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Multicenter study of lumbar discectomy with Barricaid annular closure device for prevention of lumbar disc reherniation in US patients: A historically controlled post-market study protocol.

ABSTRACT: BACKGROUND:Patients with large defects in the annulus fibrosus following lumbar discectomy have high rates of symptomatic reherniation. The Barricaid annular closure device provides durable occlusion of the annular defect and has been shown to significantly lower the risk of symptomatic reherniation in a large European randomized trial. However, the performance of the Barricaid device in a United States (US) population has not been previously reported. DESIGN AND METHODS:This is a historically controlled post-market multicenter study to determine the safety and efficacy of the Barricaid device when used in addition to primary lumbar discectomy in a US population. A total of 75 patients with large annular defects will receive the Barricaid device following lumbar discectomy at up to 25 sites in the US and will return for clinical and imaging follow-up at 4 weeks, 3 months, and 1 year. Trial oversight will be provided by a data safety monitoring board and imaging studies will be read by an independent imaging core laboratory. Patients treated with the Barricaid device in a previous European randomized trial with comparable eligibility criteria, surgical procedures, and outcome measures will serve as historical controls. Main outcomes will include back pain severity, leg pain severity, Oswestry Disability Index, health utility on the EuroQol-5 Dimension questionnaire, complications, symptomatic reherniation, and reoperation. Propensity score adjustment using inverse probability of treatment weighting will be used to adjust for differences in baseline patient characteristics between the US trial participants and European historical controls. ETHICS AND DISSEMINATION:This study was approved by a central institutional review board. The study results of this trial will be widely disseminated at conference proceedings and published in peer-reviewed journals. The outcomes of this study will have important clinical and economic implications for all stakeholders involved in treating patients with lumbar discectomy in the US. STUDY REGISTRATION:ClinicalTrials.gov (https://clinicaltrials.gov): NCT03986580. LEVEL OF EVIDENCE:3.

SUBMITTER: Strenge KB

PROVIDER: S-EPMC6736093 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Multicenter study of lumbar discectomy with Barricaid annular closure device for prevention of lumbar disc reherniation in US patients: A historically controlled post-market study protocol.

Strenge K Brandon KB DiPaola Christian P CP Miller Larry E LE Hill Clint P CP Whitmore Robert G RG

Medicine 20190801 35

<h4>Background</h4>Patients with large defects in the annulus fibrosus following lumbar discectomy have high rates of symptomatic reherniation. The Barricaid annular closure device provides durable occlusion of the annular defect and has been shown to significantly lower the risk of symptomatic reherniation in a large European randomized trial. However, the performance of the Barricaid device in a United States (US) population has not been previously reported.<h4>Design and methods</h4>This is a ...[more]

PMID: 31464935

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Project description:Study design/setting Retrospective analysis of single-center registry outcomes data. Objective Assess the utility of an annular closure device (ACD) as an adjunct to limited discectomy for lumbar disc herniation (LDH). Background Recurrent lumbar disc herniation (rLDH) following limited discectomy persists at clinically significant rates, especially in large annular defect (at least 6 mm width) patients. While the etiology of reherniation is often multifactorial, inadequate annular occlusion remains one of the foremost considerations. Accordingly, annular closure has emerged as a promising technique and is the focus of this analysis. Methods This was a retrospective analysis of 171 patients who underwent limited lumbar discectomy with an ACD for LDH. Standardized patient assessment was performed preoperatively, three months postoperatively, and 12 months postoperatively, in addition to self-presented visits. No minimum last follow-up was required for inclusion. Oswestry Disability Index (ODI) and Visual Analog Scale (VAS Leg/Back) pain scores were collected at all visits. Plain radiographs were obtained at all visits, with magnetic resonance imaging (MRI) scans performed annually and/or when patients presented as symptomatic. ACD-related complications due to partial or complete mesh detachment from the titanium anchor were reported. All secondary surgical interventions were also reported. The Wilcoxon Rank-sum test was used to compare outcomes and events between sub-groups (p < 0.05). Results Mean last follow-up for all patients was 15 months. Large annular defects were present in 154 patients (90%). Symptomatic reherniations were observed in six patients (3.5%; five were present in the large annular defect subpopulation). All patients demonstrated clinically meaningful improvement in clinical outcome scores at both follow-up intervals. ACD mesh detachment was observed in 15 patients (8.8%; two underwent a subsequent surgical intervention). No symptomatic reherniations were observed in secondary herniation patients compared to six (4.1%) in the primary herniation group (p = 0.60). Conclusions Annular closure with the ACD results in clinically meaningful improvements in both primary and secondary LDH patients, with decreased rates of reherniation in high-risk patients compared to previous discectomy reports.

