The spinal cord terminates at the level of the highest lumbar vertebrae (L1-L2). The lumbar spinal canal is filled by the extension of the spinal cord, cauda equina, which is composed of the spinal nerve roots. The nerve roots exit the spinal canal pairwise through intervertebral openings (foramina). A branch innervating the tissues in the back departs from each of the spinal nerve roots. There are nerve endings transmitting pain sensations (nociceptive endings) in muscles, ligaments and joints. In a healthy intervertebral disc there are no such nerve endings except for the outermost parts of the annulus. Yet, the disc is considered the most important source of low-back pain. Annular ruptures are known to be painful. As a sequel of disc degeneration a herniation of the semigelatinous inner part of the intervertebral disc, the nucleus, can occur into the spinal canal and lead to compression and/or inflammation of a spinal nerve along with symptoms and signs of sciatica, as shown in .
The mid-term follow-up on four devices have been reported at this time. The trial results remain consistent, non-inferiority when compared to anterior cervical discectomy and fusion and reoperation.
Patient FAQs | Mobi-C Cervical Disc | Zimmer Biomet
The PCM and Secure C devices were granted FDA PMA in 2012, the Mobi-C prosthesis in 2013, and the Prestige LP Cervical Disc in 2014; but long-term studies are ongoing, and the data is still not published. Other artificial intervertebral discs have been developed and are currently being investigated in clinical trials. The FDA actively tracks devices whose approvals are contingent upon a post approval long-term study. Some contraindications from the FDA labels for the artificial intervertebral cervical disc devices include the following:
Cervical disc Prosthesis Model 2 - Orion Farma Tıbbi Ürünler
Hybrid constructs in a single procedure, involving cervical fusion with cervical artificial intervertebral disc implantation is considered investigational for all indications. Concurrent or planned sequential artificial cervical disc replacement with cervical spinal fusion are investigational for the management of neck pain, spinal disorders, and all other indications at all times.
(also called a disc replacement, disc prosthesis or spine ..
At the present time, there is limited published information about the impact of cervical arthroplasty devices on clinical outcomes over the long term. The rates of device failure and the need for reoperations due to device failure or malfunction are not well defined. Reports of device failure that occur at time periods longer than the average follow-up in the clinical trials highlights the need for longer term studies. While the early results are encouraging, given the natural history of the disease, in particular any effect of the device on adjacent-level disc degeneration, device durability, adverse events, and ability to revise need to be studied in the long term. Longer term results are expected of the disc to more fully characterize adverse events in a broader patient population. The rates of device failure and the need for reoperations due to device failure or malfunction are not well-defined. Reports of device failure that occur at time periods longer than the average follow-up in the clinical trials highlights the need for longer term studies to further define these adverse events. At this time there needs to be further study on the high rate of ossification, device longevity, and the clinical significance of adverse events in the long term.
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As an alternative, a variety of artificial intervertebral discs have been investigated over the past 30 years as an alternative to fusion. This approach, also referred to as total disc replacement or spinal arthroplasty, is intended to maintain motion at the operative level once the damaged disc has been removed, and to maintain the normal biomechanics of the adjacent vertebrae. It is hypothesized that artificial disc will maintain anatomical disk space height, normal segmental lordosis, and physiological motion patterns at the index and adjacent cervical levels. The potential to reduce the risk of adjacent-level degenerative disc disease above or below a fusion site has been the major rationale driving device development and use.