Sunnyvale, Calif.-based Simplify Medical develops the Simplify cervical artificial disc, which is currently an investigational device in the U.S. The Simplify disc has earned the CE Mark, with surgeons treating 600 patients outside the United States so far.
Consisting of PEEK-on-ceramic materials, the device is intended to limit patient exposure to CT high-dose ionizing radiation by allowing surgeons to view MRIs without artifact disruption.
The company is enrolling patients in a clinical trial to compare one-level cervical disc implantation between C3 to C7 with cervical fusion surgery from a historical nonconcurrent control group.
Another study, published in BMC Musculoskeletal Disorders, investigated the magnitude of CT imaging for post-operative assessment of spine surgery. The study used data from a Humana database between 2007 and 2014, gathering adjudicated claims for more than 130,000 complex spine surgeries.
Here are four study observations:
1. The study revealed CT prevalence rose more than two-fold from six months to five years following complex spine surgery, with patients averaging two scans within that time period.
2. Each of those CT scans delivered radiation equal to about 400 to 550 chest X-rays.
3. While patients often receive MRIs before surgery, surgeons tend to prefer CTs after surgery. This preference is due to spinal implants containing metal, which create artifacts in MRI images and impact visualization of the facets and adjacent levels.
4. The study authors "detected a high frequency of CT utilization following complex spine surgery," which may result in higher cancer risk. They suggest surgeons use "non-ferromagnetic implant biomaterials that facilitate MRI post-operatively," to avoid this risk.