Project description:Background:Percutaneous endoscopic transforaminal discectomy (PETD) is regarded as a viable alternative option for upper lumbar disc herniation (LDH). However, few studies have evaluated PETD for upper LDH, and no study has compared the advantages of endoscopic procedures versus conventional surgery. The present study was aimed at comparing the surgical outcome and safety of PETD versus conventional open lumbar discectomy in the treatment of upper LDH. Methods:Data from 42 patients treated for upper LDH from July 2015 to July 2018 were retrospectively analyzed, including 21 patients treated with PETD (PETD group) and 21 patients treated with conventional posterior lumbar discectomy (open group). The two groups were compared regarding demographic information, physical examination, radiological evaluations, and perioperative indicators. The clinical outcomes were assessed in accordance with the Oswestry Disability Index (ODI), visual analog scale (VAS), and modified MacNab criteria. Results:The postoperative ODI and VAS scores were significantly improved in both groups compared with the preoperative baseline values (P < 0.001), and the satisfactory rate was 90.5% in both groups in accordance with the modified MacNab criteria. There were no significant differences between the two groups in the clinical outcomes and complication rate (P < 0.001), and the satisfactory rate was 90.5% in both groups in accordance with the modified MacNab criteria. There were no significant differences between the two groups in the clinical outcomes and complication rate (P < 0.001), and the satisfactory rate was 90.5% in both groups in accordance with the modified MacNab criteria. There were no significant differences between the two groups in the clinical outcomes and complication rate (. Conclusions:PETD has a similar outcome to the conventional surgical method for the treatment of upper LDH but provides the typical advantages of minimally invasive procedures such as reduced iatrogenic injury, minimal activity restrictions, and accelerated ambulation recovery postoperatively.

Project description:PurposeDespite being an extremely successful procedure, recurrent disc herniation is one of the most common post-discectomy complications in the lumbar spine and contributes significant health care and socioeconomic costs. Patients with large annular defects are at a high risk for reherniation, but an annular closure device (ACD) has been designed to reduce reherniation risk in this population and may, in turn, help control direct health care costs after discectomy.Patients and methodsThis analysis examined the 90-day post-discectomy cost estimates among ACD-treated (n=272) and control (discectomy alone; n=278) patients in a randomized controlled trial (RCT). Direct medical costs were estimated based on 2017 Humana and Medicare claims. Index discectomies were assumed to occur in an outpatient (OP) setting, whereas repeat discectomies were assumed to be 60% in OP and 40% in inpatient (IP). A sensitivity analysis was performed on this assumption. The device cost was not included in the analysis in order to focus on costs in the 90-day post-operative period.ResultsWithin 90 days of follow-up, post-operative complications occurred in 3.3% of the ACD patients and 8.6% of the control patients (P=0.01). The average 90-day cost to treat an ACD patient was $10,257 compared to $11,299 per control patient for a 80:20 distribution of Commercial:Medicare coverage ($1,042 difference). This difference varied from $687 with 100% Medicare to $1,132 with 100% Commercial coverage. Varying the IP vs OP distribution resulted in a cost difference range of $968 to $1,156 with the ACD.ConclusionAugmenting discectomy with an ACD in high-risk patients with a large annular defect reduced reherniation and reoperation rates, which translated to a reduction of direct health care costs between $687 and $1,156 per patient during the 90-day post-operative period. Large annular defect patients are an easily identifiable high-risk population. Operative strategies that reduce complication risks in these patients, such as the ACD, could be advantageous from both patient care and economic perspectives.

