The BRYAN® Cervical Disc is indicated in skeletally mature patients for reconstruction
of the disc from C3-C7 following single-level discectomy for intractable radiculopathy
and/or myelopathy. The BRYAN® device is implanted via an open anterior approach.
Intractable radiculopathy and/or myelopathy is defined as any combination of
the following: disc herniation with radiculopathy, spondylotic radiculopathy, disc
herniation with myelopathy, or spondylotic myelopathy resulting in impaired function
and at least one clinical neurological sign associated with the cervical level to be
treated, and necessitating surgery as demonstrated using computed tomography (CT),
myelography and CT, and/or magnetic resonance imaging (MRI). Patients receiving
the BRYAN® Cervical Disc should have failed at least six weeks of non-operative
treatment prior to implantation of the BRYAN® Cervical Disc.
The BRYAN® Cervical Disc should not be implanted in patients with an active infection
or with an allergy to titanium, polyurethane or ethylene oxide residues, active systemic
infection or infection at the operating site; osteoporosis defined as a DEXA bone
mineral density T-score equal to or worse than -2.5; moderate to advanced spondylosis
characterized by bridging osteophytes, marked reduction or absence of motion, or
collapse of the intervertebral disc space of greater than 50% of its normal height;
marked cervical instability on radiographs (e.g., radiographic signs of subluxation
greater than 3.5mm or angulation of the disc space more than 11 degrees greater
than adjacent segments); significant cervical anatomical deformity or compromised
vertebral bodies at the index level (e.g., ankylosing spondylitis, rheumatoid arthritis,
or compromise due to current or past trauma); significant kyphotic deformity or
significant reversal of lordosis; or symptoms necessitating surgical treatment at more
than one cervical level.
The BRYAN® Cervical Disc should only be used by surgeons who are experienced in the
surgical procedure and have undergone adequate training with the device. A lack of
adequate experience and/or training may lead to a higher incidence of adverse events,
such as neurological complications.
The safety and effectiveness of this device has not been established in patients with the
following conditions: axial neck pain as solitary symptom; not skeletally mature; prior
cervical spine surgery, including prior surgery at the index level; facet joint pathology
of involved vertebral bodies; active malignancy; Paget's disease, osteomalacia, or
other metabolic bone disease; chronic or acute renal failure or history of renal disease;
taking medications known to potentially interfere with bone/soft tissue healing (e.g.,
steroids); pregnant; unstable cardiac disease; diabetes mellitus requiring daily insulin
management; and extreme obesity as defined by the NIH Clinical Guidelines Body
Mass Index (i.e., BMI ≥40); less than 21 years of age and were not refractory to at least
six weeks of unsuccessful conservative treatment or had signs of progression or spinal
cord/nerve root compression with continued non-operative care.
Implanted metal alloys release metallic ions into the body. The long-term effect of
these ions on the body is not known. Patients in the clinical study were instructed to
use non-steroidal anti-inflammatory drugs (NSAIDs) for two weeks postoperatively.
Dosing and frequency were left to the discretion of the physician. It has been reported
in the literature that short-term postoperative use of NSAIDs may reduce the instance
of heterotopic ossification.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician
the BRYAN® Cervical Disc System video editing software free | |
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| Education | Upload TimePublished on 5 Feb 2013 |
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