scholarly journals A protocol of a randomized controlled multicenter trial for surgical treatment of lumbar spondylolisthesis: the Lumbar Interbody Fusion Trial (LIFT)

2016 ◽  
Vol 17 (1) ◽  
Author(s):  
Suzanne L. de Kunder ◽  
Kim Rijkers ◽  
Sander M. J. van Kuijk ◽  
Silvia M. A. A. Evers ◽  
Rob A. de Bie ◽  
...  
Keyword(s):  
Surgical Treatment ◽  
Interbody Fusion ◽  
Multicenter Trial ◽  
Lumbar Interbody Fusion ◽  
Randomized Controlled ◽  
Lumbar Spondylolisthesis

scholarly journals Posterolateral Fusion Versus Posterior Lumbar Interbody Fusion: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2021 ◽  
pp. 219256822110164
Author(s):  
Elsayed Said ◽  
Mohamed E. Abdel-Wanis ◽  
Mohamed Ameen ◽  
Ali A. Sayed ◽  
Khaled H. Mosallam ◽  
...  
Keyword(s):  
Systematic Review ◽  
Blood Loss ◽  
Interbody Fusion ◽  
Revision Rate ◽  
Meta Analysis ◽  
Posterior Lumbar Interbody Fusion ◽  
Operation Time ◽  
Controlled Trials ◽  
Lumbar Interbody Fusion ◽  
Randomized Controlled

Study Design: Systematic review and meta-analysis. Objectives: Arthrodesis has been a valid treatment option for spinal diseases, including spondylolisthesis and lumbar spinal stenosis. Posterolateral and posterior lumbar interbody fusion are amongst the most used fusion techniques. Previous reports comparing both methods have been contradictory. Thus, we conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to establish substantial evidence on which fusion method would achieve better outcomes. Methods: Major databases including PubMed, Embase, Web of Science and CENTRAL were searched to identify studies comparing outcomes of interest between posterolateral fusion (PLF) and posterior lumbar interbody fusion (PLIF). We extracted data on clinical outcome, complication rate, revision rate, fusion rate, operation time, and blood loss. We calculated the mean differences (MDs) for continuous data with 95% confidence intervals (CIs) for each outcome and the odds ratio with 95% confidence intervals (CIs) for binary outcomes. P < 0.05 was considered significant. Results: We retrieved 8 studies meeting our inclusion criteria, with a total of 616 patients (308 PLF, 308 PLIF). The results of our analysis revealed that patients who underwent PLIF had significantly higher fusion rates. No statistically significant difference was identified in terms of clinical outcomes, complication rates, revision rates, operation time or blood loss. Conclusions: This systematic review and meta-analysis provide a comparison between PLF and PLIF based on RCTs. Although PLIF had higher fusion rates, both fusion methods achieve similar clinical outcomes with equal complication rate, revision rate, operation time and blood loss at 1-year minimum follow-up.

The SNAP Trial: 2-Year Results of a Double-Blind Multicenter Randomized Controlled Trial of a Silicon Nitride Versus a PEEK Cage in Patients After Lumbar Fusion Surgery

2021 ◽  
pp. 219256822098547
Author(s):  
R. F. M. R. Kersten ◽  
F. C. Öner ◽  
M. P. Arts ◽  
M. Mitroiu ◽  
K. C. B. Roes ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Silicon Nitride ◽  
Interbody Fusion ◽  
Controlled Trial ◽  
Segmental Motion ◽  
Lumbar Interbody Fusion ◽  
Double Blind ◽  
Randomized Controlled ◽  
Disability Questionnaire

