Recurrent Disc Herniation Research Articles

Radiomics based on MRI to predict recurrent L4-5 disc herniation after percutaneous endoscopic lumbar discectomy

BackgroundIn recent years, radiomics has been shown to be an effective tool for the diagnosis and prediction of diseases. Existing evidence suggests that imaging features play a key role in predicting the recurrence of lumbar disk herniation (rLDH). Thus, this study aimed to evaluate the risk of rLDH in patients undergoing percutaneous endoscopic lumbar discectomy (PELD) using radiomics to facilitate the development of more rational surgical and perioperative management strategies.MethodThis was a retrospective case-control study involving 487 patients who underwent PELD at the L4/5 level. The rLDH and negative groups were matched using propensity score matching (PSM). A total of 1409 radiomic features were extracted from preoperative lumbar MRI images using intraclass correlation coefficient (ICC) analysis, t-test, and LASSO analysis. Afterward, 6 predictive models were constructed and evaluated using ROC curve analysis, AUC, specificity, sensitivity, confusion matrix, and 2 repeated 3-fold cross-validations. Lastly, the Shapley Additive Explanation (SHAP) analysis provided visual explanations for the models.ResultsFollowing screening and matching, 128 patients were included in both the recurrence and control groups. Moreover, 18 of the extracted radiomic features were selected for generating six models, which achieved an AUC of 0.551–0.859 for predicting rLDH. Among these models, SVM, RF, and XG Boost exhibited superior performances. Finally, cross-validation revealed that their accuracy was 0.674–0.791, 0.647–0.729, and 0.674–0.718.ConclusionRadiomics based on MRI can be used to predict the risk of rLDH, offering more comprehensive guidance for perioperative treatment by extracting imaging information that cannot be visualized with the naked eye. Meanwhile, the accuracy and generalizability of the model can be improved in the future by incorporating more data and conducting multicenter studies.

A Descriptive Study Risk Factors of Recurrent Lumbar Disk Herniation 1st April 2022 to 2nd April 2023

Purpose: The purpose of this study on recurrent lumbar disc herniation is to determine the causes, clinical findings, and incidence across different age groups above and below 60 years old, as well as gender. The aim is to evaluate the risk factors of recurrent disc herniation in the Afghani population. Methodology: To identify predictors for recurrent lumbar disc herniation (RLDH), a systematic review and meta-analysis were conducted based on existing evidence. The study aimed to provide pooled estimates that may assist various healthcare professionals, including researchers, surgeons, policymakers, caregivers, and patients, in identifying high-risk populations, preventing RLDH, and further investigating the underlying mechanisms. Findings: Risk factors for RLDH are under increasing investigation. Previous studies have examined various potential risk factors such as age, gender, body mass index (BMI), smoking, herniation type, diabetes, and herniation level. However, results from these studies have not always been consistent. For instance, while Kim et al. identified being male as a risk factor for RLDH, other studies did not find significant correlations. Inconsistencies also exist regarding smoking as a risk factor. This study aims to provide more reliable conclusions on these risk factors through a systematic approach. Unique Contribution to Theory, Practice and Policy: Understanding the risk factors associated with recurrent lumbar disc herniation is crucial for improving patient outcomes and reducing the burden on both individuals and society. By identifying and clarifying these risk factors, healthcare professionals can better tailor interventions, treatment plans, and preventive measures for individuals at high risk for RLDH. This study's findings may contribute significantly to the development of strategies aimed at mitigating the recurrence of lumbar disc herniation in the Afghani population.

Risk factor analysis of persistent low back pain after microdiscectomy: A retrospective study

ObjectiveMicrodiscectomy is an effective and safe treatment for patients with symptomatic lumbar disc herniation (LDH) that is refractory to conservative interventions. However, some patients experience persistent low back pain (PLBP) after microdiscectomy that is secondary to progressive disc degeneration and segmental instability. This study aimed to clarify the definition of PLBP and analyze its prevalence and associated risk factors. MethodsThis retrospective study included patients who underwent microdiscectomy for LDH at our hospital between 2015 and 2019. We divided this cohort into patients who did (PLBP group) or did not (non-PLBP group) experience PLBP after microdiscectomy and compared their clinical, radiological, and anatomical parameters. We analyzed the relationship between PLBP post-microdiscectomy and the following variables: age, sex, disk herniation level, recurrent disk herniation, body mass index (BMI), modic changes on MRI, facet subluxation, preoperative lumbar pain, and lumbosacral transitional vertebrae (LSTV). ResultsPLBP after microdiscectomy was diagnosed in 99 (29.8 %) of the 332 patients enrolled in this study. Based on our multivariate logistic regression analysis, L5-S1 disc herniation level, recurrent disc herniation after microdiscectomy, obesity, modic changes on preoperative MRI, and facet subluxation were independent risk factors for PLBP post-microdiscectomy. Women and patients aged <50 years showed a trend of increased risk for developing PLBP after microdiscectomy; however, this trend did not reach statistical significance. ConclusionsPLBP after microdiscectomy is a frequent and understudied condition. We found that an L5-S1 disc herniation level, recurrent disc herniation, obesity, modic MRI changes, and facet subluxation were risk factors for PLBP after microdiscectomy. These results can help surgeons in developing a better understanding of lumbar microdiscectomy outcomes.

