The viscoelastic cervical disk prosthesis CP-ESP is an innovative one-piece deformable but cohesive interbody spacer. It is an evolution of the LP-ESP lumbar disk implanted since 2006. The implant provides 6 full degrees of freedom including shock absorption. The design allows a limitation for rotation and translation with resistance to motion (elastic return property) aimed at avoiding overload of the posterior facets. The rotation center can vary freely during motion. It thus differs substantially from current prostheses. This study reports the clinical results of a prospective observational study series of 89 patients who are representative of the current use of the ESP implant since 2012. The radiological results are focused on the evolution of the mean center of rotation (MCR) as an additional information to the range of motion (ROM) for the evaluation of the quality of spine movement. 89 patients (33 males, mean age 45 years [28–60], 107 implants) were included for an open, prospective and non-randomized study between October 2012 and December 2015. One level patients were at C3C4 (3), C4C5 (3), C5C6 (41) C6C7 (24) C7T1 (1) Two levels patients were C4C5/C5C6 (3), C5C6/C6C7 (12), C6C7/C7D1 (1) and 3 levels C4C5/C5C6/C6C7 (1)Introduction
Materials and Methods
To determine if clinical outcomes are correlated with center of rotation (COR) in patients implanted with a viscoelastic total disc replacement (VTDR). Fifty patients with single-level, symptomatic lumbar DDD between L4 and S1 were enrolled in a clinical trial of a VTDR across three surgical centres. A comprehensive, independent review and statistical analysis of both clinical and radiographic outcomes was performed and analyzed for correlations. Data from preoperative through 2 years were available. The COR was calculated for the index levels and compared to data for an asymptomatic population. Each COR coordinate was classified as abnormal if outside of the 95% confidence interval for an asymptomatic population.Purpose
Methods
