March 10, 2008 |
July 31, 2009 |
March 2008 |
- Evaluation of device and/or procedure related adverse event(s) [ Time Frame: At 24-months ] [ Designated as safety issue: Yes ]
- Maintenance or improvement neurological status [ Time Frame: At 24-months ] [ Designated as safety issue: Yes ]
- Improvement in Neck Disability Index [ Time Frame: At 24 months ] [ Designated as safety issue: No ]
- Quantitative radiographic assessment of range of motion (ROM) and qualitative radiographic fusion assessment [ Time Frame: At 24-months ] [ Designated as safety issue: No ]
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Same as current |
Complete list of historical versions of study NCT00637312 on ClinicalTrials.gov Archive Site |
- Arm and neck pain as measured by Visual Analogue Scales (VAS) [ Time Frame: At 24-months ] [ Designated as safety issue: No ]
- Odom's criteria score [ Time Frame: At 24-months ] [ Designated as safety issue: No ]
- Nurick's Classification [ Time Frame: At 24-months ] [ Designated as safety issue: No ]
- Overall Quality of Life (SF-36v2™) [ Time Frame: At 24-months ] [ Designated as safety issue: No ]
- Disc height maintenance [ Time Frame: At 24-months ] [ Designated as safety issue: No ]
- Pain medication use [ Time Frame: At 24-months ] [ Designated as safety issue: No ]
- Post-operative time to normal activity [ Time Frame: At 24 months ] [ Designated as safety issue: No ]
- Self-reported satisfaction with treatment [ Time Frame: At 24 months ] [ Designated as safety issue: No ]
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Same as current |
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Advent™ Cervical Disc Versus Anterior Cervical Discectomy and Fusion(ACDF) for Treatment of One Level Degenerative Disc Disease (IDE Study) |
Clinical Trial Comparing the Blackstone Advent™ Cervical Disc to Anterior Cervical Discectomy and Fusion (ACDF) for the Treatment of One Level Degenerative Disc Disease |
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 a single-level in the cervical spine (from C3 to C7) following cervical discectomy in skeletally mature patients (at least 18 years of age). |
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 enrolled completes their 24 Month follow-up |
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Interventional |
Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study |
Cervical Degenerative Disc Disease |
- Device: Cervical Artificial Disc (Advent™ Cervical Disc)
- Device: ACDF (Hallmark™ Anterior Cervical Plate System with corticocancellous allograft bone)
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- Experimental: Advent™ Cervical Disc
- Active Comparator: ACDF Control
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Suspended |
450 |
March 2012 |
March 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- 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 Criteria:
- 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).
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Both |
18 Years and older |
No |
Contact information is only displayed when the study is recruiting subjects |
United States |
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NCT00637312 |
Andrew Tummon, Blackstone Medical Inc |
CP-01003 |
Orthofix, Inc. |
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Study Director: |
Scott L Blumenthal, M.D. |
Texas Back Institute |
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Orthofix, Inc. |
July 2009 |