Long-term outcomes of caudal epidural steroid injection in failed back surgery syndrome patients with loss of resistance technique

Background: Failed back surgery syndrome (FBSS) is a complicated issue with various treatment approaches. This retrospective study assesses the success and safety of caudal epidural steroid injection (CESI) in FBSS patients utilizing the loss of resistance (LOR) strategy, focusing on long-term outcomes lasting up to two years. Methods: The 75 FBSS patients had CESI with triamcinolone and normal saline under local anesthesia. The visual analog score (VAS), Oswestry disability index (ODI), and patient satisfaction score (PSS) were measured at pre-intervention and 3, 6, 12, 18, and 24 months following the procedure. Result: Majority of patients (57.33%) reported bilateral sciatica, with recurrent disc herniation (54.67%) being the most prevalent MRI finding. Significant improvements (p&lt;0.001) in VAS, ODI, and PSS scores were seen in all subsequent periods. Furthermore, no significant issues reported, demonstrating the safety and effectiveness of CESI with LOR. Conclusions: CESI with the LOR technique is helpful treatment in FBSS at three, six, twelve, eighteen, and twenty-four months. It is easy to perform, less technically demanding, has low complications, and lower costs than surgery. A CESI may offer an alternative approach to managing FBSS for short-term and long-term outcomes.

P58. Clinical and radiographic risk factors for recurrent disc herniation: a systematic review and meta-analysis

P58. Clinical and radiographic risk factors for recurrent disc herniation: a systematic review and meta-analysis

Outcome of intradiscal condoliase injection therapy for patients with recurrent lumbar disc herniation.

Retrospective cohort study. This study aimed to compare data from patients who received intradiscal condoliase (chondroitin sulfate ABC endolyase) injection for primary lumbar disc herniation (LDH) and recurrent LDH. Chemonucleolysis with condoliase for LDH is a treatment with relatively good results and a high safety profile; however, few studies have reported recurrence after LDH surgery. The study participants were 249 patients who underwent intradiscal condoliase injection for LDH at nine participating institutions, including 241 patients with initial LDH (group C) and eight with recurrent LDH (group R). Patient characteristics including age, sex, body mass index, disease duration, intervertebral LDH level, smoking history, and diabetes history were evaluated. Low back pain/leg pain Numerical Rating Scale (NRS) scores and the Oswestry Disability Index (ODI) were used to evaluate clinical symptoms before treatment and at 6 months and 1 year after treatment. Low back pain NRS scores (before treatment and at 6 months and 1 year after treatment, respectively) in group C (4.9 → 2.6 → 1.8) showed significant improvement until 1 year after treatment. Although a tendency for improvement was observed in group R (3.5 → 2.8 → 2.2), no significant difference was noted. Groups C (6.6 → 2.4 → 1.4) and R (7.0 → 3.1 → 3.2) showed significant improvement in the leg pain NRS scores after treatment. Group C (41.4 → 19.5 → 13.7) demonstrated significant improvement in the ODI up to 1 year after treatment; however, no significant difference was found in group R (35.7 → 31.7 → 26.4). Although intradiscal condoliase injection is less effective for LDH recurrence than for initial cases, it is useful for improving leg pain and can be considered a minimally invasive and safe treatment method.

