Reherniation Rate Research Articles

Innovative hydrogel-patch combination for large annulus fibrosus defects: a prospective approach to address herniation recurrence

BACKGROUND CONTEXTLarge annulus fibrosus (AF) defects often lead to a high rate of reherniation, particularly in the medial AF region, which has limited self-healing capabilities. The increasing prevalence of herniated discs underscores the need for effective repair strategies. PURPOSEThe objectives of this study were to design an AF repair technique to reduce solve the current problems of insufficient mechanical properties and poor sealing capacity. STUDY DESIGNIn vitro biomechanical experiments and finite element analysis. METHODSThe materials used in this study were patches and hydrogels with good biocompatibility and sufficient mechanical properties to withstand loading in the lumbar spine. Five repair techniques were assessed in this study: hydrogel filler (HF), AF patch medial barrier (MB), AF patch medial barrier and hydrogel filler (MB&HF), AF patch medial-lateral barrier (MLB), and AF patch medial-lateral barrier and hydrogel filler (MLB&HF). The repair techniques were subjected to in vitro testing (400 N axial compression and 0–500 N fatigue loading at 5Hz) and finite element analysis (400 N axial compression) to evaluate the effectiveness at repairing large AF defects. The evaluation included repair tightness, spinal stability, and fatigue resistance. RESULTSFrom the in vitro testing, the failure load of the repair techniques was in the following order HF <MB <MB&HF <MLB <MLB&HF. Both HF and MB groups failed to effectively increase intervertebral disc (IVD) stiffness, resulting in a reduction in spatial stability. The MLB, MB&HF, and MLB&HF groups partially restored IVD stiffness, with MLB&HF showing the most effective recovery (−24.13% ± 3.59%). From the finite element models, incorporating a hydrogel filler was best able to maintain the IVD height. Patch repair alone could not adequately reduce the high AF stress due to AF injury, but with hydrogel support, stress was substantially low and more uniformly distributed. All repair techniques demonstrated reduced stress around the damaged area on the AF, in comparison to the unrepaired model. The NP pressure in the HF group was closest to the intact group, and the patch repair reduced the NP pressure. The maximum patch deformation and suture stress were ranked as MB >MLB >MB&HF >MLB&HF. CONCLUSIONSThe combined use of patches and hydrogels exhibited promising mechanical properties postdiscectomy, providing a promising solution for addressing large AF defects and improving disc stability. CLINICAL SIGNIFICANCEThis study introduces a promising method for repairing large annular fissure (AF) defects after disc herniation, combining patch repair with a hydrogel filler. These techniques hold potential for developing clinical AF repair products to address this challenging issue.

Effects of a new continuous nursing program on the short-term and long-term low back pain in patients after UBED: a retrospective study based on 282 patients.

Unilateral biportal endoscopic discectomy (UBED) is a widely accepted minimally invasive surgery for the treatment of lumbar degenerative diseases. However, some patients continue to have persistent low back pain (LBP) symptoms in the short and long term after surgery, which may be related to improper postoperative nursing and rehabilitation of patients. Further research is needed to determine whether continuous nursing can improve the symptoms of patients after UBED. This study retrospectively enrolled 282 lumbar disc herniation (LDH) patients who underwent UBED in our hospital from January 2019 to January 2022. The patients were divided into two groups according to whether they accepted the continuous nursing program: 147 patients in the traditional nursing group and 135 patients in the continuous nursing group. Demographic characteristics, radiological parameters, and follow-up data of the patients were collected. Finally, the risk factors of LBP after UBED were analyzed. The visual analog scale (VAS) score of LBP in the continuous nursing group was 0.97 ± 1.159 at 3 months and 0.61 ± 0.954 at 12 months after operation, and VAS of leg pain was 0.23 ± 0.421 at 12 months after operation, which were better than those in the traditional nursing group (1.51 ± 1.313, 1.10 ± 1.076, 0.68 ± 0.788, respectively, p < 0.001) The Oswestry disability index (ODI) score of the continuous nursing group was lower than that of the traditional nursing group at 12 months after operation (7.36 ± 6.526 vs. 12.43 ± 6.942, p < 0.001). The rehabilitation completion (7.98 ± 1.857), efficacy satisfaction (9.13 ± 1.101), and re-herniation worry scores (1.97 ± 1.217) in the continuous nursing group were better than those in the traditional nursing group (4.14 ± 3.066, 8.28 ± 1.240, 2.79 ± 1.973, respectively, P < 0.001). The re-herniation rate within 1 year was similar between the two groups (3/135 vs. 2/147, p = 0.673). No incision infection occurred. Multivariate regression analysis showed that risk factors for persistent LBP at 3-month follow-up were degenerative disc [odds ratio (OR): 2.144, CI: 1.306-3.519, p = 0.03], Pfirrmann grade (OR: 3.073, CI: 1.427-6.614, p = 0.04), and surgical time (OR: 0.969, CI: 0.937-1.003, p = 0.74). At the 12-month follow-up, the risk factors for persistent LBP were preoperative VAS of the legs (OR: 1.261, CI: 1.000-1.591, p = 0.05) and Pfirrmann grade (OR: 3.309, CI: 1.460-7.496, p = 0.04). Continuous nursing programs can improve the symptoms of short-term and long-term persistent LBP in patients after UBED, enhance the completion of rehabilitation training after UBED, alleviate patients' concerns about recurrence, and improve patients' satisfaction.