Project description:Study designSecondary analysis of data from a concurrent randomized trial and cohort study.ObjectiveThe aim of this study was to determine risks and predictors of recurrent pain following standard open discectomy for subacute/chronic symptomatic lumbar disc herniation (SLDH).Summary of background dataMost previous studies of recurrence after discectomy do not explicitly define pain resolution and recurrence, and do not account for variable durations of time at risk for recurrence.MethodsWe used survival analysis methods to examine predictors of leg pain recurrence. For individuals with initial resolution of leg pain, we defined recurrent leg pain as having leg pain, receiving lumbar epidural steroid injections, or undergoing lumbar surgery subsequent to initial leg pain resolution. We calculated cumulative risks of leg pain recurrence using Kaplan-Meier survival curves, and examined predictors of recurrence using Cox proportional hazards models. We used similar methods to examine LBP recurrence.ResultsOne- and three-year cumulative risks of leg pain recurrence were 20% and 45%, respectively. One- and three- year leg pain recurrence risks were substantially lower in participants with complete initial resolution of leg pain (17% and 41%, respectively) than in those without (27% and 54%, respectively). In multivariate analyses, complete leg pain resolution (adjusted hazard ratio [aHR] 0.69; 95% confidence interval [CI] 0.52-0.90), smoking (aHR 1.68 [95% CI 1.22-2.33]), and depression (aHR 1.74 [95% CI 1.18-2.56]) predicted leg pain recurrence. The 1- and 3-year risk of LBP recurrence was 29% and 65%, respectively. LBP recurrence risk at 3 years was substantially lower in participants with complete initial resolution of LBP than in those without, but not at 1 year.ConclusionRecurrence of leg pain and LBP is common after discectomy for SLDH. Cumulative risks of both leg pain and LBP recurrence were generally lower in participants achieving complete initial resolution of pain post-discectomy.Level of evidence2.

Project description:Background:The purposes of the present study were to (1) confirm the risk of recurrent lumbar disc herniation in patients with a large anular defect who had undergone limited discectomy and (2) assess potential risk factors within this population. Methods:The patient population was extracted from the control cohort of a prospective, randomized, multicenter controlled trial investigating the efficacy of an anular closure device following standard limited discectomy. All control patients underwent limited discectomy for the treatment of a single-level symptomatic posterior or posterolateral lumbar disc herniation. Only patients presenting with a large anular defect (6 to 10 mm wide by 4 to 6 mm long) were included in the study (n = 278). Baseline demographic, clinical, and surgical characteristics were recorded. Follow-up evaluations were performed at 6 weeks and at 3, 6, 12, and 24 months. Imaging modalities included magnetic resonance imaging, low-dose computed tomography, and radiographs. Symptomatic recurrent lumbar disc herniation was defined as any symptomatic postoperative herniation on either side of the index level. A multivariate logistic regression analysis of demographic and surgical variables associated with the incidence of recurrent lumbar disc herniation was performed. Results:The mean anular defect area (and standard deviation) was 39.3 ± 9.1 mm2, and the mean excised nuclear tissue volume was 1.3 ± 0.8 mL. At 2 years, the incidence of symptomatic recurrent lumbar disc herniation was 25.3% (64 of 253), with the herniation occurring at a mean of 264 days after the index procedure. Of the 64 patients with recurrent lumbar disc herniation, 36 underwent a subsequent surgical procedure. Logistic regression analysis identified an increased risk for recurrent lumbar disc herniation in females (odds ratio, 2.2) and in patients with greater anular defect widths (odds ratio, 1.3). Furthermore, multivariate logistic regression analyses revealed a significant interaction between age and sex (p = 0.005). Conclusions:The outcomes of the present study provide the most substantial evidence to date in confirming previous reports of a high risk of reherniation among patients with large anular defects. Among those with large anular defects (width, ?6 mm), females ?50 years of age had the highest risk (up to ?10 times higher) of recurrent lumbar disc herniation. It is recommended that an anular repair or closure should be performed after limited discectomies in patients with large anular defects. Level of Evidence:Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Dataset Information

Multicenter study of lumbar discectomy with Barricaid annular closure device for prevention of lumbar disc reherniation in US patients: A historically controlled post-market study protocol.

Publications

Multicenter study of lumbar discectomy with Barricaid annular closure device for prevention of lumbar disc reherniation in US patients: A historically controlled post-market study protocol.

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