The International Society for the Advancement of Spine Surgery awarded the Charles D. Ray Award for Best Clinical Paper to a study comparing one-level total disc replacement patients to anterior cervical discectomy and fusion patients.
The award was presented at the ISASS annual conference earlier this year. Here are five things to know about the award-winning paper and its authors.
1. Michael Hisey, MD, of Texas Back Institute; Reginald Davis, MD, of Greater Baltimore Medical Center; Hyun Bae, MD, of Cedars-Sinai Spine Center; Kee D. Kim, MD, of UC Davis Health System; S.E. Gaede, MD, of Oklahoma Spine & Brain Institute; and Pierce Nunley, MD, of the Spine Institute of Louisiana authored the paper. The paper was titled "Sagittal Alignment of One-level TDR and ACDF Patients: An Analysis of Patient Outcomes from a Randomized, Prospective, Clinical Trial."
2. The trial examined LDR's Mobi-C investigational device exemption results, finding that ACDF patients with kyphotic C2-C7 angle at 24 months had significantly worse outcomes in NDI score, satisfaction and SF-12 Mental Component Score than those with lordic C2-C7.
3. There was no significant difference in outcomes between the C2-C7 lordic and kyphotic Mobi-C patients at 24 months after surgery. This is an improvement over patients who received fusion. "We feel that the growing body of long-term evidence on Mobi-C, including what was presented at the ISASS annual meeting, further supports the role this technology has in providing patients with a treatment alternative to fusion," said LDR President and CEO Christophe Lavigne.
4. There were six podium presentations discussing Mobi-C at the ISASS annual meeting. The papers compared one- and two-level fusion procedures with one- and two-level cervical disc replacements. Mobi-C is the only cervical total disc replacement in the United States with FDA approval for both one- and two-level procedures.
5. An additional two studies examined sagittal alignment of two-level total disc replacement patients. The first found both lordic and kyphotic two-level Mobi-C patients had similar pain relief and satisfaction at 24 months postoperatively. The second compared two-level procedures to fusion and found significantly greater improvement in personal care, work, headaches, reading, lifting and recreation headaches among the disc arthroplasty group.
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