Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of DDD Versus ACDF
NCT ID: NCT00437190
Last Updated: 2016-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
494 participants
INTERVENTIONAL
2003-06-30
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Anterior Cervical Discectomy Fusion
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.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
21 Years
ALL
No
Sponsors
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Medtronic Spinal and Biologics
INDUSTRY
Responsible Party
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Principal Investigators
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Rick C Sasso, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana Spine Group
Locations
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Barrow Neurosurgical Associates
Phoenix, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Silicon Valley Spine Institute
Campbell, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Hoag Memorial Hospital
Newport Beach, California, United States
Bay Area Spine Institute
Walnut Creek, California, United States
North Florida Regional Medical Center
Gainesville, Florida, United States
University of Miami School of Medicine
Miami, Florida, United States
Tallahassee Neurological Clinic
Tallahassee, Florida, United States
Emory Orthopedics and Spine Center
Atlanta, Georgia, United States
Northwestern University Department of Neurosurgery
Chicago, Illinois, United States
University of Chicago Hospitals Section of Neurosurgery
Chicago, Illinois, United States
Chicago Inst. of Neurosurgery and Neuro Research
Chicago, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Indiana Spine Group
Indianapolis, Indiana, United States
Neurosurgery Associates
Scarborough, Maine, United States
Maryland Brain & Spine
Annapolis, Maryland, United States
Neurosurgery of Kalamazoo
Kalamazoo, Michigan, United States
Marquette General Brain & Spine Center
Marquette, Michigan, United States
Cervical Spine Specialists
Edina, Minnesota, United States
Twin Cities Spine Center
Minneapolis, Minnesota, United States
Columbia Orthopaedic Group
Columbia, Missouri, United States
Washington University Orthopedics
St Louis, Missouri, United States
Spine Nevada
Reno, Nevada, 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
Wake Forest University School of Medicine - Dept. of Neurosurgery Medical Center
Winston-Salem, North Carolina, United States
Neurosurgical Network, Inc.
Toledo, Ohio, United States
Kellogg MD Brain & Spine
Portland, Oregon, United States
Oregon Neurosurgery
Springfield, Oregon, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Southeastern Spine Institute
Mt. Pleasant, South Carolina, United States
Neurosurgical Associates
Nashville, Tennessee, United States
NeuroSpine Consultants, PA
Plano, Texas, United States
Neurosurgery Associates
Salt Lake City, Utah, United States
University of Wisconsin Medical School
Madison, Wisconsin, United States
Countries
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References
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Sasso RC, Anderson PA, Riew KD, Heller JG. Results of cervical arthroplasty compared with anterior discectomy and fusion: four-year clinical outcomes in a prospective, randomized controlled trial. J Bone Joint Surg Am. 2011 Sep 21;93(18):1684-92. doi: 10.2106/JBJS.J.00476.
Heller JG, Sasso RC, Papadopoulos SM, Anderson PA, Fessler RG, Hacker RJ, Coric D, Cauthen JC, Riew DK. Comparison of BRYAN cervical disc arthroplasty with anterior cervical decompression and fusion: clinical and radiographic results of a randomized, controlled, clinical trial. Spine (Phila Pa 1976). 2009 Jan 15;34(2):101-7. doi: 10.1097/BRS.0b013e31818ee263.
Arnold PM, Anderson KK, Selim A, Dryer RF, Kenneth Burkus J. Heterotopic ossification following single-level anterior cervical discectomy and fusion: results from the prospective, multicenter, historically controlled trial comparing allograft to an optimized dose of rhBMP-2. J Neurosurg Spine. 2016 Sep;25(3):292-302. doi: 10.3171/2016.1.SPINE15798. Epub 2016 Apr 29.
Other Identifiers
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BRYAN(R) Cervical Disc IDE
Identifier Type: -
Identifier Source: org_study_id
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