The Impact of Demographic Characteristics, Obesity, Surgical Level, and Intervertebral Disc Properties on Recurrence of Lumbar Disc Herniation

This study focused on identifying factors influencing recurrent lumbar disc herniation (RLDH) by analyzing demographic data, body mass index (BMI), and radiologic disc properties in patients undergoing single-level unilateral lumbar disc herniation surgery. Our retrospective analysis included 2 groups from our clinic: Group 1 (n= 41) with patients experiencing RLDH requiring a second surgery, and Group 2 (n= 73) with patients having a single surgery and no recurrence over at least a 5-year follow-up. We assessed age, sex, diabetes mellitus (DM), hypertension (HT), BMI, Pfirrmann disc degeneration type, herniation types (protrusion, extrusion, and sequestration), and surgical level. The mean ages of Groups 1 and 2 were 48.93 ± 13.47 and 44.4 ± 11.79 years, respectively, with no significant age difference (P= 0.064). Gender distribution was also not significantly different, with 63.41% males in Group 1 and 56.16% in Group 2 (P= 0.450). DM prevalence was similar in both groups (P= 0.727). Notably, HT was significantly lower in Group 2 (P= 0.018). The average BMI was comparable between groups (P= 0.607), and no significant difference in Pfirrmann disc degeneration scores was observed (P= 0.547). Radiologic disc type distributions did not significantly differ (P= 0.448). Most surgeries in both groups were at the L4-5 level, with no significant differences in surgical levels (P= 0.456). We found that factors like gender, age, DM, obesity, surgical level, disc degeneration, and disc types do not significantly impact RLDH. However, the higher occurrence of HT in recurrent cases indicates a potential area for further research.

The comparison study of laminectomy with unilateral and bilateral pedicle screws fixation and laminectomy alone without fusion interbody in young patients with lumbar spinal stenosis: A randomized clinical trial

BackgroundThere are many reports about the risk factors for recurrence after laminectomy surgery. Some surgeons use unilateral and bilateral fusion to provide sufficient stability to the lumbar spine. However, its strength, safety, and effectiveness in young patients are not widely known. Therefore, this study was conducted to compare surgical methods of laminectomy with unilateral and bilateral fixation and laminectomy alone without interbody fusion in young patients with lumbar spinal stenosis. Methods90 patients eligible for lumbar spinal stenosis surgery were selected through convenience sampling and randomly divided into three groups: laminectomy without fixation (A), laminectomy with unilateral fixation (B), and bilateral fixation (C). Pain, functional disability, quality of life, recurrent disc, adjacent segment disease (ASD), and fusion rate were evaluated and compared among the three groups six months post-surgery. The data were analyzed using SPSS version 16. ResultsSix months after surgery, the mean score of functional disability in the bilateral group was significantly higher than the other groups (12.92 (3.30) vs 5.52 (1.91) and 4.30 (1.84), P < 0.05). Also, the highest mean score of pain after surgery was observed in the bilateral group (4.33 (0.70) vs 1.81(0.68) and 1.63(0.56), P < 0.05). The mean score of quality of life in the unilateral group was significantly higher than the other groups (87.81 (5.67) vs 68.58 (3.08) and 56.07 (4.04), P < 0.05). No significant difference was observed between the groups (P > 0.05) regarding fusion, recurrent disc herniation, and adjacent segment disease. ConclusionsUnilateral fixation provides the same benefits as bilateral fixation but has the additional benefits of being less invasive and minimizing the disadvantages of other investigated techniques during and after surgery.

90-Day Emergency Department Utilization and Readmission Rate After Full-Endoscopic Spine Surgery: A Multicenter, Retrospective Analysis of 821 Patients.

Emergency department (ED) utilization and readmission rates after spine surgery are common quality of care measures. Limited data exist on the evaluation of quality indicators after full-endoscopic spine surgery (FESS). The objective of this study was to detect rates, causes, and risk factors for unplanned postoperative clinic utilization after FESS. This retrospective multicenter analysis assessed ED utilization and clinic readmission rates after FESS performed between 01/2014 and 04/2023 for degenerative spinal pathologies. Outcome measures were ED utilizations, hospital readmissions, and revision surgeries within 90 days postsurgery. Our cohort includes 821 patients averaging 59 years of age, who underwent FESS. Most procedures targeted the lumbar or sacral spine (85.75%) while a small fraction involved the cervical spine (10.11%). The most common procedures were lumbar unilateral laminotomies for bilateral decompression (40.56%) and lumbar transforaminal discectomies (25.58%). Within 90 days postsurgery, 8.0% of patients revisited the ED for surgical complications. A total of 2.2% of patients were readmitted to a hospital of which 1.9% required revision surgery. Primary reasons for ED visits and clinic readmissions were postoperative pain exacerbation, transient neurogenic bladder dysfunction, and recurrent disk herniations. Our multivariate regression analysis revealed that female patients had a significantly higher likelihood of using the ED (P = .046; odds ratio: 1.77, 95% CI 1.01-3.1 5.69% vs 10.33%). Factors such as age, American Society of Anesthesiologists class, body mass index, comorbidities, and spanned spinal levels did not significantly predict postoperative ED utilization. This analysis demonstrates the safety of FESS, as evidenced by acceptable rates of ED utilization, clinic readmission, and revision surgery. Future studies are needed to further elucidate the safety profile of FESS in comparison with traditional spinal procedures.

