Full Text View
Tabular View
No Study Results Posted
Related Studies
Advent™ Cervical Disc Versus Anterior Cervical Discectomy and Fusion(ACDF) for Treatment of One Level Degenerative Disc Disease (IDE Study)
This study is currently recruiting participants.
Verified by Orthofix, Inc., January 2009
First Received: March 10, 2008   Last Updated: January 23, 2009   History of Changes
Sponsored by: Orthofix, Inc.
Information provided by: Orthofix, Inc.
ClinicalTrials.gov Identifier: NCT00637312
  Purpose

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).


Condition Intervention
Cervical Degenerative Disc Disease
Device: Cervical Artificial Disc (Advent™ Cervical Disc)
Device: ACDF (Hallmark™ Anterior Cervical Plate System with corticocancellous allograft bone)

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Clinical Trial Comparing the Blackstone Advent™ Cervical Disc to Anterior Cervical Discectomy and Fusion (ACDF) for the Treatment of One Level Degenerative Disc Disease

Further study details as provided by Orthofix, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 450
Study Start Date: March 2008
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Advent™ Cervical Disc
Device: Cervical Artificial Disc (Advent™ Cervical Disc)
Advent™ Cervical Disc
2: Active Comparator
ACDF Control
Device: ACDF (Hallmark™ Anterior Cervical Plate System with corticocancellous allograft bone)
Hallmark™ Anterior Cervical Plate System with corticocancellous allograft bone

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 enrolled completes their 24 Month follow-up

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00637312

Contacts
Contact: Andrew Tummon 973-406-2872 atummon@blackstonemedical.com

Locations
United States, California
University of California Davis Recruiting
Sacramento, California, United States, 95816
Contact: Martha Robinson     916-734-3660     martha.robinson@ucdmc.ucdavis.edu    
United States, Colorado
Boulder Neurosurgical Associates Recruiting
Boulder, Colorado, United States, 80304
Contact: Sigita Burneikiene, M.D.     303-938-5700     sigitab@bnasurg.com    
United States, Florida
University of South Florida Recruiting
Tampa, Florida, United States, 33606
Contact: Deborah Scott     813-259-0616     descott@hsc.usf.edu    
United States, Louisiana
Spine Institute of Louisiana Recruiting
Shreveport, Louisiana, United States, 71101
Contact: Ajay Jawahar, M.D.     318-629-5555     Ajawahar@louisianaspine.org    
United States, Maryland
Brain and Spine Specialist Recruiting
Baltimore, Maryland, United States, 21215
Contact: Alanvin Orpia     410-601-0960     aorpia@lifebridgehealth.org    
United States, New Jersey
Cooper University Neurological Institute Recruiting
Camden, New Jersey, United States, 08103
Contact: Christine Rickette     856-342-3024     Rickette-Chris@CooperHealth.edu    
United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Jacqueline Behr     585-273-2417     Jacqueline_Behr@URMC.Rochester.edu    
United States, North Carolina
Triangle Orthopaedics Associates, P.A. Recruiting
Durham, North Carolina, United States, 27704
Contact: Lynn V Kamm     919-220-5255     lkamm@triangleortho.com    
United States, Pennsylvania
University of Pennsylvania, Department of Neurosurgery Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Marie Kerr     215-829-6720     kerrm@uphs.upenn.edu    
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Bonnie Muntz-Pope     843-792-8967     muntzpob@musc.edu    
United States, Tennessee
East Tennessee Brain and Spine Center Recruiting
Johnson City, Tennessee, United States, 37604
Contact: Susan Maye     423-232-8301     susanmaye1@yahoo.com    
United States, Texas
Texas Back Institute Recruiting
Plano, Texas, United States, 75093
Contact: Dawn Delacy     972-403-5544     ddelacy@spinemarkcro.com    
The San Antonio Orthopaedic Group Not yet recruiting
San Antonio, Texas, United States, 78216
Contact: Veronica Reyes     210-396-5319     vreyes@tsaog.com    
Sponsors and Collaborators
Orthofix, Inc.
Investigators
Study Director: Scott L Blumenthal, M.D. Texas Back Institute
  More Information

No publications provided

Responsible Party: Blackstone Medical Inc ( Andrew Tummon )
Study ID Numbers: CP-01003
Study First Received: March 10, 2008
Last Updated: January 23, 2009
ClinicalTrials.gov Identifier: NCT00637312     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Spinal Diseases
Musculoskeletal Diseases
Bone Diseases

Additional relevant MeSH terms:
Spinal Diseases
Musculoskeletal Diseases
Bone Diseases

ClinicalTrials.gov processed this record on May 07, 2009