Document Type

Conference Proceeding

Publication Date

12-2024

Publication Title

Abstract Book 52nd Annual Meeting

Abstract

Introduction: Cervical total disc replacement (cTDR) has gained acceptance as a treatment for symptomatic disc degeneration with symptoms of radiculopathy with/without myelopathy. While clinical outcomes of cTDR have consistently been reported to be similar or superior to those of cervical discectomy and fusion, there are limited reports addressing differences related to patient age. The purpose of this study was to compare the 4-year results of two-level PEEKon-ceramic cervical TDR for patients ≥60 years old to those < 60. Materials and Methods: Data were from the prospective Food and Drug Administration (FDA) Investigational Device Exemption (IDE) trial for the Simplify cervical disc. The study included 145 patients who completed 4-year follow-up, of which 124 were < 60 years old at the time of surgery and 21 were ≥60 years. All patients were treated for two-level cervical disc degeneration with radiculopathy and/or myelopathy. Clinical outcome was based on the Neck Disability Index (NDI), neck pain and arm pain intensity scores (10-point scale), and neurologic status. Radiographic measures included flexion/extension (F/E) range of motion (ROM), disc space height, heterotopic ossification, and adjacent-level degeneration based on Kellgren-Lawrence grading. Mean 48-month outcomes for patients ≥60 years old were compared to those of patients < 60. Radiographs were evaluated by an independent lab specializing in image assessment. Results: Of the outcomes reviewed, only one statistically significant difference was detected based on age group. The mean change in F/E ROM from baseline to 48 months at the inferior index level was 3.33° (< 60) and -0.19° (≥60) (p=0.01). At the superior index level, the difference was not significant (1.80° (< 60) vs. 0.12° (≥60); p=0.20). The difference in change in global ROM was also not significant (5.67° (< 60) vs. 0.77° (≥60); p=0.07). Statistically significant differences were not seen for the other outcomes assessed: mean change in NDI, mean change in neck pain, mean change in arm pain. Neurologic status was normal in 93.6% of the < 60 age group and 100.0% of the ≥60 group (p=0.24). The mean change in average disc height from baseline to 48 months was similar in both groups. The distribution of Kellgren-Lawrence grades (none, doubtful, minimal, moderate, and severe) was also similar for each age group for the level above and below the surgical levels (p=0.88 above, p=0.49 below) and the rate of radiographically relevant HO (grade 3 or 4) was comparable between age groups (superior level (p=0.49); inferior level (p=0.20)). Through latest follow-up, there were zero secondary surgical interventions in the ≥60 cohort and 9 in the < 60 cohort. Conclusion: This study found that patients ≥60 years of age who were treated with PEEK-on-ceramic TDR at two levels had comparable clinical and radiographic outcomes to patients < 60 years of age through 4-year follow-up. These results affirm that cervical TDR performs similarly in patients ≥60 versus those < 60, although the small sample size of patients ≥60 years of age is a limitation.

First Page

308

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52nd Annual Meeting of the Cervical Spine Research Society, December 11-14, 2024, Chicago, IL

Last Page

309

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