Advent™ Cervical Disc Versus ACDF for Treatment of One Level Degenerative Disc Disease (IDE Study)

This study has been terminated.
(Greater-than-anticipated rate of revisions)
Sponsor:
Information provided by (Responsible Party):
Orthofix Inc.
ClinicalTrials.gov Identifier:
NCT00637312
First received: March 10, 2008
Last updated: February 12, 2014
Last verified: February 2014
  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: Hallmark™ Anterior Cervical Plate System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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 ]

Enrollment: 108
Study Start Date: March 2008
Study Completion Date: February 2013
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Advent™ Cervical Disc
Cervical artificial disc replacement: Advent™ Cervical Disc
Device: Cervical Artificial Disc (Advent™ Cervical Disc)
Advent™ Cervical Disc
Other Name: Advent™ Cervical Disc
Active Comparator: Standard care - Control
Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System
Device: Hallmark™ Anterior Cervical Plate System
Hallmark™ Anterior Cervical Plate System with AlloQuent Structural Allograft (corticocancellous allograft bone)
Other Name: Hallmark™ Anterior Cervical Plate System

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637312

Locations
United States, California
University of California Davis
Sacramento, California, United States, 95816
United States, Colorado
Boulder Neurosurgical Associates
Boulder, Colorado, United States, 80304
United States, Florida
University of South Florida
Tampa, Florida, United States, 33606
United States, Louisiana
Spine Institute of Louisiana
Shreveport, Louisiana, United States, 71101
United States, Maryland
Brain and Spine Specialist
Baltimore, Maryland, United States, 21215
United States, New Jersey
Cooper University Neurological Institute
Camden, New Jersey, United States, 08103
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Triangle Orthopaedics Associates, P.A.
Durham, North Carolina, United States, 27704
United States, Pennsylvania
University of Pennsylvania, Department of Neurosurgery
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
East Tennessee Brain and Spine Center
Johnson City, Tennessee, United States, 37604
United States, Texas
Texas Back Institute
Plano, Texas, United States, 75093
The San Antonio Orthopaedic Group
San Antonio, Texas, United States, 78216
Sponsors and Collaborators
Orthofix Inc.
Investigators
Study Director: Scott L Blumenthal, M.D. Texas Back Institute
  More Information

No publications provided

Responsible Party: Orthofix Inc.
ClinicalTrials.gov Identifier: NCT00637312     History of Changes
Other Study ID Numbers: CP-01003
Study First Received: March 10, 2008
Results First Received: February 12, 2014
Last Updated: February 12, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Spinal Diseases
Intervertebral Disk Degeneration
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 20, 2014