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

February 12, 2014 updated by: Orthofix Inc.

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Advent™ Cervical Disc
Cervical artificial disc replacement: Advent™ Cervical Disc
Device: Cervical Artificial Disc (Advent™ Cervical Disc)
Advent™ Cervical Disc
Other Names:
  • 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of Device and/or Procedure Related Adverse Event(s)
Time Frame: At 24-months
At 24-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orthofix Inc.

Investigators

  • Study Director: Scott L Blumenthal, M.D., Texas Back Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

March 10, 2008

First Submitted That Met QC Criteria

March 14, 2008

First Posted (Estimate)

March 17, 2008

Study Record Updates

Last Update Posted (Estimate)

March 27, 2014

Last Update Submitted That Met QC Criteria

February 12, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-01003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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