Abstract
INTRODUCTION
Lumbar 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 have been developed to more effectively replicate the shock absorption and flexural stiffness of native disc. This study reports 5 years clinical and radiographic outcomes, range of motion and position of the center of rotation after a viscoelastic TDR.
Material and methods
This prospective observational cohort study included 61 consecutive patients with monosegmental TDR. We selected patients with intermediate functional activity according to Baecke score. Hybrid constructs had been excluded. Only cases with complete clinical and radiological follow-up at 3, 6, 12, 24 and 60 months were included. Mean age at the time of surgery was 42.8 +7.7 years-old (27–60) and mean BMI was 24.2 kg/m² +3.4 (18–33). TDR level was L5-S1 in 39 cases and L4-L5 in 22 cases.
The clinical evaluation was based on Visual Analog Scale (VAS) for pain, Oswestry Disability Index (ODI) score, Short Form-36 (SF36) including physical component summary (PCS) and mental component summary (MCS) and General Health Questionnaire GHQ28. The radiological outcomes were range of motion and position of the center of rotation at the index and the adjacent levels and the adjacent disc height changes.
Results
There was a significant improvement in VAS (3.3±2.5 versus 6.6±1.7, p<0.001), in ODI (20±17.9 versus 51.2±14.6, p<0.001), GHQ28 (52.6±15.5 versus 64.2±15.6, p<0.001), SF 36 PCS (58.8±4.8 versus 32.4±3.4, p<0.001) and SF 36 MCS(60.7±6 versus 42.3±3.4, p<0.001).
Additional surgeries were performed in 5 cases. 3 additional procedures were initially planified in the surgical program: one adjacent L3-L5 ligamentoplasty above a L5S1 TDR and two L5S1 TDR cases had additional laminectomies. Fusion at the index level was secondary performed in 2 L4L5 TDR cases but the secondary posterior fusion did not bring improvement. In the 56 remaining patients none experienced facet joint pain. One patient with sacroiliac pain needed local injections.
Radiological outcomes were studied on 56 cases (exclusion of 5 cases with additional surgeries).
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 Ziegler, all of our cases remained grade 0 for disc height (within 25% of normal)
Discussion
The silent block design of LP-ESP provides an interesting specificity. It could be the key factor that makes the difference regarding facets problems and instability reported with other implants experimentally or clinically. Unfortunately no other comparative TDR series are available yet in the literature.
Conclusion
This series reports significant improvement in mid-term 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.