134 How to Spot the Recurring Lumbar Disc? Risk Factors for Recurrent Lumbar Disc Herniation in Adult Patients with Lumbar Disc Prolapse: A Systematic Review and Meta-Analysis

Abstract Aim Despite a fast-growing evidence-base examining the relationship of certain clinical and radiological factors such as smoking, BMI and herniation-type with recurrent lumbar disc herniation (rLDH), there remains much debate around which factors are clinically important. We conducted a systematic review and meta-analysis to identify risk factors for rLDH in adults after primary disc surgery. Method A systematic literature search was performed using Ovid-Medline, EMBASE, Cochrane library and Web of Science databases from inception to 23rd June-2022. Observational studies of adult patients with radiologically confirmed rLDH ≥3 months after the initial surgery were included, and their quality assessed using the Quality-In-Prognostic-Studies (QUIPS) appraisal tool. Meta-analyses of univariate and multivariate data and a sensitivity-analysis for rLDH post-microdiscectomy were carried out. Results Twelve studies (n=4497, mean-age: 47.3; 34.5% female) were included, of which 11 studies were meta-analysed (n=4235). The mean follow-up was 38.4 months. Mean recurrence-rate was 13.1% and mean time-to-recurrence was 24.1 months (range: 6-90 months). Clinically, older age (OR:1.04, 95% CI:1.00-1.08, n=1014), diabetes mellitus (OR:3.82, 95% CI:1.58-9.26, n=2330) and smoking (OR:1.80, 95% CI:1.03-3.14, n=3425) increased likelihood of recurrence. Radiologically, Modic-change type-2 (OR:7.93, 95% CI:5.70-11.05, n=1706) and disc-extrusion (OR:12.23, 95% CI:8.60-17.38, n=1706) increased likelihood of recurrence. The evidence did not support an association between rLDH and sex; BMI; occupational-labour; alcohol-consumption; Pfirmann-grade, or herniation-level. Conclusions Older patients, smokers, patients with diabetes, those with type-2 Modic-changes or disc-extrusion are more likely to experience rLDH. Higher quality studies with robust adjustment of confounders are required to determine the clinical bearing of all other potential risk factors on rLDH.

Exosome-mediated Repair of Intervertebral Disc Degeneration: The Potential Role of miRNAs.

Intervertebral disc degeneration (IVDD) is a serious condition that manifests as low back pain, intervertebral disc protrusion, and spinal canal stenosis. At present, the main treatment methods for IVDD are surgical interventions such as discectomy, total disc replacement, and spinal fusion. However, these interventions have shown limitations, such as recurrent lumbar disc herniation after discectomy, lesions in adjacent segments, and failure of fixation. To overcome these shortcomings, researchers have been exploring stem cell transplantation therapy, such as mesenchymal stem cell (MSC) transplantation, but the treatment results are still controversial. Therefore, researchers are in search of new methods that are more efficient and have better outcomes. The exosomes from stem cells contain a variety of bioactive molecules that mediate cell interactions, and these components have been investigated for their potential therapeutic role in the repair of various tissue injuries. Recent studies have shown that MSC-derived miRNAs in exosomes and vesicles have therapeutic effects on nucleus pulposus cells, annulus fibrosus, and cartilage endplate. miRNAs play a role in many cell activities, such as cell proliferation, apoptosis, and cytokine release, by acting on mRNA translation, and they may have immense therapeutic potential, especially when combined with stem cell therapy. This article reviews the current status of research on intervertebral disc repair, especially with regard to the latest research findings on the molecular biological mechanisms of miRNAs in MSC-derived exosomes in intervertebral disc repair.

Is spinal fusion the preferred treatment for recurrent lumbar disc herniation of the lumbar spine?

Is spinal fusion the preferred treatment for recurrent lumbar disc herniation of the lumbar spine?

