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Transforaminal lumbar interbody fusion with cortical bone trajectory screws versus traditional pedicle screws fixation: a study protocol of randomised controlled trial.

ABSTRACT: INTRODUCTION:Transforaminal lumbar interbody fusion (TLIF) has been widely used in the treatment of lumbar degenerative disc disorders and shows favourable clinical results. Recently, cortical bone trajectory (CBT) has become a new trajectory for screw insertion in the lumbar spine. Several biomechanical studies have demonstrated that the CBT technique achieves screw purchase and strength greater than the traditional method. Currently, the available data on the clinical effectiveness of the two performed surgeries, TLIF with CBT screws (CBT-TLIF) and TLIF with traditional pedicle screws (PS-TLIF), are insufficient. This is the first randomised study to compare CBT-TLIF against traditional PS fixation and will provide recommendations for treating patients with lumbar degenerative disc disorders. METHODS AND ANALYSIS:A blinded randomised controlled trial (blinding for the patient and statistician, rather than for the clinician and researcher) will be conducted. A total of 254 participants with lumbar disc degenerative disease who are candidates for TLIF surgery will be randomly allocated to either the CBT-TLIF group or the PS-TLIF group at a ratio of 1:1. The primary clinical outcome measures are the incidence of adjacent cranial facet joint violation, fusion rate and the screw loosening rate. Secondary clinical outcome measures are Visual Analogue Scale (VAS) of back pain, VAS of leg pain, Oswestry Disability Index, operative time, intraoperative blood loss and complications. These parameters will be evaluated on day 3, and then at 1, 3, 6, 12 and 24 months postoperatively. ETHICS AND DISSEMINATION:This study has been reviewed and approved by the Institutional Review Board of the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University (batch: 2017-03). The results will be presented in peer-reviewed journals and an international spine-related meeting after completion of the study. TRIAL REGISTRATION NUMBER:NCT03105167; Pre-results.

SUBMITTER: Feng Z

PROVIDER: S-EPMC5665262 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Transforaminal lumbar interbody fusion with cortical bone trajectory screws versus traditional pedicle screws fixation: a study protocol of randomised controlled trial.

Feng Zhenhua Z Li Xiaobin X Tang Qian Q Wang Chenggui C Zheng Wenhao W Zhang Hui H Wu Ai-Min AM Tian Naifeng N Wu Yaosen Y Ni Wenfei W

BMJ open 20171022 10

<h4>Introduction</h4>Transforaminal lumbar interbody fusion (TLIF) has been widely used in the treatment of lumbar degenerative disc disorders and shows favourable clinical results. Recently, cortical bone trajectory (CBT) has become a new trajectory for screw insertion in the lumbar spine. Several biomechanical studies have demonstrated that the CBT technique achieves screw purchase and strength greater than the traditional method. Currently, the available data on the clinical effectiveness of ...[more]

PMID: 29061616

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Project description:BackgroundTransforaminal lumbar interbody fusion (TLIF) has become one of the most widely used procedures for lumbar spinal disorders. However, it is still unclear whether TLIF with unilateral pedicle screw (PS) fixation is as effective as that with bilateral PS fixation. We performed a meta-analysis of the literatures and aimed to gain a better understanding of whether TLIF with unilateral PS fixation was safe and effective for lumbar diseases.Methodology/principal findingsWe systematically searched Ovid, Springer, and Medline databases for relevant randomized controlled trials (RCTs) that compared the clinical and radiological outcomes of unilateral versus bilateral PS fixation in TLIF. Risk of bias in included studies was assessed using the Cochrane Risk of Bias tool. We generated pooled risk ratios or weighted mean differences across studies. According to our predefined inclusion criteria, seven RCTs with a total of 441 patients were included in this study. Baseline characteristics were similar between the unilateral and bilateral groups. Our meta-analysis showed that no significant difference was detected between the two groups in terms of postoperative clinical function, fusion status, reoperation rate, complication rate, and hospital stay (p>0.05). Pooled estimates revealed that the unilateral group was associated with significantly reduced implant cost, operative time and blood loss (p<0.05).Conclusions/significancesOur meta-analysis suggested TLIF with unilateral PS fixation was as safe and effective as that with bilateral PS fixation for lumbar diseases in selected patients. Despite these findings, our meta-analysis was based on studies with small sample size and different study characteristics that might lead to the inconsistent results such as various functional outcomes among the included studies. Therefore, high-quality randomized controlled trials with larger sample size are also needed to further clarify these issues and to provide the long-term outcomes.

Project description:BackgroundThe previous studies agree that minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) has better function outcomes, less blood loss, and shorter hospital stay, when compared to open-TLIF. However, there are no significance differences on operative time, complication, and reoperation rate between the two procedures. This could be from less relative literatures and lower grade evidence. The further meta-analysis is needed with more and higher grade evidences to compare the above two TLIF procedures.MethodsProspective and retrospective studies that compared open-TLIF and MIS-TLIF were identified by searching the Medline, Embase, Web of Science, China National Knowledge Infrastructure, Wanfang, and VIP database (the literature search comprised Medical Subject Heading terms and key words or Emtree term). The retrieval time ranged from the date when the database was founded to January 2015. Pooled risk ratios (RR s) and weighted mean differences (WMDs) with 95% confidence intervals were calculated for the clinical outcomes and perioperative data.ResultsTwenty-four studies (n = 1967 patients) were included in this review (n = 951, open-TLIF, n = 1016, MIS-TLIF). MIS-TLIF was associated with a significant decrease in the visual analog score (VAS)-back pain score (WMD = -0.44; P = 0.001), Oswestry Disabilities Index (WMD = -1.57; P = 0.005), early ambulation (WMD = -1.77; P = 0.0001), less blood loss (WMD = -265.59; P < 0.00001), and a shorter hospital stay (WMD = -1.89; P < 0.0001). However, there were no significant differences in the fusion rate (RR = 0.99; P = 0.34), VAS-leg pain (WMD = -0.10; P = 0.26), complication rate (RR = 0.84; P = 0.35), operation time (WMD = -5.23; P = 0.82), or reoperation rate (RR = 0.73; P = 0.32).ConclusionsMIS-TLIF resulted in a similar fusion rate with better functional outcome, less blood loss, shorter ambulation, and hospital stay; furthermore, it did not increase the complication or reoperation rate based on the existing evidence.

