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373 result(s) for "Spinal Fusion - standards"
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Prospective, Randomized, Double-Blind Clinical Study Evaluating the Correlation of Clinical Outcomes and Cervical Sagittal Alignment
Abstract BACKGROUND: Sagittal alignment of the cervical spine has received increased attention in the literature as an important determinant of clinical outcomes after anterior cervical diskectomy and fusion. Surgeons use parallel or lordotically fashioned grafts depending on preference or simple availability. OBJECTIVE: To quantitatively assess and compare cervical sagittal alignment and clinical outcome when lordotic or parallel allografts were used for fusion. METHODS: A prospective, randomized, double-blind clinical study that enrolled 122 patients was performed. The mean follow-up was 37.5 months (range, 12-54 months). RESULTS: The mean postoperative cervical sagittal alignment was 19° (range, −7°-36°) and 18° (range, −7°-37°) in the lordotic and parallel graft patient groups, respectively. The mean segmental sagittal alignment was 6° (range, −4°-19°) and 7° (range, −3°-19°) in the lordotic and parallel graft patient groups, respectively. There were no statistically significant differences in clinical outcome scores between the lordotic and parallel graft patient groups. However, patients who had maintained or improved segmental sagittal alignment, regardless of graft type, achieved a higher degree of improvement in Short Form-36 Physical Component Summary and Neck Disability Index scores. This was statistically significant (P < .038). CONCLUSION: The use of lordotically shaped allografts does not increase cervical/segmental sagittal alignment or improve clinical outcomes. Maintaining a consistent segmental sagittal alignment or increasing segmental lordosis was related to a higher degree of improvement in clinical outcomes.
A Novel Inextensible Endoscopic Tube Versus Traditional Extensible Retractor System in Single-Level Minimally Invasive Transforaminal Lumbar Interbody Fusion: A Prospective Observation Study
Currently, various retractor systems are widely used for access to the lumbar spine in minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF). Nevertheless, studies concerning the comparison of extensible retractor and inextensible tube systems are quite rare. This article was to compare perioperative characteristics, clinical outcomes, and multifidus muscle injury of obconic inextensible tube versus extensible retractor system for single-level MIS-TLIF. A prospective observational study on 91 patients with a mean follow-up of 20.0 ± 4.1 months. This study was conducted by a university-affiliated hospital in a major Chinese city. From April 2015 to May 2016, 91 consecutive patients who underwent MIS-TLIF procedure using an obconic inextensible endoscopic tube or extensible retractor system were enrolled in this study. Operation parameters such as incision length, blood loss, postoperative drainage volume, surgical time, analgesic use rate, time to ambulation, and postoperative hospitalization days were evaluated. The concentration of white blood cells, interleukin-6, interleukin-8, tumor necrosis factor alpha, and creatine phosphokinase (CPK)-MM of the enrolled patients were measured for postoperative traumatic stress and muscle injury. Multifidus muscle edema and atrophy were evaluated by T2-weighted magnetic resonance imaging (MRI) at 3 different time points (preoperative, postoperative, and 1-year follow-up). Clinical outcomes such as Visual Analog Scale (VAS) score, Japanese Orthopedic Association (JOA) score, Oswestry Disability Index (ODI) score, fusion rates, and MacNab criteria were assessed for patients' symptoms. In terms of baseline characteristics, the 2 groups were similar regarding sample size, gender, age, symptoms duration, operation level, body mass index, physical examination, and all the clinical outcomes measures (P > 0.05). Perioperative analysis showed that the inextensible group had comparative incision length, blood loss, operation time, time to ambulation, and postoperative hospitalization (P > 0.05). The inextensible tubular group had less postoperative drainage volume and analgesic use rate (P < 0.05). The concentration level of CPK-MM and c-reactive protein (CRP) was lower in the inextensible tubular group compared with the extensible retractor group.No significant difference was found between the 2 groups regarding MRI T2 signal intensity ratio of multifidus muscle at the immediate postoperative period. The MRI T2 signal intensity ratio of multifidus muscle was lower in the inextensible tubular group than the extensible retractor group at the 1-year follow-up period. The VAS scores for low back pain and leg pain improved significantly in both groups after surgery, as did the JOA and ODI scores. However, there were no significant differences between the 2 groups regarding the preoperative and final follow-up VAS, JOA, and ODI scores, fusion rates, and the distribution of the MacNab criteria. This was not a randomized controlled trail, which could provide more evidence-based medicine conclusions. The obconic inextensible endoscopic tube system via the transforaminal approach for lumbar interbody fusion is a safe and sufficient technique. When compared with the extensible retractor system, it has comparable clinical outcomes, with additional significant benefits of less postoperative drainage volume and analgesic use rate, less multifidus muscle injury in terms of lower CPK-MM levels at immediate postoperative period, less change in CRP, and less change in MRI T2 signal intensity ratio of multifidus muscles at 1-year follow-up. Minimally invasive, endoscopic, lumbar interbody fusion, tubular, multifidus muscle.
