Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of DDD Versus ACDF
- Conditions
- RadiculopathyMyelopathyCervical Degenerative Disc Disease
- Interventions
- Device: ATLANTIS™ Cervical Plate System and allograftDevice: BRYAN Cervical Disc Prosthesis
- Registration Number
- NCT00437190
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 494
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.
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Anterior Cervical Discectomy Fusion ATLANTIS™ Cervical Plate System and allograft - BRYAN Cervical Disc Prosthesis 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.
- Primary Outcome Measures
Name Time Method Improvement in patient pain and ability to function 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (37)
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
North Florida Regional Medical Center
🇺🇸Gainesville, Florida, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Silicon Valley Spine Institute
🇺🇸Campbell, California, United States
Hoag Memorial Hospital
🇺🇸Newport Beach, California, United States
Bay Area Spine Institute
🇺🇸Walnut Creek, California, United States
Tallahassee Neurological Clinic
🇺🇸Tallahassee, Florida, United States
Northwestern University Department of Neurosurgery
🇺🇸Chicago, Illinois, United States
Chicago Inst. of Neurosurgery and Neuro Research
🇺🇸Chicago, Illinois, United States
Neurosurgery of Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
Maryland Brain & Spine
🇺🇸Annapolis, Maryland, United States
Cervical Spine Specialists
🇺🇸Edina, Minnesota, United States
Columbia Orthopaedic Group
🇺🇸Columbia, Missouri, United States
Washington University Orthopedics
🇺🇸St. Louis, Missouri, United States
Rochester Brain and Spine Neuro
🇺🇸Rochester, New York, United States
Upstate Orthopedics
🇺🇸Syracuse, New York, United States
Crouse Hospital
🇺🇸Syracuse, New York, United States
Carolina Neurosurgery and Spine Specialists
🇺🇸Charlotte, North Carolina, United States
Neurosurgical Network, Inc.
🇺🇸Toledo, Ohio, United States
Oregon Neurosurgery
🇺🇸Springfield, Oregon, United States
Emory Orthopedics and Spine Center
🇺🇸Atlanta, Georgia, United States
University of Chicago Hospitals Section of Neurosurgery
🇺🇸Chicago, Illinois, United States
Spine Nevada
🇺🇸Reno, Nevada, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Southeastern Spine Institute
🇺🇸Mount Pleasant, South Carolina, United States
NeuroSpine Consultants, PA
🇺🇸Plano, Texas, United States
University of Wisconsin Medical School
🇺🇸Madison, Wisconsin, United States
Barrow Neurosurgical Associates
🇺🇸Phoenix, Arizona, United States
University of Miami School of Medicine
🇺🇸Miami, Florida, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
Indiana Spine Group
🇺🇸Indianapolis, Indiana, United States
Neurosurgery Associates
🇺🇸Salt Lake City, Utah, United States
Twin Cities Spine Center
🇺🇸Minneapolis, Minnesota, United States
Kellogg MD Brain & Spine
🇺🇸Portland, Oregon, United States
Neurosurgical Associates
🇺🇸Nashville, Tennessee, United States
Wake Forest University School of Medicine - Dept. of Neurosurgery Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Marquette General Brain & Spine Center
🇺🇸Marquette, Michigan, United States