Project description:Background The purpose of this study was to compare the safety and efficacy of unilateral vs. bilateral pedicle screw fixation (BPSF) for lumbar degenerative diseases. Methods Electronic databases including PubMed, Web of science, the Cochrane Library, Scopus, MEDLINE, EMBASE, EBSCO were searched by computer. The deadline was set for June 1, 2022. This study included all high-quality randomized controlled trials (RCTs), prospective clinical controlled studies (PRO), and retrospective studies (Retro) that compared unilateral and bilateral pedicle screw fixation in the treatment of lumbar degenerative diseases. Revman5.3 software was used for meta-analysis after two researchers independently screened the literature, extracted data, and assessed the risk of bias in the study. Results Fourteen studies with a total of 1,086 patients were included. Compared with BPSF, unilateral pedicle screw fixation (UPSF) has shorter operation time and hospital time, and less blood loss and operation cost, operation time [SMD = −1.75, 95% CI (−2.46 to −1.03), P < 0.00001], hospital time [SMD = −1.10, 95% CI (−1.97 to −0.22), P = 0.01], Blood loss [SMD = −1.62, 95% CI (−2.42 to −0.82), P < 0.0001], operation cost [SMD = −14.03, 95% CI (−20.08 to −7.98), P < 0.00001], the ODI after bilateral pedicle screw fixation was lower, and the degree of lumbar dysfunction was lighter, [SMD = 0.19, 95% CI (0.05–0.33), P = 0.007], better fusion effect, fusion rate [RR=0.95, 95% CI (0.91–1.00), P = 0.04]. VAS-Low back pain [SMD = 0.07, 95% CI (−0.07–0.20), P = 0.35], VAS-Leg pain [SMD = 0.18, 95% CI (−0.00–0.36), P = 0.05], SF-36 [SMD = 0.00, 95% CI (−0.30–0.30), P = 1.00], complications rate [RR = 0.94, 95% CI (0.9154–1.63), P = 0.82], the overall difference was not statistically significant. Conclusions Currently limited evidence suggests that UPSF significantly reduces blood loss, significantly shortens the operative time and hospital stay, and reduces blood loss and costs. After BPSF, the ODI was lower, the degree of lumbar spine dysfunction was lower, and the fusion rate was significantly higher. The VAS, SF-36, and complications scores of the two groups were comparable, and there was no significant clinical difference.

Project description:PurposeMinimally invasive transforaminal lumbar interbody fusion (MI-TLIF) is increasingly popular for the surgical treatment of degenerative lumbar disc diseases. The constructs intended for segmental stability are varied in MI-TLIF. We adopted finite element (FE) analysis to compare the stability after different construct fixations using interbody cage with posterior pedicle screw-rod or pedicle screw-plate instrumentation system.MethodsA L3-S1 FE model was modified to simulate decompression and fusion at L4-L5 segment. Fixation modes included unilateral plate (UP), unilateral rod (UR), bilateral plate (BP), bilateral rod (BR) and UP+UR fixation. The inferior surface of the S1 vertebra remained immobilized throughout the load simulation, and a bending moment of 7.5 Nm with 400N pre-load was applied on the L3 vertebra to recreate flexion, extension, lateral bending, and axial rotation. Range of motion (ROM) and Von Mises stress were evaluated for intact and instrumentation models in all loading planes.ResultsAll reconstructive conditions displayed decreased motion at L4-L5. The pedicle screw-plate system offered equal ROM to pedicle screw-rod system in unilateral or bilateral fixation modes respectively. Pedicle screw stresses for plate system were 2.2 times greater than those for rod system in left lateral bending under unilateral fixation. Stresses for plate were 3.1 times greater than those for rod in right axial rotation under bilateral fixation. Stresses on intervertebral graft for plate system were similar to rod system in unilateral and bilateral fixation modes respectively. Increased ROM and posterior instrumentation stresses were observed in all loading modes with unilateral fixation compared with bilateral fixation in both systems.ConclusionsTransforaminal lumbar interbody fusion augmentation with pedicle screw-plate system fixation increases fusion construct stability equally to the pedicle screw-rod system. Increased posterior instrumentation stresses are observed in all loading modes with plate fixation, and bilateral fixation could reduce stress concentration.

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Transforaminal lumbar interbody fusion with cortical bone trajectory screws versus traditional pedicle screws fixation: a study protocol of randomised controlled trial.

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Transforaminal lumbar interbody fusion with cortical bone trajectory screws versus traditional pedicle screws fixation: a study protocol of randomised controlled trial.

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