Survivorship analysis of 150 consecutive patients with DIAM™ implantation for surgery of lumbar spinal stenosis and disc herniation

Abstract

Recently, the Device for Intervertebral Assisted Motion (DIAM™) has been introduced for surgery of degenerative lumbar disc diseases. The authors performed the current study to determine the survivorship of DIAM™ implantation for degenerative lumbar disc diseases and risk factors for reoperation. One hundred and fifty consecutive patients underwent laminectomy or discectomy with DIAM™ implantation for primary lumbar spinal stenosis or disc herniation. The characteristics of the 150 patients included the following: 84 males and 66 females; mean age at the time of surgery, 46.5 years; median value of follow-up, 23 months (range 1-48 months); 96 spinal stenosis and 54 disc herniations; and 146 one-level (115, L4-5; 31, L5-6) and 4 two-level (L4-5 and L5-6). In the current study, due to lumbosacral transitional vertebra (LSTV) L6 meant lumbarization of S1 and this had a prominent spinous process so that the DIAM™ was implanted at L5-6. Reoperations due to any reasons of the DIAM™ implantation level or adjacent levels were defined as a failure and used as the end point for determining survivorship. The cumulative reoperation rate and survival time were determined via Kaplan-Meier analysis. The log-rank test and Cox regression model were used to evaluate the effect of age, gender, diagnosis, location, and level of DIAM™ implantation on the reoperation rate. During a 4-year follow-up, seven patients (two males and five female) underwent reoperation at the DIAM™ implantation level, giving a reoperation rate of 4.7%. However, no patients underwent reoperation for adjacent level complications. The causes of reoperation were recurrent spinal stenosis (n = 3), recurrent disc herniation (n = 2), post-laminectomy spondylolisthesis (n = 1), and delayed deep wound infection (n = 1). The mean time between primary operation and reoperation was 13.4 months (range 2-29 months). Kaplan-Meier analysis predicted an 8% cumulative reoperation rate 4 years post-operatively. Survival time was predicted to be 45.6 ± 0.9 months (mean ± standard deviation). Based on the log-rank test, the reoperation rate was higher at L5-6 (p = 0.002) and two-level (p = 0.01) DIAM™ implantation compared with L4-5 and one-level DIAM™ implantation. However, gender (p = 0.16), age (p = 0.41), and diagnosis (p = 0.67) did not significantly affect the reoperation rate of DIAM™ implantation. Based on a Cox regression model, L5-6 [hazard ratio (HR), 10.3; 95% CI, 1.7-63.0; p = 0.01] and two-level (HR, 10.4; 95% CI, 1.2-90.2; p = 0.04) DIAM™ implantation were also significant variables associated with a higher reoperation rate. Survival time was significantly lower in L5-6 (47 vs. 22 months, p = 0.002) and two-level DIAM™ implantation (46 vs. 18 months, p = 0.01) compared with L4-5 and one-level DIAM™ implantation. The current results suggest that 8% of the patients who have a DIAM™ implantation for primary lumbar spinal stenosis or disc herniation are expected to undergo reoperation at the same level within 4 years after surgery. Based on the limited data set, DIAM™ implantation at L5-6 and two-level in patients with LSTV are significant risk factors for reoperation.