At the recently held American Association of Neurological Surgeons (AANS) 2019 Annual Scientific Meeting, researchers presented the results of a study showing that the use of an artificial cervical disc provided patients with significant post-surgical satisfaction 10 years after the device was implanted.
This is important information for patients and surgeons alike, as the test was initiated before the U.S. Food and Drug Administration )FDA) had even provided its approval for the Mobi-C cervical disc.
It was back in 2013 that the FDA first made the device available for use in the general public as an alternative to cervical spinal fusion, but the study looked at surveys on pain, neck disability and neurological status in 231 patients who received the device prior to that.
Of that group, 98.4% of patients remained satisfied 10 years later. Interestingly, the initial research project was only set at establishing patient satisfaction seven years after surgery, but a follow-up three years later revealed continued positive results.
According to Kee D. Kim, MD, professor and chief of spinal neurosurgery, University of California Davis,”Our question was whether the improvements we see at 7 years were sustained further out, so we followed patients after the study was completed. We saw that CDA [cervical disc arthroplasty] patients continued to have sustained improvement at 10 years.“
The discs are used to correct cervical disc degeneration and are offered as an alternative where appropriate to fusion surgery. Patients were asked about the following variables:
- Neck and arm pain
- Neck disability
- Patient satisfaction
- The need for secondary surgery
- Adverse events
Further studies quantifying range of motion, adjacent level degeneration, heterotopic ossification and sagittal alignment were conducted via diagnostic imaging. Of the 231 that started in the study, 1876 were still available for follow-up ten years later. 170 submitted to radiographs. The vast majority of patients continued to show significant improvement from where they had started, with some demonstrating that they had even improved in the last three years that were added on to the original study’s stated timeline.
One of the most important findings from the study was the fact that the areas of the spine that were adjacent to where the artificial discs had been implanted had not seen any additional level of degeneration in the years since the surgery.
“This is important. It’s what we really care about,” Kim said. “We feel a certain degree of protection is provided by placing an artificial disc instead of a fusion.“
Out of the original 231 patients, the researchers found that 5.1% required additional surgery at the same spot and another 4.7% needed surgery in an adjacent area. Kim explained that this is half the number likely to need additional surgery at the same spot following fusion surgery, and that more than twice as many fusion surgery patients need additional surgery in another area.
That is not to say that the device had a perfect record. Ten years after surgery there were 6 cases in which the artificial discs may have led to bone tissue formation and in two cases there may have been some sinking in, but in neither case was additional surgery required.
Though the device is not appropriate for every patient’s condition, the researchers were very pleased with the results in those for whom it was.
“These patients are now in their mid-50s. We don’t know what will happen in their 60s and 70s, but at 10 years CDA patients continue to have sustained improvements,” Kim concluded. “Our results through 10 years demonstrate that CDA with Mobi-C continues to be a safe and effective surgical treatment for patients with 1- or 2-level cervical degenerative disc disease.”
For information about treatment approaches that may be appropriate for your cervical spine pain, contact our New Jersey spine specialist to set up an appointment.