Transforaminal lumbar interbody fusion vs. posterolateral instrumented fusion: cost-utility evaluation along side an RCT with a 2-year follow-up
Purpose Long-lasting low back pain is an increasing problem, and for some patients surgery is the final option for improvement. Several techniques for spinal fusion are available and the optimal technique remains uncertain. The objective of this study was to assess the cost-effectiveness and cost-utility of transforaminal lumbar interbody fusion (TLIF) compared to posterolateral instrumented fusion (PLF) from the societal perspective. Methods 100 Patients were randomized to TLIF or PLF (51/49) and followed for 2 years. Cost data were acquired from national registers, and outcomes were measured using the Oswestry Disability Index and SF-6D questionnaires. Conventional cost-effectiveness methodology was employed to estimate net benefit and to illustrate cost-effectiveness acceptability curves. The statistical analysis was based on means and bootstrapped confidence intervals. Results Results showed no statistically significant difference in either cost or effects although a tendency for the TLIF regimen being more costly on bed days (€2,554) and production loss (€1,915) was observed. The probability that TLIF would be cost-effective did not exceed 30 % for any threshold of willingness to pay per quality-adjusted life year. Sensitivity analysis was conducted and supported the statistical model for handling of missing data. Conclusion TLIF does not seem to be a relevant alternative to PLF from a socioeconomic, societal point of view.
Evaluation of efficacy of a new hybrid fusion device: a randomized, two-centre controlled trial
Background The 360° fusion of lumbar segments is a common and well-researched therapy to treat various diseases of the spine. But it changes the biomechanics of the spine and may cause adjacent segment disease (ASD). Among the many techniques developed to avoid this complication, one appears promising. It combines a rigid fusion with a flexible pedicle screw system (hybrid instrumentation, “topping off”). However, its clinical significance is still uncertain due to the lack of conclusive data. Methods/Design The study is a randomized, therapy-controlled, two-centre trial conducted in a clinical setting at two university hospitals. If they meet the criteria, outpatients presenting with degenerative disc disease, facet joint arthrosis or spondylolisthesis will be included in the study and randomized into two groups: a control group undergoing conventional fusion surgery (PLIF - posterior lumbar intervertebral fusion), and an intervention group undergoing fusion surgery using a new flexible pedicle screw system (PLIF + “topping off”), which was brought on the market in 2013. Follow-up examination will take place immediately after surgery, after 6 weeks and after 6, 12, 24 and 36 months. An ongoing assessment will be performed every year. Outcome measurements will include quality of life and pain assessments using validated questionnaires (ODI - Ostwestry Disability Index, SF-36™ - Short Form Health Survey 36, COMI - Core Outcome Measure Index). In addition, clinical and radiologic ASD, sagittal balance parameters and duration of work disability will be assessed. Inpatient and 6-month mortality, surgery-related data (e.g., intraoperative complications, blood loss, length of incision, surgical duration), postoperative complications (e.g. implant failure), adverse events, and serious adverse events will be monitored and documented throughout the study. Discussion New hybrid “topping off” systems might improve the outcome of lumbar spine fusion. But to date, there is a serious lack of and a great need of convincing data on safety or efficacy, including benefits and harms to the patients, of these systems. Health care providers are particularly interested in such data as these implants are much more expensive than conventional implants. In such a case, randomized clinical trials are the best way to evaluate benefits and risks. Trial registration NCT01852526
Resource Utilization in Adolescent Idiopathic Scoliosis Surgery: Is There Opportunity for Standardization?
IntroductionRecent healthcare reforms have raised the importance of cost and value in the management of disease. Value is a function of benefit and cost. Understanding variability in resources utilized by individual surgeons to achieve similar outcomes may provide an opportunity for cutting costs though greater standardization. The purpose of this study is to evaluate differences in use of implants and hospital resources among surgeons performing adolescent idiopathic scoliosis (AIS) surgery.MethodsA multicenter prospective AIS operative database was queried. Patients were matched for Lenke curve type and curve magnitude, resulting in 5 surgeons and 35 matched groups (N = 175). Mean patient age was 14.9 years and curve magnitude 50°. Parameters of interest were compared between surgeons via ANOVA and Bonferroni pairwise comparison.ResultsThere was no significant difference in percentage curve correction or levels fused between surgeons. Significant differences between surgeons were found for percentage posterior approach, operative time, length of stay (LOS), estimated blood loss (EBL), cell saver transfused, rod material, screw density, number of screws, use of antifibrinolytics, and cessation of intravenous analgesics. Despite differences in EBL and cell saver transfused, there were no differences in allogenic blood (blood bank) use.ConclusionSignificant variability in resource utilization was noted between surgeons performing AIS operations, although radiographic results were uniform. Standardization of resource utilization and cost containment opportunities include implant usage, rod material, LOS, and transition to oral analgesics, as these factors are the largest contributors to cost in AIS surgery.
