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

Completed · Not applicable

Conditions studied: Radiculopathy, Myelopathy, Cervical Degenerative Disc Disease

In brief

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.

Key facts

Study ID

NCT00437190

Run by

Medtronic Spinal and Biologics

People needed

494

Starts

2003-06-01

Expected to finish

2016-05-01

Last updated by the study team

2016-05-13

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

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;
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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