Abstract
BACKGROUND: Short-and mid-term studies have demonstrated that cervical disc arthroplasty (CDA) can maintain or restore range of motion and sagittal alignment in select patients with cervical disc degeneration. Upon completion of the 7-year Mobi-C FDA study, follow-up continued out to 10 years on a subset of CDA patients from high-enrolling centers in the FDA study. This is an analysis of the radiographic outcomes of the first 98 CDA patients with 10-years follow-up.
PURPOSE: The purpose of this study is to present preliminary radiographic outcomes of the first 98 (approximately 50%) patients followed for 10-years in a multicenter study of cervical arthroplasty for one- and two-level pathology.
STUDY DESIGN: This was a prospective cohort study of patients treated with cervical disc replacement at one- or two contiguous levels using the Mobi-C® Cervical Disc. Following completion of the 7-year FDA post approval study, follow-up was extended to 10 years for consenting patients at seven high-enrolling centers. The primary inclusion criteria were cervical degenerative disc at one or two contiguous levels and no prior cervical operations.
OUTCOME MEASURES: All radiographic evaluations were conducted by independent radiologists (Medical Metrics, Inc., Houston, TX). Radiographic endpoints included segmental and global range of motion, sagittal alignment, adjacent level degeneration (ALD) and heterotopic ossification (HO). The Kellgren-Lawrence scale of disc degeneration was used to define radiographic ALD. HO was classified using the system adapted from McAfee and Mehren. HO grades 3 and 4 were classified as clinically relevant due to restricted ROM.
RESULTS: Ten-year radiographic follow-up has been obtained from 98 CDA patients (53 2-level; 45 1-level) at 7 centers. There were no significant differences in demographic factors or preoperative patient-reported outcomes between these patients and the original FDA cohort.
Meeting Program Click Here