Degenerative spondylolisthesis of the cervical spine — symptoms and surgical strategies depending on disease progress
Degenerative spondylolisthesis of the cervical spine is rare. Patients show signs of progredient myelopathy, radiculopathy and pain. Treatment strategies include ventral, dorsal and combined fusion techniques with or without repositioning and decompression. In this study, we present 16 patients with degenerative cervical spondylolisthesis. The leading symptom was severe myelopathy in 8 patients, radiculomyelopathy in 5 patients and neck pain in 3 patients. However, neck pain was the initial symptom in all the patients and decreased when neurological symptoms became more evident. Radiographic examinations included plain radiography, MRI, CT, myelography and lateral tomography. Spondylolisthesis was located five times at level C3/4, C4/5 and C5/6. In three cases spondylolisthesis was located at level C7/T1. There were two patients with spondylolisthesis on two levels. Instability could be demonstrated by flexion/extension radiography in five cases. Patients were divided into three groups according to a newly introduced classification system. The surgical approach corresponded to this classification. In ten patients the spondylolisthesis could be corrected by extension and positioning, so discectomy and fusion on one or two levels with cage, plate and screws was sufficient. In five cases a corpectomy was necessary due to severe spondylosis. In one case a combined approach with dorsal decompression and release followed by ventral fusion was applied due to additional dorsal spinal cord compression. The follow-up period was 6-52 months. After surgery, none of the patients showed any signs of neurological deterioration. In all cases, a stable fusion was achieved with no signs of instability on flexion/extension radiographs. Neurological improvement was seen in 6 of 8 patients with myelopathy and 4 of 5 patients with radiculomyelopathy. The others showed stable disease. Pain relief was seen in all patients who complained of pain preoperatively. The aims of treatment for cervical spondylolisthesis are spinal cord decompression (ventral, dorsal or both), correction and fusion. The used procedure should depend on the severity of the cervical deformity, degree and side of the spinal cord compression, and the possibility of correction by extension and positioning.
The Association of Preoperative Opioid Usage With Patient-Reported Outcomes, Adverse Events, and Return to Work After Lumbar Fusion: Analysis From the Michigan Spine Surgery Improvement Collaborative (MSSIC)
Abstract BACKGROUND It is important to delineate the relationship between opioid use and spine surgery outcomes. OBJECTIVE To determine the association between preoperative opioid usage and postoperative adverse events, patient satisfaction, return to work, and improvement in Oswestry Disability Index (ODI) in patients undergoing lumbar fusion procedures by using 2-yr data from a prospective spine registry. METHODS Preoperative opioid chronicity from 8693 lumbar fusion patients was defined as opioid-naïve (no usage), new users (<6 wk), short-term users (6 wk-3 mo), intermediate-term users (3-6 mo), and chronic users (>6 mo). Multivariate generalized estimating equation models were constructed. RESULTS All comparisons were to opioid-naïve patients. Chronic opioid users showed less satisfaction with their procedure at 90 d (Relative Risk (RR) 0.95, P = .001), 1 yr (RR 0.89, P = .001), and 2 yr (RR 0.89, P = .005). New opioid users were more likely to show improvement in ODI at 90 d (RR 1.25, P < .001), 1 yr (RR 1.17, P < .001), and 2 yr (RR 1.19, P = .002). Short-term opioid users were more likely to show ODI improvement at 90 d (RR 1.25, P < .001). Chronic opioid users were less likely to show ODI improvement at 90 d (RR 0.90, P = .004), 1 yr (RR 0.85, P < .001), and 2 yr (RR 0.80, P = .003). Chronic opioid users were less likely to return to work at 90 d (RR 0.80, P < .001). CONCLUSION In lumbar fusion patients and when compared to opioid-naïve patients, new opioid users were more likely and chronic opioid users less likely to have improved ODI scores 2 yr after surgery. Chronic opioid users are less likely to be satisfied with their procedure 2 yr after surgery and less likely to return to work at 90 d. Preoperative opioid counseling is advised.