Study Design: Randomized controlled trial. Objectives: Lumbar interbody fusion with cages is performed to provide vertebral stability, restore alignment, and maintain disc and foraminal height. Polyetheretherketone (PEEK) is commonly used. Silicon nitride (Si3N4) is an alternative material with good osteointegrative properties. This study was designed to assess if Si3N4 cages perform similar to PEEK. Methods: A non-inferiority double-blind multicenter RCT was designed. Patients presenting with chronic low-back pain with or without leg pain were included. Single- or double-level instrumented transforaminal lumbar interbody fusion (TLIF) using an oblique PEEK or Si3N4 cage was performed. The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ). The non-inferiority margin for the RMDQ was 2.6 points on a scale of 24. Secondary outcomes included the Oswestry Disability Questionnaire (ODI), Visual Analogue Scales (VAS), SF-36 Physical Function, patient and surgeon Likert scores, radiographic evaluations for subsidence, segmental motion, and fusion. Follow-up was planned at 3, 6, 12, and 24-months. Results: Ninety-two patients were randomized ( i.e. 48 to PEEK and 44 to Si3N4). Both groups showed good clinical improvements on the RMDQ scores of up to 5-8 points during follow-up. No statistically significant differences were observed in clinical and radiographic outcomes. Mean operative time and blood loss were statistically significantly higher for the Si3N4 cohort. Although not statistically significant, there was a higher incidence of complications and revisions associated with the Si3N4 cage. Conclusions: There was insufficient evidence to conclude that Si3N4 was non-inferior to PEEK.

scholarly journals Comparison of (Partial) economic evaluations of transforaminal lumbar interbody fusion (TLIF) versus Posterior lumbar interbody fusion (PLIF) in adults with lumbar spondylolisthesis: A systematic review

PLoS ONE ◽  
2021 ◽  
Vol 16 (2) ◽  
pp. e0245963
Author(s):  
Inge J. M. H. Caelers ◽  
Suzanne L. de Kunder ◽  
Kim Rijkers ◽  
Wouter L. W. van Hemert ◽  
Rob A. de Bie ◽  
...  
Keyword(s):  
Systematic Review ◽  
Health Care ◽  
Cost Effectiveness ◽  
Interbody Fusion ◽  
Posterior Lumbar Interbody Fusion ◽  
Transforaminal Lumbar Interbody Fusion ◽  
Economic Evaluations ◽  
Lumbar Interbody Fusion ◽  
Lumbar Spondylolisthesis

Introduction The demand for spinal fusion surgery has increased over the last decades. Health care providers should take costs and cost-effectiveness of these surgeries into account. Open transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF) are two widely used techniques for spinal fusion. Earlier research revealed that TLIF is associated with less blood loss, shorter surgical time and sometimes shorter length of hospital stay, while effectiveness of both techniques on back and/or leg pain are equal. Therefore, TLIF could result in lower costs and be more cost-effective than PLIF. This is the first systematic review comparing direct and indirect (partial) economic evaluations of TLIF with PLIF in adults with lumbar spondylolisthesis. Furthermore, methodological quality of included studies was assessed. Methods Searches were conducted in eight databases for reporting on eligibility criteria; TLIF or PLIF, lumbar spondylolisthesis or lumbar instability, and cost. Costs were converted to United States Dollars with reference year 2020. Study quality was assessed using the bias assessment tool of the Cochrane Handbook for Systematic Reviews of Interventions, the Level of Evidence guidelines of the Oxford Centre for Evidence-based Medicine and the Consensus Health Economic Criteria (CHEC) list. Results Of a total of 693 studies, 16 studies were included. Comparison of TLIF and PLIF could only be made indirectly, since no study compared TLIF and PLIF directly. There was a large heterogeneity in health care and societal perspective costs due to different in-, and exclusion criteria, baseline characteristics and the use of costs or charges in calculations. Health care perspective costs, calculated with hospital costs, ranged from $15,867-$43,217 in TLIF-studies and $32,662 in one PLIF-study. Calculated with hospital charges, it ranged from $8,964-$51,469 in TLIF-studies and $21,838-$93,609 in two PLIF-studies. Societal perspective costs and cost-effectiveness, only mentioned in TLIF-studies, ranged from $5,702/QALY-$48,538/QALY and $50,092/QALY-$90,977/QALY, respectively. Overall quality of studies was low. Conclusions This systematic review shows that TLIF and PLIF are expensive techniques. Moreover, firm conclusions about the preferable technique, based on (partial) economic evaluations, cannot be drawn due to limited studies and heterogeneity. Randomized prospective trials and full economical evaluations with direct TLIF and PLIF comparison are needed to obtain high levels of evidence. Furthermore, development of guidelines to perform adequate economic evaluations, specified for the field of interest, will be useful to minimize heterogeneity and maximize transferability of results. Trial registration Prospero-database registration number: CRD42020196869.