Annular Closure Device Reduces Symptomatic Reherniation Rates: Results of a Meta-analysis

Background: The scope of existing annular closure device (ACD) studies examining long-term follow-up data is limited. There is a paucity of studies that report and analyze recent outcomes data following ACD use. Purpose: We sought to summarize the available long-term follow-up data on postoperative outcomes of the Barricaid (Intrinsic Therapeutics) ACD. Methods: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, the PubMed, Cochrane, and OVID databases were searched to identify studies after 2015 that include direct evaluation of an ACD in a clinical context with a minimum of 2 years of follow-up and inclusion of reherniation and complication rates, while excluding case reports, reviews, and meta-analyses. Outcome measures included patient demographics, study characteristics, surgical technique, defect measurement technique, perioperative statistics, radiographic assessments, complications, patient-reported outcome measures (PROMs), and postoperative outcomes. Results: Five studies—2 randomized controlled trials (RCTs), 2 retrospective studies, and 1 prospective cohort study—were included. Symptomatic reherniation rates in the ACD populations ranged from 3% to 18.8%. Two studies found that control groups herniate significantly more than their ACD counterparts (ACD 18.8% vs non-ACD 31.6% and ACD 3.33% vs non-ACD 20.0%). No significant differences were found in reoperation rates. Of the 4 studies that reported PROMs data, all observed relative improvement in each cohort, although pooled analysis did not find significant differences between ACD and non-ACD groups for Oswestry Disability Index and visual analogue scale–leg pain at 2-year follow-up. Conclusions: For patients undergoing diskectomy for lumbar disk herniation, the Barricaid device is effective in reducing symptomatic reherniation but does not appear to alter postoperative PROMs or reoperation rates. Surgeons must consider that device-related complications can occur.

Lumbar Discectomy With Bone-Anchored Annular Closure Device in Patients With Large Annular Defects: One-Year Results.

Reherniation 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. The 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. In 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. Fifty-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. In 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 theRCT, the post-market ACD study demonstrated lower rates of reherniation and/or reoperation and measures of back pain one-year post-surgery.

The effectiveness and safety of annulus closure device implantation in lumbar discectomy for patients with lumbar disc herniation: a systematic review and meta-analysis.

The objective of this study was to systematically estimate the effectiveness and safety of annulus closure device (ACD) implantation in discectomy for patients with lumbar disc herniation (LDH). A systematic search was performed on PubMed, EMBASE and the Cochrane Library for randomized controlled trial (RCT) from inception until April 16, 2022. Trials which investigated comparisons between with and without ACD implantation in discectomy for LDH patients were identified. In total, five RCTs involving 2380 patients with LDH underwent discectomy were included. The included patients were divided into ACD group and control group (CTL). Significant differences were found in the rate of re-herniation (ACD: 7.40%, CTL: 17.58%), reoperation (ACD: 5.39%, CTL: 13.58%) and serious adverse event (ACD: 10.79%, CTL: 17.14%) between ACD group and CTL group. No significant difference was found in VAS-BACK, VAS-LEG, ODI and SF-12 PCS between ACD and CTL. The surgical time of ACD was longer than CTL with statistical significance. In subgroup analyses based on discectomy type, significant differences were found in the rate of re-herniation (ACD: 10.73%, CTL: 21.27%), reoperation (ACD: 4.96%, CTL: 13.82%) and serious adverse event (ACD: 7.59%, CTL: 16.89%) between ACD and CTL in limited lumbar discectomy (LLD). Discectomy either with or without ACD implantation is considered to achieve similar clinical outcomes. Whereas, the ACD implantation in LLD is associated with lower re-herniation and reoperation rate but prolonged surgical time for LDH patients. Researches on cost-effectiveness and effect of ACD implantation in different discectomy are needed in the future.

