Results of instrumented posterolateral fusion in failed back surgery.
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ABSTRACT:
SUBMITTER: Badawy WS
PROVIDER: S-EPMC2532129 | biostudies-other | 2006 Aug
REPOSITORIES: biostudies-other
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Project description:The purpose of this study was to evaluate the long-term clinical and radiographic outcomes of posterolateral lumbar fusion for lumbar stenosis cases requiring bilateral facetectomy in conjunction with a laminectomy. The authors evaluated 34 consecutive patients who had undergone a lumbar laminectomy, bilateral partial facetectomy, and posterolateral fusion at a single institution between 1981 and 1996. They included 25 men and 9 women with a mean age of 42 years (range, 27-57 years). Twenty-three cases were instrumented and 11 were noninstrumented. Mean follow-up was 21 years (range, 15-29 years). Outcomes evaluated included reoperation rate, clinical outcomes evaluated by the Oswestry Disability Index (ODI) score, radiographic evaluations of adjacent segmental degeneration (ASD) and lumbar lordosis, and contributing demographic factors to disease progression. At final follow-up, 17 of the 34 patients had undergone reoperation (43% of the instrumented group and 64% of the noninstrumented group). There were no differences in the reoperation rate or ODI improvement between the instrumented and noninstrumented groups (P>.05). Female patients required more revisions, had less ODI improvement, had greater postoperative ASD, and had less maintenance of their postoperative lumbar lordosis. There was no difference in maintenance of postoperative lumbar lordosis or ASD between the instrumented and noninstrumented groups. Instrumentation did not improve revision rates, clinical outcomes, or radiographic outcomes in laminectomies requiring contemporaneous facetectomies.
| S-EPMC5561727 | biostudies-other
Project description:STUDY DESIGN:Two-year clinical and radiographic follow-up of a double-blind, multicenter, randomized, intra-patient controlled, non-inferiority trial comparing a bone graft substitute (AttraX Putty) with autograft in instrumented posterolateral fusion (PLF) surgery. OBJECTIVES:The aim of this study was to compare PLF rates between 1 and 2 years of follow-up and between graft types, and to explore the role of bone grafting based on the location of the PLF mass. SUMMARY OF BACKGROUND DATA:There are indications that bony fusion proceeds over time, but it is unknown to what extent this can be related to bone grafting. METHODS:A total of 100 adult patients underwent a primary, single- or multilevel, thoracolumbar PLF. After instrumentation and preparation for grafting, the randomized allocation side of AttraX Putty was disclosed. The contralateral posterolateral gutters were grafted with autograft. At 1-year follow-up, and in case of no fusion at 2 years, the fusion status of both sides of each segment was blindly assessed on CT scans. Intertransverse and facet fusion were scored separately. Difference in fusion rates after 1 and 2 years and between grafts were analyzed with a Generalized Estimating Equations (GEE) model (P?<?0.05). RESULTS:The 2-year PLF rate (66 patients) was 70% at the AttraX Putty and 68% at the autograft side, compared to 55% and 52% after 1 year (87 patients). GEE analysis demonstrated a significant increase for both conditions (odds ratio 2.0, 95% confidence interval 1.5-2.7, P?<?0.001), but no difference between the grafts (P?=?0.595). Ongoing bone formation was only observed between the facet joints. CONCLUSION:This intra-patient controlled trial demonstrated a significant increase in PLF rate between 1 and 2 years after instrumented thoracolumbar fusion, but no difference between AttraX Putty and autograft. Based on the location of the PLF mass, this increase is most likely the result of immobilization instead of grafting. LEVEL OF EVIDENCE:1.
| S-EPMC7515483 | biostudies-literature
Project description:The failed back surgery syndrome (FBSS) is a severe, long-lasting, disabling and relatively frequent (5-10%) complication of lumbosacral spine surgery. Wrong level surgery, inadequate surgical techniques, vertebral instability, recurrent disc herniation, and lumbosacral fibrosis are the most frequent causes of FBSS. The results after repeated surgery on recurrent disc herniations are comparable to those after the first intervention, whereas repeated surgery for fibrosis gives only 30-35% success rates, and 15-20% of the patients report worsening of the symptoms. MRI has allowed a differentiation between these two pathologies for selection of different therapies. Gadolinium enhanced MR is at present the single most sensitive and specific imaging modality available to the neuro radiology imager for the evaluation of the post operative lumbosacral spine in the patient presenting with FBSS. Medical imaging specialists and clinicians need to better understand the origins and means of avoiding the FBSS, to more clearly focus the post operative imaging evaluation and to more successfully link the clinical diagnosis and the imaging findings with optimised patient therapy.
