OBJECTIVE:
The current cervical disc arthroplasty is limited by postoperative facet joint arthritis, heterotopic ossification and segmental kyphosis. The total Frisbee disc, which has an upper convex/concave non-spherical surface and a lower flat sliding surface, is a new approach for improved outcomes. Prior to clinical application, safety and suitability tests are required.
METHODS:
The Frisbee is the first 3rd generation disc according to a new classification of total disc because it can precisely mimic the segmental ROM, including the soft limitation of axial rotation. The ISO 18192-1 test was carried out to determine the rate of wear debris. A FE model was used to assess the safety of prosthetic components. In the sagittal plane several variables to determine the most favorable lordotic angle were evaluated.
RESULTS:
Two angled prosthetic plates are safer than one sliding angled core to prevent the displacement. The lordosis of 7° of the Frisbee leads to kyphosis of no more than 2° without reduction of the ROM. The wear rate of the Frisbee is five times smaller compared to an FDA-approved disc with a spherical sliding surface.
CONCLUSIONS:
Based on the test results, the clinical application of Frisbee can now be studied. The postoperative kyphosis observed with other devices is not an issue with the Frisbee design. Physiological ROM is combined with the significant reduction of wear debris. For these reasons the Frisbee has the potential to provide a better balanced segmental loading reducing the degeneration of the joint surface and heterotopic ossification.
Arthroplasty, replacement; Cervical vertebrae; Intervertebral disc; Joint prosthesis