How I do it: biportal endoscopic paraspinal approach for recurrent lumbar disc herniation following percutaneous endoscopic lumbar discectomy.

Although percutaneous endoscopic lumbar discectomy (PELD) has been popularized as an alternative to microscopic lumbar discectomy, it has been reported to be associated with a re-herniation rate of 5-11%. Recurrent lumbar disc herniation (RLDH) might occur not only at the same level previously operated upon but also at the annular penetration site created during PELD procedures. Biportal endoscopic paraspinal approach (BE-Para) was used for revisional foraminal lumbar discectomy. Procedures and some discussions regarding indications, advantages, potential complications, and ways to avoid complications were described. BE-Para may be an effective modality for RLDH after PELD.

181. Reoperations after primary and revision lumbar discectomy: study of a national level cohort with 8-year follow-up

181. Reoperations after primary and revision lumbar discectomy: study of a national level cohort with 8-year follow-up

What's New in Spine Surgery.

What's New in Spine Surgery.

Lumbar Intervertebral Disc Herniation: Annular Closure Devices and Key Design Requirements.

Lumbar disc herniation is one of the most common degenerative spinal conditions resulting in lower back pain and sciatica. Surgical treatment options include microdiscectomy, lumbar fusion, total disc replacement, and other minimally invasive approaches. At present, microdiscectomy procedures are the most used technique; however, the annulus fibrosus is left with a defect that without treatment may contribute to high reherniation rates and changes in the biomechanics of the lumbar spine. This paper aims to review current commercially available products that mechanically close the annulus including the AnchorKnot® suture-passing device and the Barricaid® annular closure device. Previous studies and reviews have focused mainly on a biomimetic biomaterials approach and have described some mechanical and biological requirements for an active annular repair/regeneration strategy but are still far away from clinical implementation. Therefore, in this paper we aim to create a design specification for a mechanical annular closure strategy by identifying the most important mechanical and biological design parameters, including consideration of material selection, preclinical testing requirements, and requirements for clinical implementation.

Innovative Biological Treatment Methods for Degenerative Disc Disease

Low back pain is the leading cause of work absences and years lived with disability, and it is often associated with degenerative disc disease. In recent years, biological treatment approaches such as the use of growth factors, cell injections, annulus fibrosus (AF) repair, nucleus pulposus replacement, and tissue-engineered discs have been explored as means for preventing or reversing degenerative disc disease. Both animal and clinical studies have shown promising results for cell-based therapy on the grounds of its regenerative potential. Clinical data also indicate that stem cell injection is safe when appropriately performed, albeit its long-term safety and efficacy are yet to be explored. Numerous challenges also remain to be overcome, such as isolating, differentiating, and preconditioning the disc cells, as well as managing the nutrient-deficient and oxygen-deficient micromilieu of the intervertebral disc (IVD). AF repair methods including devices used in clinical trials have shown success in decreasing reherniation rates and improving overall clinical outcomes. In addition, recent studies that combined AF repair and nucleus pulposus replacement have shown improved biomechanical stability in IVDs after the combined treatment. Tissue-engineered IVDs for total disc replacement are still being developed, and future studies are necessary to overcome the challenges in their delivery, efficacy, and safety.

Lumbar Discectomy With Barricaid Device Implantation in Patients at High Risk of Reherniation: Initial Results From a Postmarket Study.