| S-EPMC5531858 | biostudies-other
Project description:Background:The optimal treatment of failed back surgery syndrome (FBSS) is controversial. Limited studies have demonstrated the satisfactory outcomes of percutaneous adhesiolysis in FBSS, which can be performed as a 1 day or 3 days procedure. In the current randomized clinical trial, we compared the clinical and functional outcomes of these 2 techniques. Methods:In this study, 60 patients with FBSS were randomly assigned into 2 equal groups: 1 day group and 3 days group. Before and at 4 and 12 weeks after the procedure, pain intensity was measured using visual analogue scale (VAS). The Oswestry disability index (ODI) was also completed. Pain reduction of 50% or more was defined as treatment success. Results:Significant pain relief and ODI improvement were obtained in the 2 groups with adhesiolysis (P < 0.001). However, pain intensity remained the same before and at 4 and 12 weeks after adhesiolysis. ODI score was significantly lower in 1 day group in the 1 month visit (P < 0.001). Treatment was successful in 76.7% and 83.3% of the patients in 1 day and 3 days groups, respectively (P = 0.519). Conclusions:Adhesiolysis is an effective treatment for pain relief and functional improvement in FBSS. The results of 1 day and 3 days procedures are comparable. Based on these findings, the authors recommend using 1 day technique, which can potentially decrease the patients' discomfort, hospital stay, and cost of treatment.
| S-EPMC5903221 | biostudies-literature
Project description:Study designin the rest of the article written as patient- and observer-blinded, multicenter, randomized, intrapatient controlled, noninferiority trial.ObjectiveThe aim of this study was to determine noninferiority of a biphasic calcium-phosphate (AttraX® Putty) as a bone graft substitute for autograft in instrumented posterolateral fusion (PLF).Summary of background dataSpinal fusion with autologous bone graft is a frequently performed surgical treatment. Several drawbacks of autografting have driven the development of numerous alternatives including synthetic ceramics. However, clinical evidence for the standalone use of these materials is limited.MethodsThis study included 100 nontraumatic adults who underwent a primary, single- or multilevel, thoracolumbar, instrumented PLF. After instrumentation and preparation for grafting, the randomized allocation side of AttraX® Putty was disclosed. Autograft was applied to the contralateral side of the fusion trajectory, so each patient served as his/her own control. For the primary efficacy outcome, PLF was assessed at 1-year follow-up on computed tomography scans. Each segment and side was scored as fused, doubtful fusion, or nonunion. After correction for multilevel fusions, resulting in a single score per side, the fusion performance of AttraX Putty was tested with a noninferiority margin of 15% using a 90% confidence interval (CI).ResultsThere were 49 males and 51 females with a mean age of 55.4 ± 12.0 (range 27-79) years. Two-third of the patients underwent a single-level fusion and 62% an additional interbody fusion procedure. The primary analysis was based on 87 patients, including 146 instrumented segments. The fusion rate of AttraX Putty was 55% versus 52% at the autograft side, with an overall fusion rate of 71%. The 90% CI around the difference in fusion performance excluded the noninferiority margin (difference = 2.3%, 90% CI = -9.1% to +13.7%).ConclusionThe results of this noninferiority trial support the use of AttraX Putty as a standalone bone graft substitute for autograft in instrumented thoracolumbar PLF.Level of evidence1.
| S-EPMC7337108 | biostudies-literature
Project description:Despite optimal medical management (OMM), low back pain (LBP) can be disabling, particularly after spinal surgery. Spinal cord stimulation (SCS) is effective in reducing neuropathic leg pain; however, evidence is limited for LBP. This prospective, open-label, parallel-group trial randomized (1:1) failed back surgery syndrome (FBSS) patients with predominant LBP to SCS plus OMM (SCS group) or OMM alone (OMM group) at 28 sites in Europe and the Americas. If trial stimulation was successful, a multicolumn SCS system was implanted. Outcomes were assessed at baseline (before randomization) and at 1, 3, 6, and 12 months after randomization. Patients could change treatment groups at 6 months. The primary outcome was the proportion of patients with ?50% reduction in LBP (responder) at 6 months. Secondary outcomes included change in pain intensity, functional disability, and health-related quality of life (HRQoL). The results are posted at ClinicalTrials.gov under registration number NCT01697358. In the intent-to-treat analysis, there were more responders in the SCS group than in the OMM group (13.6%, 15/110 vs 4.6%, 5/108, difference 9% with 95% confidence interval 0.6%-17.5%, P = 0.036) at 6 months. The SCS group improved in all secondary outcomes compared with the OMM group. The OMM group only improved in HRQoL. In the SCS group, 17.6% (18/102) experienced SCS-related adverse events through 6 months, with 11.8% (12/102) requiring surgical reintervention. Adding multicolumn SCS to OMM improved pain relief, HRQoL, and function in a traditionally difficult-to-treat population of failed back surgery syndrome patients with predominant LBP. Improvements were sustained at 12 and 24 months.