Pseudomeningocele Mimicking Sciatica

We report on an elderly woman with sciatica due to disc herniation, experiencing complete pain resolution following surgery. Four weeks later, she developed refractory, excruciating pain with foot palsy, prompting a lumbar magnetic resonance imaging that revealed no recurrent disc herniation. Upon exploration, intermittent nerve entrapment through the dural tear and pseudomeningocele was identified. Following dural repair and nerve repositioning, the postoperative course and long-term outcome were uneventful.In contrast to recurrent disc herniation, sciatica resulting from nerve entrapment by a pseudomeningocele is exceedingly rare. Its differential diagnosis is crucial in cases with seemingly unspectacular magnetic resonance imaging findings, as paralysis can occur in symptomatic patients. The radiological presence of a postoperative pseudomeningocele could be overlooked, and the cause of sciatica might become apparent solely during surgical exploration.

Risk factors for reoperation after discectomy of lumbar herniated intervertebral disc disease.

Discectomy is the most common surgery for lumbar herniated intervertebral disc (HIVD) disease. However, 5%-24% of patients undergo a second surgery due to recurrent disc herniation. This study was aimed to identify the risk factors for reoperation after discectomy of lumbar HIVD and recommend treatment for patients with a high risk of reoperation. We recruited patients diagnosed as having single-level lumbar HIVD who underwent open discectomy from January 1, 2000, to December 31, 2012 in our hospital. We used a survival curve to inspect the survival time and reoperation rate after surgery. We discussed the correlation of reoperation rate with discectomy level, body mass index, heavy lifting after surgery, sex, and age. Furthermore, we investigated the correlation between the experience of a surgeon and the reoperation rate. A total of 619 patients were enrolled in our study. Most patients were 40-60 years old (48.8%), and most of them had herniation at L4/5 level (48.9%). The 8-year survival rate was 92%. Weight lifting after surgery may increase the reoperation rate by 115 and 18 times for those >60 years and <40 years, respectively. In addition, less experience of the surgeon and female sex had a high reoperation rate. Postoperative working modification may be very important for preventing patients from recurrent HIVD. For elderly people with HIVD, a more conservative therapy could be selected. If patients with lumbar spine hypermobility or severe degeneration require wide laminectomy, primary fusion should be considered.

Comparison of histopathologic findings of initial and recurrent lumbar disc herniation

Objective: Recurrent lumbar disc hernia (RLDH) is a common and challenging complication after an initial discectomy. This study aimed to investigate the relationship between the histopathologic outcomes of the initial and recurrent disc tissues. Methods: This study investigated 70 patients who underwent a microdiscectomy and subsequently developed same-level same-side lumbar disc herniation (LDH) recurrence. The clinic, western blot, and immunohistochemical evaluations of patients with initial LDH and RLDH were conducted and statistically analyzed. Results: The effect of inflammation and apoptosis in the degenerative changes of intervertebral disc hernia and increased histopathologic findings in RLDH was demonstrated. The degeneration of the hernia disc tissue is a major pathological process, which is characterized by cellular apoptosis, inflammation, and reduced synthesis of extracellular matrix. Currently, there is no clinical therapy targeting the reversal of disc degeneration. Conclusions: This, therefore, stay away from factors that increase inflammation in the intervention of intervertebral disc hernia, applying to reduce inflammation the medicines, could allow reducing disc collagen degeneration, and more successful outcomes. These findings might shed some new lights on the mechanism of disc degeneration and provide new strategies for the treatments of initial and recurrent LDH.

Repeat Discectomy or Instrumented Surgery for Recurrent Lumbar Disk Herniation: An Overview of French Spine Surgeons' Practice.

Retrospective multicenter cohort study. Recurrent lumbar disc herniation (ReLDH) is a common condition requiring surgical intervention in a large proportion of cases. Evidence regarding the appropriate choice between repeat microdiscectomy (RD) and instrumented surgery (IS) is lacking. To understand the indications for either of the procedures and compare the results, we aimed to provide an overview of spine surgeon practice in France. This retrospective, multicenter analysis included adults who underwent surgery for ReLDHs between December 2020 and May 2021. Surgeons were asked which of the following factors determined their therapeutic choice: radio-clinical considerations, non-discal anatomical factors, patient preference, or surgeon background. Data on preoperative clinical status and radiologic findings were collected. Patient-reported outcome measures (PROMs) were assessed and compared using propensity scores preoperatively and at 3 and 12 months postoperatively. The study included 150 patients (72 IS and 78 RD). Radioclinical elements, anatomical data, patient preferences, and surgeon background influenced the choice of RD in 57.7%, 1.3%, 25.6%, and 15.4% of the cases, respectively, and IS in 34.7%, 6.9%, 13.9%, and 44.5% of the cases, respectively. At 12 months, patient satisfaction, return to work, and changes in PROMs were not significantly different between the groups. The decision-making process included both objective and subjective factors, resulting in patient satisfaction in 80.3% to 81.5% of cases, with significant clinical improvement in radicular symptoms in 75.8% to 91.8% of cases, and quality of life in 75.8% to 84.9% of cases, depending on the procedure performed.