BackgroundPatients with large defects in the annulus fibrosus following lumbar discectomy have high rates of symptomatic reherniation and reoperation. An FDA randomized controlled trial (RCT) with a bone-anchored device (Barricaid, Intrinsic Therapeutics, Woburn, MA) that occludes the annular defect reported significantly lower risk of symptomatic reherniation and reoperation compared to patients receiving discectomy only. However, results of the Barricaid device in real-world use remain limited. MethodsThis was a post-market study to determine the real-world outcomes of the Barricaid device when used in addition to primary lumbar discectomy in patients with large annular defects. Main outcomes included leg pain severity, Oswestry Disability Index (ODI), adverse events, symptomatic reherniation, and reoperation. Imaging studies were read by an independent imaging core laboratory. This paper reports the initial three-month primary endpoint results from the trial; one-year patient follow-up is ongoing.ResultsAmong 55 patients (mean age 41±13 years, 60% male), the mean percent reduction in leg pain severity was 92%, and the mean percent reduction in ODI score was 79%. The three-month rate of symptomatic reherniation was 3.6% and the rate of reoperation was 1.8%. The serious adverse event rate was 5.5%; no device migrations or fractures were observed. ConclusionAmong patients with large annular defects following lumbar discectomy treated with the Barricaid device in real-world conditions, early results demonstrated clinically meaningful improvements in patient symptoms and low rates of symptomatic reherniation, reoperation, and complications, which were comparable to those observed with the device in an FDA-regulated trial.

Clinicians' perceptions around discectomy surgery for lumbar disc herniation: a survey of orthopaedic and neuro-surgeons in Australia and New Zealand.

Understanding practice-based differences in treatment of lumbar disc herniations (LDHs) is vital for reducing unwarranted variation in the delivery of spine surgical health care. Identifying factors that influence surgeons' decision-making will offer useful insights for developing the most cost-effective and safest surgical strategy as well as developing surgeon education materials for common lumbar pathologies. This study was to capture any variation in techniques used by surgeons in Australia and New Zealand (ANZ) region, and perceived complications of different surgical procedures for primary and recurrent LDH (rLDH). Web-based survey study was emailed to orthopaedic and neurosurgeons who routinely performed spinal surgery in ANZ from Decmber 20, 2018 to February 20, 2020. The response data were analyzed to assess for differences based on geography, practice setting, speciality, practice experience, practice length, and operative volume. Invitations were sent to 150 surgeons; 96 (64%) responded. Most surgeons reported microdiscectomy as their surgical technique of choice for primary LDH (73%) and the first rLDH (72%). For the second rLDH, the preferred choice for most surgeons was fusion surgery (82%). A surgeon's practice setting (academic/private/hybrid) was a statistically significant factor in what surgical procedure was chosen for the first rLDH (P = 0.014). When stratifying based on surgeon experience, there were statisfically significant differences based on the annual volume of spine surgeries performed (perceived reherniation rates following primary discectomy, P = 0.013; perceived reherniation rates following revision surgeries, P = 0.017; perceived intraoperative complications rates following revision surgeries, P = 0.016) and based on the annual volume of lumbar discectomies performed (perceived reherniation rates following revision surgeries, P = 0.022; perceived intraoperative complications rates following revision surgeries, P = 0.036; perceived durotomy rates following primary discectomy, P = 0.023). Surgeons' annual practice volume and practice setting have significant influences in the selection of surgical procedures and the perception of surgical complications when treating LDHs.

Long-Term Outcomes in Complex Abdominal Wall Reconstruction Repaired With Absorbable Biologic Polymer Scaffold (Poly-4-Hydroxybutyrate).

After promising early outcomes in the use of absorbable biologic mesh for complex abdominal wall reconstruction, significant criticism has been raised over the longevity of these repairs after its 2-year resorption profile. This is the long-term (5-year) follow-up analysis of our initial experience with the absorbable polymer scaffold poly-4-hydroxybutyrate (P4HB) mesh compared with a consecutive contiguous group treated with porcine cadaveric mesh for complex abdominal wall reconstructions. Our clinical analysis was performed using Stata 14.2 and Excel 16.16.23. After a 5-year follow-up period, the P4HB group (n = 31) experienced lower rates of reherniation (12.9% vs 38.1%; P = 0.017) compared with the porcine cadaveric mesh group (n = 42). The median interval in months to recurrent herniation was similar between groups (24.3 vs 20.8; P = 0.700). Multivariate logistic regression analysis on long-term outcomes identified smoking (P = 0.004), African American race (P = 0.004), and the use of cadaveric grafts (P = 0.003) as risks for complication while smoking (P = 0.034) and the use of cadaveric grafts (P = 0.014) were identified as risks for recurrence. The long-term cost analysis showed that P4HB had a $10,595 per case costs savings over porcine cadaveric mesh. Our study identified the superior outcomes in clinical performance and a value-based benefit of absorbable biologic P4HB scaffold persisted after the 2-year resorption timeframe. Data analysis also confirmed the use of porcine cadaveric grafts independently contributed to the incidence of complications and recurrences.

