm
- Advanced spondylosis (i.e. facet joints degeneration, anterior or posterior bridging of the interspace or lack of motion on the pre-operative flexion/extension x-rays)
- Severe cervical myelopathy as indicated by: Signs and/or symptoms \> 6months duration, Nurick's Classification grades IV or V, and/or Myelomalacia as evidence on a MRI
- Metabolic bone disease such as osteoporosis to a degree that spinal instrumentation is contra-indicated (Males over 55 years of age, females over 50 years of age and/or subjects that in the investigators opinion are medical indicative of osteoporosis (e.g. early menopause, steroid use, etc.) are required to have a DEXA scan; If the DEXA scan is ≤ -2.5t in the spine, the patient must be excluded)
- Allergy to any component of the device (titanium, polycarbonated polyurethane, polyethylene terephthalate, or ethylene oxide residuals)
- Chronic steroid or other medication use that may interfere with bony/soft tissue healing
- History of endocrine or metabolic disorders (e.g. Paget's disease) known to effect bone and mineral metabolism
- Autoimmune diseases e.g., ankylosing spondylitis, rheumatoid arthritis, etc.
- Insulin dependent diabetes mellitus
- Active malignancy
- Currently pregnant or considering becoming pregnant during the follow-up period
- Advanced emphysema, Alzheimer's disease or other medical conditions that would interfere with patient self-assessment of function, pain or quality of life
- Medical condition (e.g. unstable cardiac disease, end-stage cancer) that may result in patient death prior to study completion
- Chemical dependency (e.g. alcohol or narcotic addiction) problem that may interfere with study requirements
- Mental incompetence as determined by the Investigator which may effect participation in the study
- Incarcerated
- Involved in any current or pending litigation relating to a spinal condition
- Concurrently participating in any other investigational study
- Anatomy (e.g. endplate dimensions) at the index level not consistent with the dimensions of the implants available (e.g. based on pre-operative radiographic evaluations and templates in the surgical technique manual).
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00637312
Start Date
March 1 2008
End Date
February 1 2013
Last Update
March 27 2014
Active Locations (13)
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1
University of California Davis
Sacramento, California, United States, 95816
2
Boulder Neurosurgical Associates
Boulder, Colorado, United States, 80304
3
University of South Florida
Tampa, Florida, United States, 33606
4
Spine Institute of Louisiana
Shreveport, Louisiana, United States, 71101