The innovative viscoelastic CP ESP cervical disk prosthesis with six degrees of freedom: biomechanical concepts, development program and preliminary clinical experience.

The viscoelastic cervical disk prosthesis ESP is an innovative one-piece deformable but cohesive interbody spacer. It is an evolution of the LP ESP lumbar disk implanted since 2006. CP ESP provides six full degrees of freedom about the three axes including shock absorbtion. The prosthesis geometry allows limited 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. The concept of the ESP prosthesis is fundamentally different from that of the devices currently used in the cervical spine. The originality of the concept of the ESP® prosthesis led to innovative and intense testing to validate the adhesion of the viscoelastic component of the disk on the titanium endplates and to assess the mechanical properties of the PCU cushion. The preliminary clinical and radiological results with 2-year follow-up are encouraging for pain, function and kinematic behavior (range of motion and evolution of the mean centers of rotation). In this series, we did not observe device-related specific complications, misalignment, instability or ossifications. Additional studies and longer patient follow-up are needed to assess long-term reliability of this innovative implant.

The LP-ESP(®) lumbar disc prosthesis with 6 degrees of freedom: development and 7 years of clinical experience.

The viscoelastic lumbar disk prosthesis-elastic spine pad (LP-ESP(®)) is an innovative one-piece deformable but cohesive interbody spacer providing 6 full degrees of freedom about the 3 axes, including shock absorption. A 20-year research program has demonstrated that this concept provides mechanical properties very close to those of a natural disk. Improvements in technology have made it possible to solve the problem of the bond between the elastic component and the titanium endplates and to obtain an excellent biostability. The prosthesis geometry allows limited 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, which are 2- or 3-piece devices involving 1 or 2 bearing surfaces and providing 3 or 5 degrees of freedom. This design and the adhesion-molding technology differentiate the LP-ESP prosthesis from other mono-elastomeric prostheses, for which the constraints of shearing during rotations or movement are absorbed at the endplate interface. Seven years after the first implantation, we can document in a solid and detailed fashion the course of clinical outcomes and the radiological postural and kinematic behavior of this prosthesis.

Five-year follow-up of clinical and radiological outcomes of LP-ESP elastomeric lumbar total disc replacement in active patients.

BACKGROUND CONTEXT: The surgical treatment of degenerative disc disease at the lumbar spine may involve fusion. Total disc replacement (TDR) is an alternative treatment to avoid fusion-related adverse events, specifically adjacent segment disease. New generation of elastomeric non-articulating devices has been developed to more effectively replicate the shock absorption and flexural stiffness of native disc. PURPOSE: To report 5 years clinical and radiographic outcomes, range of motion (ROM), and position of the center of rotation after a viscoelastic lumbar TDR. STUDY DESIGN: Prospective observational cohort study PATIENT SAMPLE: Sixty-one patients OUTCOME MEASURES: The clinical evaluation was based on visual analog scale (VAS) for pain, Oswestry disability index (ODI) score, short form-36 (SF-36) including the physical component summary (PCS) and the mental component summary (MCS), and general health questionnaire-28 (GHQ28). The radiological outcomes were ROM and position of the center of rotation at the index and the adjacent levels and the adjacent disc height changes. METHODS: Our study group included 61 consecutive patients with monosegmental disc replacement. We selected patients who could provide a global lumbar spine mobility analysis (intermediate functional activity according to the Baecke score). Hybrid constructs had been excluded. Only the cases with complete clinical and radiological follow-up at 3, 6, 12, 24, and 60 months were included. RESULTS: There was a significant improvement in VAS (3.3±2.5 vs. 6.6±1.7, p<.001), in ODI (20±17.9 vs. 51.2±14.6, p<.001), GHQ28 (52.6±15.5 vs. 64.2±15.6, p<.001), SF-36 PCS (58.8±4.8 vs. 32.4±3.4, p<.001), and SF-36 MCS (60.7±6 vs. 42.3±3.4, p<.001). The mean location centers of the index level and adjacent discs were comparable to those previously published in asymptomatic patients. According to the definition of Zigler and Delamarter, all of our cases remained grade 0 for adjacent level disc height (within 25% of normal). CONCLUSIONS: This series reports significant improvement in midterm follow-up after TDR, which is consistent with previously published studies but with a lower rate of revision surgery and no adjacent level disease pathologies. The radiographic assessment of the patients demonstrated the quality of functional reconstruction of the lumbar spine after LP-ESP viscoelastic disc replacement.

Clinical outcomes, radiologic kinematics, and effects on sagittal balance of the 6 df LP-ESP lumbar disc prosthesis.

BACKGROUND CONTEXT: Surgical treatment of degenerative disc disease remains a controversial subject. Lumbar fusion has been associated with a potential risk of segmental junctional disease and sagittal balance misalignment. Motion preservation devices have been developed as an alternative to fusion. The LP-ESP disc is a one-piece deformable device achieving 6 df, including shock absorption and elastic return. This is the first clinical report on its use. PURPOSE: To assess clinical outcomes and radiologic kinematics in the first 2 years after implantation. STUDY DESIGN: Prospective cohort of patients with LP-ESP total disc replacement (TDR) at the lumbar spine. PATIENT SAMPLE: Forty-six consecutive patients. OUTCOME MEASURES: Clinical outcomes were the visual analog scale (VAS) for pain, the Oswestry disability index (ODI), and the GHQ28 (General Health Questionnaire) psychological score. Radiologic data were the range of motion (ROM), sagittal balance parameters, and mean center of rotation (MCR). METHODS: Patients had single-level TDR at L4-L5 or L5-S1. Outcomes were prospectively recorded for 2 years (before and at 3, 6, 12, and 24 months after surgery). The SpineView software was used for computed analysis of the radiographic data. Paired t tests were used for statistical comparisons. RESULTS: No intraoperative complication occurred. All clinical scores improved significantly at 24 months: the back pain VAS scores by a mean of 4.1 points and the ODI by 33 points. The average ROM of the instrumented level was 5.4°±4.8° at 2 years and more than 2° for 76% of prostheses. The MCR was in a physiological area in 73% of cases. The sagittal balance (pelvic tilt, sacral slope, and segmental lordosis) did not change significantly at any point of the follow-up. CONCLUSIONS: Results from the 2-year follow-up indicate that LP-ESP prosthesis recreates lumbar spine function similar to that of the healthy disc in terms of ROM, quality of movement, effect on sagittal balance, and absence of modification in the kinematics of the upper adjacent level.