Improvements sustained at 10 years for patients treated with the Mobi-C cervical disc; in the trial that led to its approval by the US Food and Drug Administration (FDA) in 2013, a new study shows. This included maintenance of scores for pain, neck disability, and neurologic status; with no worsening of radiographic adjacent segment degeneration as compared with earlier follow-up. In addition, 98.4% of patients were still satisfied with the surgery 10 years later, researchers report.
“Their question was whether the improvements they see at 7 years sustained further ou; so they followed patients after the study was completed. “They saw that CDA patients continued to have sustained improvement at 10 years.” Short- and mid-term studies have shown the effectiveness of CDA to treat cervical disc degeneration. The purpose of this study was to analyze the 10-year outcomes of the multicenter experience in patients with CDA at 1 or 2 contiguous levels.
Refractory to nonsurgical treatment
Therefore the patients had degenerative disc disease refractory to nonsurgical treatment and no prior cervical operations; they randomly assigned 2:1 to CDA or fusion. Upon completion of the 7-year study, follow-up continued at 10 years for consenting patients at nine high-enrolling centers. But outcomes included neck and arm pain neck disability index (NDI), neurologic status, patient satisfaction, secondary surgery, and adverse events. Radiographic endpoints included a segmental and global range of motion (ROM), sagittal alignment, adjacent level degeneration, and heterotopic ossification.
Ten-year follow-up was obtained from 187 of 231 eligible patients (81%). Mean follow-up was 10.2 years and the longest follow-up was 11.2 years. Radiographs obtained from 170 patients (73.6%) at 10 years. So there is no significant differences in demographics or preoperative characteristics between the 10-year cohort and the original FDA cohort.
Motion at a disc space
“The rate of adjacent level disease increases with the number of levels you fuse; so by protecting motion and the ability to have three or four degrees of motion at a disc space They think this is protective because it allows less strain at adjacent levels,” Vanderveer continued. “I think more time will provide more data that increases that opinion.”
“Just coming into our office and saying, ‘They have cervical spondylosis and a disc rupture and I want an artificial disc’ will not get them one,” he said. “They will look at their X-rays and determine if they are good or poor candidates. But they won’t put this in if you’re a poor candidate. Now have a wide-ranging tool kit to deal with different conditions. That’s the granularity of determining who would benefit the most.
Zimmer Biomet sponsored the cervical disc FDA clinical trial and contributed to the design and conduct of the study and provided assistance with analysis of data. The authors reported receiving assistance from Zimmer Biomet for the preparation of this presentation. Kim disclosed no other relevant financial relationships. So VanDerVeer has disclosed no relevant financial relationships.