Putting the Pieces in Place: Mobilizing Cellular Players to Improve Annulus Fibrosus Repair.

The intervertebral disc (IVD) is an integral load-bearing tissue that derives its function from its composite structure and extracellular matrix composition. IVD herniations involve the failure of the annulus fibrosus (AF) and the extrusion of the nucleus pulposus beyond the disc boundary. Disc herniations can impinge the neural elements and cause debilitating pain and loss of function, posing a significant burden on individual patients and society as a whole. Patients with persistent symptoms may require surgery; however, surgical intervention fails to repair the ruptured AF and is associated with the risk for reherniation and further disc degeneration. Given the limitations of AF endogenous repair, many attempts have been made toward the development of effective repair approaches that reestablish IVD function. These methods, however, fail to recapitulate the composition and organization of the native AF, ultimately resulting in inferior tissue mechanics and function over time and high rates of reherniation. Harnessing the cellular function of cells (endogenous or exogenous) at the repair site through the provision of cell-instructive cues could enhance AF tissue regeneration and, ultimately, improve healing outcomes. In this study, we review the diverse approaches that have been developed for AF repair and emphasize the potential for mobilizing the appropriate cellular players at the site of injury to improve AF healing. Impact statement Conventional treatments for intervertebral disc herniation fail to repair the annulus fibrosus (AF), increasing the risk for recurrent herniation. The lack of repair devices in the market has spurred the development of regenerative approaches, yet most of these rely on a scarce endogenous cell population to repair large injuries, resulting in inadequate regeneration. This review identifies current and developing strategies for AF repair and highlights the potential for harnessing cellular function to improve AF regeneration. Ideal cell sources, differentiation strategies, and delivery methods are discussed to guide the design of repair systems that leverage specialized cells to achieve superior outcomes.

Efficacy of a Novel Annular Closure Device after Lumbar Discectomy in Korean Patients : A 24-Month Follow-Up of a Randomized Controlled Trial.

ObjectiveLumbar discectomy is an effective treatment for lumbar disc herniation (LDH); however, up to 2–18% of patients with LDH have experienced recurrent disc herniation. The purpose of this study was to evaluate the efficacy of a novel annular closure device (ACD) for preventing LDH recurrence and re-operation compared with that of conventional lumbar discectomy (CLD). MethodsIn this prospective randomized controlled trial, we compared CLD with discectomy utilizing the Barricaid® (Intrinsic Therapeutics, Inc., Woburn, MA, USA) ACD. Primary radiologic outcomes included disc height, percentage of preoperative disc height maintained, and re-herniation rates. Additional clinical outcomes included visual analog scale (VAS) scores for back and leg pain, Oswestry Disability Index (ODI) scores, and 12-item short-form health survey (SF-12) quality of life scores. Outcomes were measured at preoperation and at 1 week, 1, 3, 6, 12, and 24 months postoperation. ResultsSixty patients (30 CLD, 30 ACD) were enrolled in this study. At 24-month follow-up, the disc height in the ACD group was significantly greater than that in the CLD group (11.4±1.5 vs. 10.2±1.2 mm, p=0.006). Re-herniation occurred in one patient in the ACD group versus six patients in the CLD group (χ2=4.04, p=0.044). Back and leg VAS scores, ODI scores, and SF-12 scores improved significantly in both groups compared with preoperative scores in the first 7 days following surgery and remained at significantly improved levels at a 24-month follow-up. However, no statistical difference was found between the two groups. ConclusionLumbar discectomy with the Barricaid® (Intrinsic Therapeutics, Inc.) ACD is more effective at maintaining disc height and preventing re-herniation compared with conventional discectomy. Our results suggest that adoption of ACD in lumbar discectomy can help improve the treatment outcome.

