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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier:
NCT00437190
First received: February 16, 2007
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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 Intervention
Radiculopathy
Myelopathy
Cervical Degenerative Disc Disease
Device: ATLANTIS™ Cervical Plate System and allograft
Device: BRYAN Cervical Disc Prosthesis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of Degenerative Disc Disease

Resource links provided by NLM:


Further study details as provided by Medtronic Spinal and Biologics:

Primary Outcome Measures:
  • Improvement in patient pain and ability to function [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 494
Study Start Date: June 2003
Estimated Study Completion Date: April 2016
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00437190

  Show 38 Study Locations
Sponsors and Collaborators
Medtronic Spinal and Biologics
Investigators
Principal Investigator: Rick C Sasso, MD Indiana Spine Group
  More Information

Publications:
Responsible Party: Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier: NCT00437190     History of Changes
Other Study ID Numbers: BRYAN(R) Cervical Disc IDE
Study First Received: February 16, 2007
Last Updated: February 11, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 15, 2014