Postoperative Loss of Lumbar Lordosis Affects Clinical Outcomes in Patients with Pseudoarthrosis after Posterior Lumbar Interbody Fusion Using Cortical Bone Trajectory Screw Fixation

Study Design Retrospective cohort study. Purpose This study aimed to investigate relationships between clinical outcomes and radiographic parameters in patients with pseudoarthrosis after posterior lumbar interbody fusion (PLIF). Overview of Literature In some patients with pseudoarthrosis after PLIF, clinical symptoms improve following surgery, although pseudoarthrosis can often be one of the complications. However, there are no previous reports describing differences between patients with pseudoarthrosis after PLIF who have obtained better clinical outcomes and those who have not. Methods Twenty-seven patients who were diagnosed with pseudoarthrosis after single-level PLIF with cortical bone trajectory screw fixation (CBT-PLIF) were enrolled in this study. They were divided into two groups based on mean improvement of 22 points on the Oswestry Disability Index (ODI) at the 2-year follow-up. Group G consisted of 15 patients who showed improvement on the ODI of ≥22 points, and group P consisted of the residual 12 patients. Radiographic parameters, percentage of slip, lumbar lordosis (LL), segmental lordosis, segmental range of motion, screw loosening, and subsidence were compared between the two groups. Results There were no significant differences between the two groups on radiographic parameters except for postoperative changes in LL. Although surgery-induced changes in LL showed no significant difference between the two groups, changes in LL from before surgery to 2-year follow-up and during postoperative 2-year follow-up were significantly better in group G (mean change of LL: +3.5° and +5.1°, respectively) compared to group P (mean change of LL: −4.6° and −0.5°, respectively) (p<0.01 and 0.05, respectively). Conclusions Patients with greater improvement in ODI gained LL over the 2-year follow-up, whereas patients with less improvement in ODI lost LL during the 2-year follow-up. These results indicate that there is a significant correlation between clinical outcomes and LL even in patients with pseudoarthrosis after single-level CBT-PLIF

Fixation Strength of Caudal Pedicle Screws after Posterior Lumbar Interbody Fusion with the Modified Cortical Bone Trajectory Screw Method

Study DesignClinical case series.PurposeIn the posterior lumbar interbody fusion (PLIF) procedure in our institute, the cephalad screw trajectory follows a mediolateral and caudocephalad directed path according to the original cortical bone trajectory (CBT) method. However, the starting point of the caudal screw is at the medial border of the pedicle on an articular surface of the superior articular process, and the trajectory takes a mediolateral path parallel to the cephalad endplate. The incidence of caudal screw loosening after PLIF with this modified CBT screw method was investigated, and significant risk factors for caudal screw loosening were evaluated.Overview of LiteratureA biomechanical study of this modified caudal screw trajectory using the finite element method reported about a 20% increase in uniaxial yield pullout load compared with the traditional trajectory. However, there has been no clinical study concerning the fixation strength of this modified caudal screw trajectory.MethodsThe subjects were 193 consecutive patients who underwent single-level PLIF with modified CBT screw fixation. Caudal screw loosening was checked in computed tomography at 6 months after surgery, and screw loosening was defined as a radiolucency of 1 mm or more at the bone-screw interface.ResultsThe incidence of caudal screw loosening after lumbosacral PLIF (46.2%) was significantly higher than that after floating PLIF (6.0%). No significant differences in sex, brand of the instruments, and diameter and length of the caudal screw were evident between patients with and without caudal screw loosening. Patients with caudal screw loosening were significantly older at the time of surgery than patients without caudal screw loosening.ConclusionsFixation strength of the caudal screw after floating PLIF with this modified CBT screw technique was sufficiently acceptable. Fixation strength after the lumbosacral procedure was not

Study protocol for a multi-center, randomized controlled trial to develop Japanese denture adhesive guidelines for patients with complete dentures : the Denture Adhesive Guideline trial : study protocol for a randomized controlled trial

Background: Denture adhesives, characterized as medical products in 1935 by the American Dental Association, have been considered useful adjuncts for improving denture retention and stability. However, many dentists in Japan are hesitant to acknowledge denture adhesives in daily practice because of the stereotype that dentures should be inherently stable, without the aid of adhesives. The aim of this study is to verify the efficacy of denture adhesives to establish guidelines for Japanese users. The null hypothesis is that the application of denture adhesives, including the cream and powder types, or a control (isotonic sodium chloride solution) would not produce different outcomes nor would they differentially improve the set outcomes between baseline and day 4 post-application. Methods: This ten-center, randomized controlled trial with parallel groups is ongoing. Three hundred edentulous patients with complete dentures will be allocated to three groups (cream-type adhesive, powder-type adhesive, and control groups). The participants will wear their dentures with the denture adhesive for 4 days, including during eight meals (three breakfasts, two lunches, and three dinners). The baseline measurements and final measurements for the denture adhesives will be performed on the first day and after breakfast on the fourth day. The primary outcome is a general satisfaction rating for the denture. The secondary outcomes are denture satisfaction ratings for various denture functions, occlusal bite force, resistance to dislodgement, masticatory performance, perceived chewing ability, and oral health-related quality of life. Between-subjects comparisons among the three groups and within-subjects comparisons of the pre- and post-intervention measurements will be performed. Furthermore, a multiple regression analysis will be performed. The main analyses will be based on the intention-to-treat principle. A sample size of 100 subjects per group, including an assumed dropout rate of 10 %, will be required to achieve 80 % power with a 5 % alpha level. Discussion: This randomized clinical trial will provide information about denture adhesives to complete denture wearers, prosthodontic educators, and dentists in Japan. We believe this new evidence on denture adhesive use from Japan will aid dentists in their daily practice even in other countries