Pre-operative CT scan measurements for predicting complications in patients undergoing complex ventral hernia repair using the component separation technique

BackgroundThe component separation technique (CST) is considered an excellent technique for complex ventral hernia repair. However, postoperative infectious complications and reherniation rates are significant. Risk factor analysis for postoperative complication and reherniation has focused mostly on patient history and co-morbidity and shows equivocal results. The use of abdominal morphometrics derived from CT scans to assist in risk assessment seems promising. The aim of this study is to determine the predictability of reherniation and surgical site infections (SSI) using pre-operative CT measurements.MethodsElectronic patient records were searched for patients who underwent CST between 2000 and 2013 and had a pre-operative CT scan available. Visceral fat volume (VFV), subcutaneous fat volume (SFV), loss of domain (LOD), rectus thickness and width (RT, RW), abdominal volume, hernia sac volume, total fat volume (TFV), sagittal distance (SD) and waist circumference (WC) were measured or calculated. Relevant variables were entered in multivariate regression analysis to determine their effect on reherniation and SSI as separate outcomes.ResultsSixty-five patients were included. VFV (p = 0.025, OR = 1.65) was a significant predictor regarding reherniation. Hernia sac volume (p = 0.020, OR = 2.10) and SFV per 1000 cm3 (p = 0.034, OR = 0.26) were significant predictors of SSI.ConclusionVisceral fat volume, subcutaneous fat volume and hernia sac volume derived from CT scan measurements may be used to predict reherniation and SSI in patients undergoing complex ventral hernia repair using CST. These findings may aid in optimizing patient-tailored preoperative risk assessment.

Postoperative direct health care costs of lumbar discectomy are reduced with the use of a novel annular closure device in high-risk patients

Lumbar discectomy is largely successful surgical procedure; however, reherniation rates in patients with large annular defects are as high as 27%. The expense associated with a revision surgery places significant burden on the healthcare system. To compare the direct health care costs through 5 years follow-up of conventional discectomy (Control) with those of discectomy supplemented by an adjunctive annular closure device (ACD) in high-risk patients with large annular defects. This was a cost-effectiveness study. All-cause index level reoperations were reviewed from a multicenter, randomized controlled superiority trial that allocated 554 high-risk discectomy patients with large annular defects to either control or ACD. Medicare and private insurer (Humana) direct costs were derived from a commercially available payer database to estimate costs in the US healthcare system, including those associated with facility, surgeon, imaging, follow-up visits, physical therapy, and injections. A 50:50 split between Medicare and commercial insurers was assumed for the base case analysis. The analysis was also performed on a 80:20 commercial:Medicare payer basis. For the base case scenario, a 2-year time horizon and outpatient cost setting was established for the index procedure. Repeat discectomy was assumed to be performed on a 60:40 outpatient-to-inpatient basis. Complications requiring surgery, revisions, and/or fusion were assumed to be managed in the inpatient setting. Total costs of reoperation and per-patient costs of reoperation were compared between groups for both forms of insurers. One author received consulting fees of <$50,000 for the completion of this study, and the other eight authors did not have any financial associations with the current work. Funding for this study was provided by Intrinsic Therapeutics, but all analyses, interpretation, and writing were performed independently by the authors. At two years follow-up, use of the ACD reduced the rate of symptomatic reherniations in a large defect population to 13% compared with 25% in the control group (p<.001). This reduction in symptomatic reherniations in the ACD group translated to a savings of $2,802 per patient in direct health care costs compared with Control at 2 years and $5,315 per patient by 5 years based on 50% private and 50% public (Medicare) payer split. Under the scenario of 80:20 private:public insurance reimbursement, the estimated direct cost savings were $3,215 and $6,099 per patient at 2- and 5-years postoperatively, respectively, with the use of the ACD. Symptomatic reherniation and reoperation rates were nearly double among control patients compared with ACD-treated patients, which translated to markedly greater per-patient healthcare costs in the control group, where the ACD was not used.

Prevention of lumbar reherniation by the intraoperative use of a radiofrequency bipolar device: A case-control study.