A multicenter study on accuracy and complications of freehand placement of cervical pedicle screws under lateral fluoroscopy in different pathological conditions: CT-based evaluation of more than 1,000 screws
Purpose To conduct a retrospective multicenter study to investigate the accuracy of pedicle screw (PS) placement in the cervical spine by freehand technique and the related complications in various pathological conditions including trauma, rheumatoid arthritis, degenerative conditions and others. Methods 283 patients with 1,065 PSs in the cervical spine who were treated at eight spine centers and finished postoperative CT scan were enrolled. The numbers of placed PSs were 608 for trauma, 180 for rheumatoid arthritis (RA), 199 for spondylosis, and 78 for others. Malposition grades on CT image in the axial plane were defined as grade 0 (G-0) correct placement, grade 1 (G-1): malposition by less than half screw diameter, grade 2 (G-2): malposition by more than half screw diameter. The direction of malposition was classified into four categories: medial, lateral, superior and inferior. Results Overall malposition rate was 14.8 % (9.6 % in G-1 and 5.3 % in G-2). The highest malposition rate was 26.7 % for RA, followed by 16.6 % for spondylosis, and 11.2 % for trauma. The malposition rate for RA was significantly higher than those for other pathologies. 79.7 % of the malpositioned screws were placed laterally. Though intraoperative vertebral artery injury was observed in two patients with RA, there were no serious complications during a minimal 2-year follow-up. Conclusions Malposition rate of PS placement in the cervical spine by freehand technique was high in rheumatoid patients even when being performed by experienced spine surgeons. Any guidance tools including navigation systems are recommended for placement of cervical PSs in patients with RA.
Anterior cervical discectomy and fusion with stand-alone anchored cages versus posterior laminectomy and fusion for four-level cervical spondylotic myelopathy: a retrospective study with 2-year follow-up
Background The optimal treatment for multi-level cervical spondylotic myelopathy (CSM) remains controversial. Posterior approach is most commonly used, but complicated with insufficient decompression and postoperative axial neck pain. The anterior approach is effective in neural decompression with less surgical trauma. However, the profile of the plate or the possible construct failure may cause dysphagia after surgery. Recently, anterior cervical discectomy and fusion (ACDF) with self-anchored cage is reported to have a superior result over ACDF with anterior plates and screws in three-level CSM. The purpose of the study is to compare the clinical and radiological outcomes of ACDF using stand-alone anchored cages to that of laminectomy with fusion (LF) for treating four-level CSM. Methods Twenty-six patients underwent four-level ACDF (Group A) and 32 patients with four-level LF (Group B) were retrospectively reviewed and followed-up for 24 months. Clinical efficacy was evaluated by comparing pre- and post-operative Japanese Orthopedic Association (JOA) and Neck Disability Index (NDI) scores. Operative time, blood loss, fusion, lordosis change and complications were evaluated. Results There was significantly less blood loss in Group A (163.4 ± 72.1 ml) than Group B (241.0 ± 112.3 ml) ( P  < 0.05). Both groups demonstrated significant improvements in JOA and NDI scores after surgery with similar operative time. Improvements in cervical lordosis and fused segment lordosis were more pronounced in Group A (11.3 ± 5.9°, 9.7 ± 5.3°) than Group B (5.8 ± 4.6°, 5.5 ± 4.5°) ( P  < 0.05). Loss of lordosis in the cervical spine and fused segment was more prominent in Group A (11.7 ± 2.2°, 6.7 ± 3.2°) than Group B (7.5 ± 3.8°, 3.7 ± 3.4°) ( P  < 0.05) at the final follow-up. Complication rate in Group A and Group B was 57.69 and 18.75%, respectively. Conclusions ACDF using a stand-alone anchored cage showed similar clinical results to LF for the treatment of four-level CSM, with better lordosis correction and less blood loss. However, ACDF was associated with more loss of lordosis after surgery and more non-unions.
Changes in lumbar lordosis and predicted minimum 5-year surgical outcomes after short-segment transforaminal lumbar interbody fusion
Although most patients who undergo transforaminal lumbar interbody fusion (TLIF) show favorable surgical results, some still have unfavorable results for various reasons. This study aimed to investigate the influence of differences in lumbar lordosis (LL) between the standing and supine positions (DiLL: supine LL–standing LL) on minimum 5-year surgical outcomes after short-segment TLIF. Ninety-one patients with lumbar degenerative disease who underwent short-segment TLIF (1–2 levels) were categorized based on preoperative differences in LL as DiLL (+) and DiLL (−). Comparison and correlation analyses were performed. The incidence of adjacent segment disease (ASD) by radiology (R-ASD) and symptomatic ASD (S-ASD), bony fusion rates, and pre- and postoperative clinical scores (visual analog scale [VAS]; Japanese Orthopaedic Association [JOA] score; Oswestry disability index (ODI); and Nakai’s score) were evaluated. Postoperatively, VAS for low back pain (LBP) in the sitting position, JOA scores for LBP, lower leg pain, intermittent claudication, ODI, and Nakai’s score were significantly worse in the DiLL (+) group than in the DiLL (−) group. DiLL values were significantly correlated with VAS for LBP, ODI, and Nakai’s score, postoperatively. Positive DiLL values were associated with poorer postoperative outcomes. DiLL is a simple and useful method for predicting mid-term outcomes after TLIF.