Incidental durotomy resulting in a postoperative lumbosacral nerve root with eventration into the adjacent facet joint: illustrative cases.

Radicular pain after lumbar decompression surgery can result from epidural hematoma/seroma, recurrent disc herniation, incomplete decompression, or other rare complications. A less recognized complication is postoperative nerve root herniation, resulting from an initially unrecognized intraoperative or, more commonly, a spontaneous postoperative durotomy. Rarely, this nerve root herniation can become entrapped within local structures, including the facet joint. The aim of this study was to illustrate our experience with three cases of lumbosacral nerve root eventration into an adjacent facet joint and to describe our diagnostic and surgical approach to this rare complication. Three patients who had undergone lumbar decompression surgery with or without fusion experienced postoperative radiculopathy. Exploratory revision surgery revealed all three had a durotomy with nerve root eventration into the facet joint. Significant symptom improvement was achieved in all patients following liberation of the neural elements from the facet joints. Entrapment of herniated nerve roots into the facet joint may be a previously underappreciated complication and remains quite challenging to diagnose even with the highest-quality advanced imaging. Thus, clinicians must have a high index of suspicion to diagnose this issue and a low threshold for surgical exploration.

Lumbar lordosis and sacral slope do not differ in two types of postoperative lumbar disc re-herniation: a cross-sectional observational study

BackgroundTo identify the differences of lumbar lordosis (LL) and sacral slope (SS) angles between two types of postoperative lumbar disc re-herniation, including the recurrence of same level and adjacent segment herniation (ASH).MethodsWe searched the medical records of lumbar disc herniation (LDH) patients with re-herniation with complete imaging data (n = 58) from January 1, 2013 to December 30, 2020 in our hospital. After matching for age and sex, 58 patients with LDH without re-herniation from the same period operated by the same treatment group in our hospital were served as a control group. Re-herniation patients were divided into two groups, same-level recurrent lumbar disc herniation group (rLDHG) and adjacent segment herniation group with or without recurrence (ASHG). The preoperative, postoperative and one month after operation LL and SS were measured on standing radiographs and compared with the control group by using t-test, ANOVA, and rank-sum test. Next, we calculated the odds ratios (ORs) by unconditional logistic regression, progressively adjusted for other confounding factors.ResultsCompared with the control group, the postoperative LL and SS were significantly lower in LDH patients with re-herniation. However, there were no differences in LL and SS between ASHG and rLDHG at any stage. After progressive adjustment for confounding factors, no matter what stage is, LL and SS remained unassociated with the two types of re-herniation.ConclusionsLow postoperative LL and SS angles are associated with degeneration of the remaining disc. Low LL and SS may be independent risk factors for re-herniation but cannot determine type of recurrence (same or adjacent disc level).

Utilization of Bone-Anchored Annular Defect Closure to Prevent Reherniation Following Lumbar Discectomy: Overcoming Barriers to Clinical Adoption and Market Access.

While achieving premarket approval from the US Food and Drug Administration represents a significant milestone in the development and commercialization of a Class III medical device, the aftermath endeavor of gaining market access can be daunting. This article provides a case study of the Barricaid annular closure device (Barricaid), a reherniation reduction device, which has been demonstrated to decrease the risk of suffering a recurrent lumbar intervertebral disc herniation. Following Food and Drug Administration approval, clinical adoption has been slow due to barriers to market access, including the perception of low-quality clinical evidence, questionable significance of the medical necessity of the procedure, and imaging evidence of increased likelihood of vertebral endplate changes. The aim of this article is to provide appropriate examination, rationale, and rebuttal of these concerns. Weighing the compendium of evidence, we offer a definition of a separate and unique current procedural terminology code to delineate this procedure. Adoption of this code will help to streamline the processing of claims and support the conduct of research, the evaluation of health care utilization, and the development of appropriate medical guidelines.

Pedicle Screw and Rod Fixation with TLIF in a Series of 14 Patients with Recurrent Lumbar Disc Herniation

Pedicle Screw and Rod Fixation with TLIF in a Series of 14 Patients with Recurrent Lumbar Disc Herniation