Document Type

Conference Proceeding

Publication Date

12-2024

Publication Title

Abstract Book 52nd Annual Meeting

Abstract

Introduction: In 2013, the first Investigational Device Exemption (IDE) clinical trial for the treatment of Symptomatic Cervical Disc Disease (SCDD) at two contiguous levels was approved for an unconstrained Total Disc Replacement (cTDR). A decade later, this same device was the control arm of a new IDE trial at 2 levels. Although different investigators, the objective of this analysis was to explore if a decade of knowledge demonstrated a significant improvement in patient outcomes compared to the original trial. Materials and Methods: Both studies were prospective, randomized, multi-center, controlled IDE clinical trials with similar inclusion/exclusion criteria and study designs. The original IDE trial had 148 cTDR patients and the new IDE trial had 140 cTDR patients treated at 2 levels with the same unconstrained device. Patients were seen at the same intervals of follow-up at 6 weeks, 3 months, 6 months, 12 months, and 24 months. Patient-reported outcome measures and radiographs were collected at follow up. Both studies were based on non-inferiority models with a primary endpoint. The composite clinical success (CCS) at 24 months was defined as a patient must be a success in all 4 criteria, defined as: ≥ 15 point improvement in Neck Disability Index (NDI) Score (out of 100) in subjects at 24 months compared with baseline, maintenance or improvement in neurological status at 24 months compared to baseline, no secondary surgical interventions at the index levels, and absence of major device-related adverse events (AEs). Secondary endpoints such as Visual Analog Score (VAS) neck pain, VAS arm pain, ShortForm-12 (SF-12) and patient satisfaction were collected at each time point in both studies. Results: At 24 months, the original trial with neurologic status added CCS was achieved in 76.3% (Hisey et al, 2014) compared to a CCS success of 86.1% in the new trial demonstrating a statistically significant difference (p < 0.05). There was a lower incidence of secondary surgical interventions in the original study (98.8% success) compared to new study (96.4% success), however not statistically different. The original study reported 8 patients with AEs and 1 patient with neurologic deterioration (ND). In comparison, the new study had 0 AEs and 2 patients with NDs demonstrating a statistically significant difference favoring the new study. All secondary endpoints consistently showed similar improvement from baseline in both studies but none of the measures showed a statistically significant difference between studies. Conclusion: This is truly a unique opportunity to compare data from 2 IDE trials with the same treatment group. This ad hoc analysis shows that the advancement of knowledge over a decade in spinal surgery has reduced major device-related adverse events. However, secondary surgical interventions remains low in both trials and patient reported outcomes show high success in both trials with a statistical difference between the trials. In summary, this comparison shows an improvement in surgical expertise and planning over a decade while patient overall success remains extremely high. This validates the reproducibility of clinical outcomes over many surgeons and centers.

First Page

315

Comments

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

Last Page

316

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