Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of DDD Versus ACDF
1 other identifier
interventional
494
1 country
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2003
Longer than P75 for not_applicable
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 16, 2007
CompletedFirst Posted
Study publicly available on registry
February 19, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedMay 13, 2016
May 1, 2016
3.5 years
February 16, 2007
May 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in patient pain and ability to function
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
Study Arms (2)
Anterior Cervical Discectomy Fusion
ACTIVE COMPARATORBRYAN Cervical Disc Prosthesis
EXPERIMENTALBRYAN Cervical Disc Prosthesis is a cervical intervertebral disc prosthesis designed to provide for motion like the normal cervical functional spinal unit.
Interventions
Control treatment is commercially available allograft (without bone matrix paste) used in conjunction with the Medtronic Safamor Danek ATLANTIS™ Cervical Plate System.
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.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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;
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Barrow Neurosurgical Associates
Phoenix, Arizona, 85013, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Silicon Valley Spine Institute
Campbell, California, 95008, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Hoag Memorial Hospital
Newport Beach, California, 92663, United States
Bay Area Spine Institute
Walnut Creek, California, 94598, United States
North Florida Regional Medical Center
Gainesville, Florida, 32605, United States
University of Miami School of Medicine
Miami, Florida, 33136, United States
Tallahassee Neurological Clinic
Tallahassee, Florida, 32308, United States
Emory Orthopedics and Spine Center
Atlanta, Georgia, 30329, United States
Northwestern University Department of Neurosurgery
Chicago, Illinois, 60611, United States
University of Chicago Hospitals Section of Neurosurgery
Chicago, Illinois, 60637, United States
Chicago Inst. of Neurosurgery and Neuro Research
Chicago, Illinois, 60640, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Indiana Spine Group
Indianapolis, Indiana, 46260, United States
Neurosurgery Associates
Scarborough, Maine, 04074, United States
Maryland Brain & Spine
Annapolis, Maryland, 21401, United States
Neurosurgery of Kalamazoo
Kalamazoo, Michigan, 49048, United States
Marquette General Brain & Spine Center
Marquette, Michigan, 49855, United States
Cervical Spine Specialists
Edina, Minnesota, 55439, United States
Twin Cities Spine Center
Minneapolis, Minnesota, 55404, United States
Columbia Orthopaedic Group
Columbia, Missouri, 65201, United States
Washington University Orthopedics
St Louis, Missouri, 63110, United States
Spine Nevada
Reno, Nevada, 89502, United States
Rochester Brain and Spine Neuro
Rochester, New York, 14623, United States
Upstate Orthopedics
Syracuse, New York, 13029, United States
Crouse Hospital
Syracuse, New York, 13210, United States
Carolina Neurosurgery and Spine Specialists
Charlotte, North Carolina, 28204, United States
Wake Forest University School of Medicine - Dept. of Neurosurgery Medical Center
Winston-Salem, North Carolina, 27157, United States
Neurosurgical Network, Inc.
Toledo, Ohio, 43608, United States
Kellogg MD Brain & Spine
Portland, Oregon, 97086, United States
Oregon Neurosurgery
Springfield, Oregon, 97477, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Southeastern Spine Institute
Mt. Pleasant, South Carolina, 29464, United States
Neurosurgical Associates
Nashville, Tennessee, 37203, United States
NeuroSpine Consultants, PA
Plano, Texas, 75093, United States
Neurosurgery Associates
Salt Lake City, Utah, 84103, United States
University of Wisconsin Medical School
Madison, Wisconsin, 53792, United States
Related Publications (3)
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.
PMID: 21938372BACKGROUNDHeller 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.
PMID: 19112337BACKGROUNDArnold 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.
PMID: 27129045DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rick C Sasso, MD
Indiana Spine Group
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2007
First Posted
February 19, 2007
Study Start
June 1, 2003
Primary Completion
December 1, 2006
Study Completion
May 1, 2016
Last Updated
May 13, 2016
Record last verified: 2016-05