Objective:The most common complication after lumbar discectomy is reherniation. Although many studies have investigated factors that may increase the reherniation risk, few are agreed upon all. It has been suggested that limited nucleus removal is associated with higher reherniation risk, while more aggressive nucleus removal can result in increased disc degeneration. Here, we assessed the efficacy of a coblation-assisted microdiscectomy in adult patients undergoing single-level disc surgery.Methods:We prospectively compared the reherniation rate in 75 patients (Group 1) undergoing single-level lumbar disc surgery completed with the radiofrequency bipolar system Aquamantys® (Medtronic, Minneapolis, MN, USA) to that of a historical control group (n = 75) matched for variables related to herniation level and characteristics (Group 2). Patients were followed up to 4 years. Reherniations were assessed, pain and function were monitored throughout, and imaging was performed at annual follow-up.Results:The overall symptomatic reherniation rate was 4%. In particular, one case (1.3%) was observed in Group 1 and five (6.7%) in Group 2 (P < 0.05). Magnetic resonance imaging identified a total of 4 (2.7%) asymptomatic reherniations at 12 months, 6 (4%) at 24 and 36 months, and 7 (4.7%) at 48 months. Overall, Group 1 contained one (1.3%) asymptomatic reherniation case, while six (8%) were observed in Group 2 (P < 0.05).Conclusions:The low reherniation rate in patients treated by the coblation-assisted microdiscectomy suggests that this technique may reduce the reherniation risk. Clinical outcomes for pain and function at 4 years follow-up compared favorably with literature data. Randomized controlled trial could confirm these results.

Implantation of a bone-anchored annular closure device in conjunction with tubular minimally invasive discectomy for lumbar disc herniation: a retrospective study

BackgroundMinimally invasive techniques for lumbar discectomy have been recommended as superior to open techniques due to lower blood loss, lower rates of infection and shorter recovery. There are, however, concerns that this approach does not sufficiently remove the herniated nuclear material, thus leaving the patient susceptible to reherniation requiring reoperation. The purpose of this study was to examine the safety and viability of an annular closure device in limiting reherniation and reoperation in a cohort of patients undergoing minimally invasive lumbar discectomy with the assistance of an annular closure device.MethodsWe retrospectively analysed the results from patients treated by a single surgeon between March 2011 and December 2017. All patients had been diagnosed with a large (≥ 5 mm) defect and were treated via minimally invasive surgical techniques. Outcomes included demographic data, the procedural duration and the rates of symptomatic reherniation and reoperation.Results60 patients were included in the study. The mean age was 42 years (range: 19–66); mean BMI was 24.1 (range: 16.7–36.3). Mean surgical duration was 29 min (range: 16–50). Reoperation was required in 5% (3/60) of patients, although only 3% (2/60) experienced symptomatic reherniation at the index level. No other complications were reported.ConclusionsIn our study, the use of an annular closure device during minimally invasive lumbar discectomy in a population of patients with large herniations was associated with low rates of reherniation and reoperation at the index level. While more research is required, the results of this study demonstrate the safety and viability of the annular closure device as an adjunct to minimally invasive discectomy.

Effectiveness of an annular closure device in a &amp;ldquo;real-world&amp;rdquo; population: stratification of registry data using screening criteria from a randomized controlled trial

PurposeIncreased focus has been put on the use of “‘real-world” data to support randomized clinical trial (RCT) evidence for clinical decision-making. The objective of this study was to assess the performance of an annular closure device (ACD) after stratifying a consecutive series of “real-world” patients by the screening criteria of an ongoing RCT.Materials and methodsThis was a single-center registry analysis of 164 subjects who underwent limited discectomy combined with ACD for symptomatic lumbar disc herniation. Patients were stratified into two groups using the selection criteria of a pivotal RCT on the same device: Trial (met inclusion; n=44) or non-Trial (did not meet inclusion; n=120). Patient-reported outcomes, including Oswestry Disability Index (ODI) and visual analog scale (VAS) for leg and back pain, and adverse events were collected from baseline to last follow-up (mean: Trial – 15.6 months; non-Trial – 14.6 months). Statistical analyses were performed with significance set at p<0.05.ResultsPatient-reported outcomes were not significantly different between groups at last (p≥0.15) and clinical success (≥15-point improvement in ODI score; ≥20-point improvement in VAS scores) was achieved in both the groups. Three non-Trial (2.5%) and three Trial (6.8%) patients experienced symptomatic reherniation (p=0.34). Rates of reoperation, ACD mesh dislocation/separation, and other radiographic findings were similar between groups (p=1.00).ConclusionOutcomes with the ACD appeared advantageous in both the groups, particularly in comparison with historical reherniation rates reported in the same high-risk, large annular defect population. Stratification of this “real-world” series on the basis of RCT screening criteria did not result in significant between-group differences. These findings suggest that the efficacy of the ACD extends beyond the strictly defined patient population being studied in the RCT of this device. Furthermore, reducing the reherniation rate following lumbar discectomy has positive clinical and economic implications.