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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00437190
Recruitment Status : Completed
First Posted : February 19, 2007
Last Update Posted : May 13, 2016
Information provided by (Responsible Party):
Medtronic Spinal and Biologics

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Radiculopathy Myelopathy Cervical Degenerative Disc Disease Device: ATLANTIS™ Cervical Plate System and allograft Device: BRYAN Cervical Disc Prosthesis Not Applicable

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  (Clinical Trial)
Actual Enrollment : 494 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of Degenerative Disc Disease
Study Start Date : June 2003
Actual Primary Completion Date : December 2006
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00437190

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Sponsors and Collaborators
Medtronic Spinal and Biologics
Principal Investigator: Rick C Sasso, MD Indiana Spine Group

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Medtronic Spinal and Biologics Identifier: NCT00437190     History of Changes
Other Study ID Numbers: BRYAN(R) Cervical Disc IDE
First Posted: February 19, 2007    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016

Keywords provided by Medtronic Spinal and Biologics:
Cervical Disc Replacement
Spondylotic radiculopathy
Spondylotic myelopathy

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spinal Cord Diseases
Bone Marrow Diseases
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Central Nervous System Diseases
Hematologic Diseases