Dataset Information

Effect of a strutted intradiscal spacer (DIVA®) on disc reherniation following lumbar discectomy: A 2-year retrospective matched cohort study.

ABSTRACT:

Introduction

Discectomy for lumbar disc herniation has a high rate of reoperation and recurrent herniation.

Methods

Retrospectively matched cohort of patients undergoing lumbar discectomy alone or with a strutted intradiscal spacer.

Results

133 discectomy and 112 patients with discectomy plus spacer were included. Pain and disability scores were significantly lower for both groups at 2 years. Patients receiving a strutted intradiscal spacer following discectomy had a reduced rate of all-cause reoperations and operations for recurrent herniations compared to discectomy alone.

Conclusion

Use of a strutted intradiscal spacer following discectomy improves surgical outcomes following surgery for lumbar herniation versus discectomy alone.

SUBMITTER: Srour R

PROVIDER: S-EPMC8131955 | biostudies-literature | 2021 May-Jun

REPOSITORIES: biostudies-literature

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Publications

Effect of a strutted intradiscal spacer (DIVA®) on disc reherniation following lumbar discectomy: A 2-year retrospective matched cohort study.

Srour Robin R El Arbi Amira A Rahmouni Ahmed A Aljohani Hani H Orenstein Daniel D Hoarau Xavier X Benali Mustapha Ali MA Mortada Jihad J Sellal François F

Journal of orthopaedics 20210507

<h4>Introduction</h4>Discectomy for lumbar disc herniation has a high rate of reoperation and recurrent herniation.<h4>Methods</h4>Retrospectively matched cohort of patients undergoing lumbar discectomy alone or with a strutted intradiscal spacer.<h4>Results</h4>133 discectomy and 112 patients with discectomy plus spacer were included. Pain and disability scores were significantly lower for both groups at 2 years. Patients receiving a strutted intradiscal spacer following discectomy had a reduce ...[more]

PMID: 34025061

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Project description:BackgroundPatients 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 methodsThis 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 disseminationThis 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 registrationClinicalTrials.gov (https://clinicaltrials.gov): NCT03986580.Level of evidence3.

Project description:BackgroundA larger defect in the annulus fibrosus following lumbar discectomy is a well-known risk factor for reherniation. Procedures intended to prevent reherniation by sealing or occluding the annular defect warrant study in high-risk patients. This study sought to determine 3-year results of lumbar discectomy with a bone-anchored annular closure device (ACD) or lumbar discectomy only (controls) in patients at high risk for reherniation.MethodsThis multicenter randomized trial enrolled patients with sciatica due to lumbar intervertebral disc herniation who failed conservative treatment. Patients with large annular defects after lumbar limited microdiscectomy were intraoperatively randomly assigned to receive ACD or control. Clinical and imaging follow-up was performed at routine intervals over 3 years. Main outcomes included rate of reherniations, reoperations, and endplate changes; leg and back pain scores on a visual analogue scale; Oswestry Disability Index (ODI); Physical Component Summary (PCS) and Mental Component Summary (MCS) scores from the SF-36; and adverse events adjudicated by a data safety monitoring board.ResultsAmong 554 randomized patients, the modified intent-to-treat population consisted of 272 patients in which ACD implantation was attempted and 278 receiving control; device implantation was not attempted in 4 patients assigned to ACD. Outcomes at 3 years favored ACD for symptomatic reherniation (14.8% vs. 29.5%; P < 0.001), reoperation (11.0% vs. 19.3%; P = 0.007), leg pain (21 vs. 30; P < 0.01), back pain (23 vs. 30; P = 0.01), ODI (18 vs. 23; P = 0.02), PCS (47 vs. 44; P < 0.01), and MCS (52 vs. 49; P < 0.01). The frequency of all-cause serious adverse events was comparable between groups (42.3% vs. 44.5%; P = 0.61).ConclusionsThe addition of a bone-anchored ACD in patients with large annular defects following lumbar discectomy reduces the risk of reherniation and reoperation, and has a similar safety profile over 3-year follow-up compared with lumbar limited discectomy only.Trial registrationClinicalTrials.gov NCT01283438.

Project description:ObjectiveThis study aimed to compare the mid-term outcomes and patient satisfaction between percutaneous endoscopic lumbar discectomy (PELD) and microendoscopic discectomy (MED) for the treatment of foraminal and extraforaminal lumbar disc herniations.MethodsA retrospective matched cohort study was conducted, including patients diagnosed with foraminal or extraforaminal lumbar disc herniations who underwent PELD or MED between January 2014 and December 2021. Patient demographics, clinical characteristics, and perioperative data were analyzed. Primary outcomes included Visual Analog Scale (VAS) scores for pain, Japanese Orthopaedic Association (JOA) scores and improvement rates for functional status, and overall satisfaction at a minimum 2-year follow-up.ResultsA total of 133 patients were included in the final analysis. The PELD group demonstrated a significantly greater reduction in VAS scores for low back pain (6.74 ± 1.21 to 1.95 ± 0.42) compared to the MED group (6.93 ± 1.17 to 2.35 ± 0.89) at the 2-year follow-up (p < 0.001). Both groups exhibited significant improvements in JOA scores, with no notable differences observed at the final follow-up. Patient satisfaction rates were higher in the PELD group, with 86% reporting high satisfaction compared to 72% in the MED group; however, this difference was not statistically significant. Logistic regression analysis identified VAS scores for low back pain, operation cost, and symptom recurrence as independent factors influencing patient dissatisfaction at 2 years post-surgery.ConclusionBoth PELD and MED demonstrated efficacy in treating foraminal and extraforaminal lumbar disc herniations over a 2-year follow-up period. PELD, however, exhibited superior relief of low back pain. Factors, such as low back pain intensity, surgical costs, and symptom recurrence significantly impacted patient dissatisfaction, despite comparable overall satisfaction rates between the two surgical techniques.

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.

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: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

Effect of a strutted intradiscal spacer (DIVA®) on disc reherniation following lumbar discectomy: A 2-year retrospective matched cohort study.

Introduction

Methods

Results

Conclusion

Publications

Effect of a strutted intradiscal spacer (DIVA®) on disc reherniation following lumbar discectomy: A 2-year retrospective matched cohort study.

Similar Datasets

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