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.