Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of DDD Versus ACDF

May 11, 2016 updated by: Medtronic Spinal and Biologics

Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of Degenerative Disc Disease

The purpose of this study is to establish the safety and effectiveness of the BRYAN(R) Cervical Disc Prosthesis in treating single-level degenerative disc disease of the cervical spine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Bryan(R) Cervical Disc Prosthesis is indicated in skeletally mature patients for reconstruction of the disc from C3 to C7 following single level discectomy for intractable radiculopathy and/or myelopathy.

Study Type

Interventional

Enrollment (Actual)

494

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
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurosurgical Associates
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Campbell, California, United States, 95008
        • Silicon Valley Spine Institute
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
      • Newport Beach, California, United States, 92663
        • Hoag Memorial Hospital
      • Walnut Creek, California, United States, 94598
        • Bay Area Spine Institute
    • Florida
      • Gainesville, Florida, United States, 32605
        • North Florida Regional Medical Center
      • Miami, Florida, United States, 33136
        • University of Miami School of Medicine
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Neurological Clinic
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Emory Orthopedics and Spine Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Department of Neurosurgery
      • Chicago, Illinois, United States, 60637
        • University of Chicago Hospitals Section of Neurosurgery
      • Chicago, Illinois, United States, 60640
        • Chicago Inst. of Neurosurgery and Neuro Research
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine
      • Indianapolis, Indiana, United States, 46260
        • Indiana Spine Group
    • Maine
      • Scarborough, Maine, United States, 04074
        • Neurosurgery Associates
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Maryland Brain & Spine
    • Michigan
      • Kalamazoo, Michigan, United States, 49048
        • Neurosurgery of Kalamazoo
      • Marquette, Michigan, United States, 49855
        • Marquette General Brain & Spine Center
    • Minnesota
      • Edina, Minnesota, United States, 55439
        • Cervical Spine Specialists
      • Minneapolis, Minnesota, United States, 55404
        • Twin Cities Spine Center
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Columbia Orthopaedic Group
      • St. Louis, Missouri, United States, 63110
        • Washington University Orthopedics
    • Nevada
      • Reno, Nevada, United States, 89502
        • Spine Nevada
    • New York
      • Rochester, New York, United States, 14623
        • Rochester Brain and Spine Neuro
      • Syracuse, New York, United States, 13210
        • Crouse Hospital
      • Syracuse, New York, United States, 13029
        • Upstate Orthopedics
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Carolina Neurosurgery and Spine Specialists
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University School of Medicine - Dept. of Neurosurgery Medical Center
    • Ohio
      • Toledo, Ohio, United States, 43608
        • Neurosurgical Network, Inc.
    • Oregon
      • Portland, Oregon, United States, 97086
        • Kellogg MD Brain & Spine
      • Springfield, Oregon, United States, 97477
        • Oregon Neurosurgery
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Southeastern Spine Institute
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Neurosurgical Associates
    • Texas
      • Plano, Texas, United States, 75093
        • NeuroSpine Consultants, PA
    • Utah
      • Salt Lake City, Utah, United States, 84103
        • Neurosurgery Associates
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Medical School

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

The indication studied was degenerative disc disease (DDD) at a single level between C3 and C7 for any combination of disc herniation with radiculopathy, spondylotic radiculopathy, disc herniation with myelopathy, or spondylotic myelopathy.

The following additional inclusion criteria had to be present:

  • At least 6 weeks unsuccessful conservative treatment, except in cases of myelopathy requiring immediate treatment (e.g., acute onset of clinically significant signs);
  • Requirement for surgical treatment demonstrated by CT, myelography and CT, and/or MRI;
  • Skeletally mature (≥ 21 years of age);
  • Preoperative Neck Disability Index score of ≥ 30 and at least one clinical sign associated with level to be treated;
  • Willing to sign informed consent and comply with protocol.

Exclusion Criteria:

Subjects were excluded if they had any of the following:

  • Any of the following at the treated level:

    • Significant cervical anatomical deformity; e.g., ankylosing spondylitis, rheumatoid arthritis, etc.
    • Moderate to advanced spondylosis. Patients who demonstrate advanced degenerative changes. Such advanced changes are characterized by any one or combination of the following: bridging osteophytes, marked reduction or absence of motion, collapse of the intervertebral disc space of greater than 50% of its normal height;
    • Radiographic signs of subluxation greater than 3.5 mm;
    • Angulation of the disc space more than 11 degrees greater than adjacent segments;
    • Significant kyphotic deformity or significant reversal of lordosis;
  • Axial neck pain as the solitary symptom;
  • Previous cervical spine surgery;
  • Metabolic bone disease, such as osteoporosis, defined as a BMD T-score equal to or worse than 2.5. If significant radiolucence is detected, a BMD scan in the spine, wrist, and femoral neck must be obtained.
  • Active systemic infection or infection at the operative site;
  • Known allergy or to titanium, polyurethane, or ethylene oxide residuals;
  • Concomitant conditions requiring steroid treatment;
  • Diabetes mellitus requiring daily insulin management;
  • Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index;
  • A medical condition that may interfere with the postoperative management program, such as advanced emphysema or Alzheimer's disease;
  • A medical condition that may result in patient death prior to study completion: unstable cardiac disease, active malignancy;
  • Pregnant;
  • Current or recent alcohol and/or drug abuser requiring intervention;
  • Signs of being geographically unstable, such as recent or pending divorce, or high level of job dissatisfaction.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Anterior Cervical Discectomy Fusion
Device: ATLANTIS™ Cervical Plate System and allograft
Control treatment is commercially available allograft (without bone matrix paste) used in conjunction with the Medtronic Safamor Danek ATLANTIS™ Cervical Plate System.
Other Names:
  • cervical plate
  • plate
  • fusion
  • cervical fusion
Experimental: BRYAN Cervical Disc Prosthesis
BRYAN Cervical Disc Prosthesis is a cervical intervertebral disc prosthesis designed to provide for motion like the normal cervical functional spinal unit.
Device: BRYAN Cervical Disc Prosthesis
The intent is to treat stable degenerative disc disease by implanting the BRYAN Cervical Disc Prosthesis to provide motion like the normal cervical functional spinal unit.
Other Names:
  • disc
  • cervical disc
  • artificial disc
  • BRYAN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in patient pain and ability to function
Time Frame: 24 months
The self-administered Neck Disability Index patient questionnaire is used to assess patient pain and ability to function. A successful outcome will be declared if: Postoperative Score - Postoperative Score is ≥ 15.
24 months

Collaborators and Investigators

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

Sponsor

Medtronic Spinal and Biologics

Investigators

  • Principal Investigator: Rick C Sasso, MD, Indiana Spine Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2003

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

February 16, 2007

First Submitted That Met QC Criteria

February 16, 2007

First Posted (Estimate)

February 19, 2007

Study Record Updates

Last Update Posted (Estimate)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRYAN(R) Cervical Disc IDE

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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