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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:BackgroundReherniation rates following lumbar discectomy are low for most patients; however, patients with a large defect in the annulus fibrosis have a significantly higher risk of recurrence. Previous results from a randomized controlled trial (RCT) demonstrated that the implantation of a bone-anchored annular closure device (ACD) during discectomy surgery lowered the risk of symptomatic reherniation and reoperation over one year with fewer serious adverse events (SAEs) compared to discectomy alone.ObjectiveThe objective of this prospective, post-market, historically controlled study was to evaluate the use of an ACD during discectomy, and to confirm the results of the RCT that was used to establish regulatory approval in the United States.MethodsIn this post-market study, all patients (N = 55) received discectomy surgery with a bone-anchored ACD. The comparison population was patients enrolled in the RCT study who had discectomy with an ACD (N = 262) or discectomy alone (N = 272). All other eligibility criteria, surgical technique, device characteristics, and follow-up methodology were comparable between studies. Endpoints included rate of symptomatic reherniation or reoperation, SAEs, and patient-reported measures of disability, pain, and quality of life.ResultsFifty-five patients received ACD implants at 12 sites between May 2020 and February 2021. In the previous RCT, 272 control patients had discectomy surgery alone (RCT-Control), and 262 patients had discectomy surgery with an ACD implant (RCT-ACD). Baseline characteristics across groups were typical of the overall population undergoing lumbar discectomy. The proportion of patients who experienced reherniation and/or reoperation was significantly lower in the ACD group compared to RCT-ACD and RCT-Control groups (p < 0.05). In the ACD study, the one-year rate of symptomatic reherniation was 3.7%, compared to 8.5% in the RCT-ACD group and 17.0% in the RCT-Control group. In the ACD group, the risk of reoperation was 5.5%, compared to 6.5% in the RCT-ACD group and 12.5% in the RCT-Control group. There were no device-related SAEs or device integrity failures in the ACD, and there were clinically meaningful improvements in patient-reported measures of disability, pain, and quality of life.ConclusionIn this post-market study of bone-anchored ACD in patients with large annular defects, rates of symptomatic reherniation, reoperation, and SAEs were all low. Compared to the RCT, the post-market ACD study demonstrated lower rates of reherniation and/or reoperation and measures of back pain one-year post-surgery.

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.

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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