| S-EPMC6553955 | biostudies-literature
Project description: Not available
| S-EPMC7571622 | biostudies-literature
Project description:OBJECTIVES:To compare the effectiveness of peripheral nerve stimulation utilizing a subcutaneous lead implant technique-subcutaneous nerve stimulation (SQS) plus optimized medical management (SQS?+?OMM arm) vs. optimized medical management alone (OMM arm) in patients with back pain due to failed back surgery syndrome. PATIENTS AND METHODS:Patients were recruited from 21 centers, in Europe, Israel, and Australia. Eligible patients were randomized (1:1) to SQS?+?OMM or OMM arms. Those in the SQS arm were implanted with a neurostimulator and up to two subcutaneous percutaneous cylindrical leads in the area of pain. Patients were evaluated pre-randomization and at one, three, six, and nine months post-randomization. The primary endpoint was the proportion of subjects with a ?50% reduction in back pain intensity ("responder") from baseline to nine months. Secondary outcomes included proportion of responders with a ?50% reduction in back pain intensity at six months and ?30% reduction at nine months, and the mean change from baseline in back pain intensity at six and nine months between the two arms. RESULTS:Due to the slow rate of recruitment, the study was terminated early with 116 subjects randomized. A total of 33.9% (19/56, missing: n?=?20 [36%]) of subjects in the SQS?+?OMM arm and 1.7% (1/60, missing: n?=?24 [40%]) in the OMM arm were responders at Month 9 (p?<?0.0001). Secondary objectives showed a significant difference in favor of SQS?+?OMM arm. CONCLUSION:The results indicate that the addition of SQS to OMM is more effective than OMM alone in relieving low back pain at up to nine months.
| S-EPMC6767391 | biostudies-literature
Project description:BACKGROUND:Chronic pain has been associated with alterations in brain structure and function that appear dependent on pain phenotype. Functional connectivity (FC) data on chronic back pain (CBP) is limited and based on heterogeneous pain populations. We hypothesize that failed back surgery syndrome (FBSS) patients being considered for spinal cord stimulation (SCS) therapy have altered resting state (RS) FC cross-network patterns that 1) specifically involve emotion and reward/aversion functions and 2) are related to pain scores. METHODS:RS functional MRI (fMRI) scans were obtained for 10 FBSS patients who are being considered for but who have not yet undergone implantation of a permanent SCS device and 12 healthy age-matched controls. Seven RS networks were analyzed including the striatum (STM). The Wilcoxon signed-rank test evaluated differences in cross-network FC strength (FCS). Differences in periaqueductal grey (PAG) FC were assessed with seed-based analysis. RESULTS:Cross-network FCS was decreased (p<0.05) between the STM and all other networks in these FBSS patients. There was a negative linear relationship (R2 = 0.76, p<0.0022) between STMFCS index and pain scores. The PAG showed decreased FC with network elements and amygdala but increased FC with the sensorimotor cortex and cingulate gyrus. CONCLUSIONS:Decreased FC between STM and other RS networks in FBSS has not been previously reported. This STMFCS index may represent a more objective measure of chronic pain specific to FBSS which may help guide patient selection for SCS and subsequent management.
| S-EPMC7029839 | biostudies-literature
Project description:IntroductionLow-back or leg pain in patients suffering from failed back surgery syndrome (FBSS) is often severe, having a major impact on functionality and quality of life. Despite conservative and surgical treatments, pain can be persistent. An alternative treatment option is epiduroscopy, a minimally invasive procedure based on mechanical adhesiolysis of epidural fibrosis. As epidural fibrosis is speculated to be a major contributor in the pathophysiologic process of FBSS, this review evaluates the effectiveness of epiduroscopy in FBSS patients.Methods and materialsA systematic literature search was performed in PubMed, Embase, and Cochrane databases. Critical appraisal was performed using validated tools. Meta-analysis was performed using generic inverse variance analysis.ResultsFrom the 286 identified articles, nine studies were included. The visual analogue scale (VAS) average was 7.6 at baseline, 4.5 at 6, and 4.3 at 12 months. The Oswestry Disability Index (ODI) average was 61.7% at baseline, 42.8% at 6, and 46.9% at 12 months. An average of 49% of patients experienced significant pain relief at 6 and 37% at 12 months. Meta-analysis showed a pooled VAS mean difference of 3.4 (2.6 to 4.1; 95% confidence interval [CI]) and 2.8 (1.6 to 4.0; 95% CI) and pooled ODI mean difference of 19.4% (12.5 to 26.4%; 95% CI) and 19.8% (13.8 to 25.9%; 95% CI) at 6 and 12 months, respectively.ConclusionCurrent literature demonstrates a clinically relevant reduction in pain and disability scores at 6 to 12 months after mechanical adhesiolysis in FBSS patients. The quality of evidence is moderate, and the level of recommendation is weak. Practitioners should consider the benefits of epiduroscopy after weighing the risks for individual patients with FBSS.
| S-EPMC8049022 | biostudies-literature