A Comparison of Minimally Invasive and Open Transforaminal Lumbar Interbody Fusion for Grade 1 Degenerative Lumbar Spondylolisthesis: An Analysis of the Prospective Quality Outcomes Database

Neurosurgery ◽  
2020 ◽  
Vol 87 (3) ◽  
pp. 555-562 ◽  
Author(s):  
Andrew K Chan ◽  
Erica F Bisson ◽  
Mohamad Bydon ◽  
Kevin T Foley ◽  
Steven D Glassman ◽  
...  
Keyword(s):  
Blood Loss ◽  
Minimally Invasive ◽  
Sample Size ◽  
Interbody Fusion ◽  
Transforaminal Lumbar Interbody Fusion ◽  
Small Sample ◽  
Lumbar Interbody Fusion ◽  
Quality Outcomes ◽  
Degenerative Lumbar Spondylolisthesis ◽  
Lumbar Spondylolisthesis

ABSTRACT BACKGROUND It remains unclear if minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) is comparable to traditional, open TLIF because of the limitations of the prior small-sample-size, single-center studies reporting comparative effectiveness. OBJECTIVE To compare MI-TLIF to traditional, open TLIF for grade 1 degenerative lumbar spondylolisthesis in the largest study to date by sample size. METHODS We utilized the prospective Quality Outcomes Database registry and queried patients with grade 1 degenerative lumbar spondylolisthesis who underwent single-segment surgery with MI- or open TLIF methods. Outcomes were compared 24 mo postoperatively. RESULTS A total of 297 patients were included: 72 (24.2%) MI-TLIF and 225 (75.8%) open TLIF. MI-TLIF surgeries had lower mean body mass indexes (29.5 ± 5.1 vs 31.3 ± 7.0, P = .0497) and more worker's compensation cases (11.1% vs 1.3%, P &lt; .001) but were otherwise similar. MI-TLIF had less blood loss (108.8 ± 85.6 vs 299.6 ± 242.2 mL, P &lt; .001), longer operations (228.2 ± 111.5 vs 189.6 ± 66.5 min, P &lt; .001), and a higher return-to-work (RTW) rate (100% vs 80%, P = .02). Both cohorts improved significantly from baseline for 24-mo Oswestry Disability Index (ODI), Numeric Rating Scale back pain (NRS-BP), NRS leg pain (NRS-LP), and Euro-Qol-5 dimension (EQ-5D) (P &gt; .001). In multivariable adjusted analyses, MI-TLIF was associated with lower ODI (β = −4.7; 95% CI = −9.3 to −0.04; P = .048), higher EQ-5D (β = 0.06; 95% CI = 0.01-0.11; P = .02), and higher satisfaction (odds ratio for North American Spine Society [NASS] 1/2 = 3.9; 95% CI = 1.4-14.3; P = .02). Though trends favoring MI-TLIF were evident for NRS-BP (P = .06), NRS-LP (P = .07), and reoperation rate (P = .13), these results did not reach statistical significance. CONCLUSION For single-level grade 1 degenerative lumbar spondylolisthesis, MI-TLIF was associated with less disability, higher quality of life, and higher patient satisfaction compared with traditional, open TLIF. MI-TLIF was associated with higher rates of RTW, less blood loss, but longer operative times. Though we utilized multivariable adjusted analyses, these findings may be susceptible to selection bias.

Sign in / Sign up

Export Citation Format

Share Document