Annular Closure Research Articles

113. Lumbar discectomy patients who undergo reoperation experience worse clinical outcomes and greater socioeconomic burden four years after the primary procedure

BACKGROUND CONTEXT Multiple studies have observed that the clinical outcomes of patients who have undergone revision surgery after lumbar discectomy are less positive than outcomes in patients who did not require revision. Lumbar disc herniation patients with large annular defects undergoing discectomy are at significantly greater risk for symptom recurrence and revision, indicating that this population is also at significantly greater risk for worse clinical outcomes. The goal of this analysis was to assess the clinical and socioeconomic outcomes associated with post-discectomy reoperations and the utility of a bone-anchored annular closure device (ACD) for avoiding reoperations in patients with large annular defects. PURPOSE Not applicable. STUDY DESIGN/SETTING Not applicable. PATIENT SAMPLE Not applicable. OUTCOME MEASURES Not applicable. METHODS This was a retrospective analysis of a prospective randomized controlled trial (RCT). Lumbar discectomy patients with large (≥6 mm) annular defects were randomized to treatment with limited discectomy alone (Control; n=278) or limited discectomy augmented by an annular closure device (ACD; n=272). Clinical outcomes included visual analog scale (VAS) for ipsilateral leg and back pain, Oswestry Disability Index (ODI), reoperations at the index-level, serious adverse events (SAE), and working status. Comparisons of clinical and socioeconomic outcomes were made between reoperated and nonreoperated patients, regardless of ACD or Control treatment, at 4 years following the primary surgery. RESULTS At 4 years, clinical outcomes data were available for 73% of the patients. Among patients with data at 4 years, 64 experienced at least one index-level reoperation (Reoperated group) and 340 were not reoperated (Non-reoperated group). The Kaplan-Meier estimate of subjects experiencing at least one index-level reoperation within 48 months was 14.4% in the ACD group and 21.1% in the Control group (p=0.03 log-rank). In all, 49 procedures were performed in ACD subjects and 77 procedures performed in Control subjects. The reoperated patients had significantly worse scores than non-reoperated patients for ODI (22 ± 16 vs 11 ± 13; p CONCLUSIONS Index-level reoperations following lumbar discectomy in patients with large annular defects are associated with worse clinical outcomes and greater socioeconomic burden. These findings are consistent with reports on outcomes from large registry analyses including the Spine Patient Outcomes Research Trial (SPORT) and the Swedish National Spine Registry (Swespine). The ACD was effective in minimizing the number of patients subject to revision, primarily through prevention of repeat discectomy, with 33% fewer patients undergoing at least one index-level reoperation. FDA DEVICE/DRUG STATUS Barricaid Annular Closure Device (ACD) - (Approved for this indication).

The experience of surgical treatment of lumbar disc herniation in adolescents using annuloplasty: analysis of a small clinical series

Objective . To assess feasibility, safety and effectiveness of a device for annular defect closure in surgical elimination of radicular compression syndrome in adolescents with degenerative disc disease. Material and Methods . Five 11–17-year-old patients underwent disc hernia removal and root decompression followed by annuloplasty with a Barricaid implant in 2012–2016. Clinical and radiological (CT, MRI) techniques were used to assess the pain intensity on VAS, the degree of intervertebral disk degeneration according to Pfirrmann, the orientation of the facet joints and the cartilaginous surface, and the severity of sclerosis. The long-term follow-up period averaged 57 months (from 40 to 62 months). Surgical results were evaluated in accordance with the modified MacNub scale at 3 months and 3 years after surgery. Results . In all cases, surgery had positive clinical effect with complete relief of the pain syndrome, including complete regression of distal paresis of the lower limb. In all patients, the 3-month result of surgery was rated on the MasNub scale as good and 3-year result – as excellent. The position of implants was stable, with no signs of further disc degeneration and decrease in interbody space. Conclusion . Closure of the annular defect after lumbar microdisectomy provides excellent long-term results in adolescents with radicular compression syndrome associated with herniated discs. However, convincing and reliable assessment of the method requires further studies with a comparative analysis using sufficient clinical material.

Predictors of Treatment Success Following Limited Discectomy With Annular Closure for Lumbar Disc Herniation.

Previous studies have demonstrated bone-anchored annular closure to significantly reduce reherniation and reoperation rates after lumbar discectomy in patients with large annular defects. It is important to identify the prognostic factors that may be associated with successful treatment. This study aimed to identify predictors of treatment success in patients with lumbar disc herniation treated with limited microdiscectomy supplemented by a bone-anchored annular closure device (ACD). This study was a retrospective analysis of 133 consecutive patients with lumbar disc herniation treated with the ACD. Treatment success was defined as ≥24% improvement in visual analog scale (VAS) for back pain, ≥39% improvement in VAS leg pain, and ≥33% in the Oswestry Disability Index (ODI), with the raw ODI score ≤48. Success was calculated at 3, 6, and 12 months after surgery. Potentially predictive outcomes included patient characteristics, operative data, and imaging outcomes, such as disc, facet, and end plate morphology. Logistic regression was used to determine the significant predictive factors for treatment success. After 3, 6, and 12 months, 97 of 131 (74%), 104 of 129 (81%), and 112 of 126 (89%) patients, respectively, achieved the success criteria. At 3 months follow-up, a higher proportion of younger (17-40 years) versus older (41-65 years) patients met the success criteria (P = .025). On the basis of logistic regression, the following factors were significantly associated with treatment success at 1 or more of the follow-up time points: sex (male), lower body mass index, higher baseline pain and ODI scores, lower grade preoperative disc degeneration, and the absence of a postoperative complication. The rates of index-level recurrent herniation and reoperation were 1.5% and 3.0%, respectively. This real-world evidence supports a promising benefit-risk profile for augmenting limited microdiscectomy with a bone-anchored ACD and provides some insights into the patient populations that may have a greater chance of realizing significant improvements in pain and function. 2 (Cohort study).

International Society for the Advancement of Spine Surgery Policy 2019-Surgical Treatment of Lumbar Disc Herniation with Radiculopathy.

Lumbar disc herniation (LDH) is a frequent cause of low back pain and radiculopathy, disability, and diminution in quality of life. While nonsurgical care remains the mainstay of initial treatment, symptoms that persist for prolonged periods of time are well treated with discectomy surgery. A large body of evidence shows that, in patients with unremitting symptoms despite a reasonable period of nonsurgical treatment, discectomy surgery is safe and efficacious. In patients with symptoms lasting greater than 6 weeks, various forms of discectomy (open, microtubular, and endoscopic) are superior to continued nonsurgical treatment. The small but significant proportion of patients with recurrent disc herniation experience less improvement overall than patients who do not experience reherniation after primary discectomy. Lumbar discectomy patients with large annular defects (≥6 mm wide) are at a higher risk for recurrent herniation and revision surgery. Annular closure via a bone-anchored device has been shown to decrease the rate of recurrent disc herniation and associated reoperation in these high-risk patients. After a detailed review of the literature, current clinical evidence supports discectomy (open, microtubular, or endoscopic discectomy) as a medically necessary procedure for the treatment of LDH with radiculopathy in indicated patients. Furthermore, there is new scientific evidence that supports the use of bone-anchored annular closure in patients with large annular defects, who are at greater risk for recurrent disc herniation.

Needle-Guided Suture Technique for Lumbar Annular Fiber Closure in Microendoscopic Discectomy: A Technical Note and Case Series.

BackgroundAnnular fiber closure techniques have been proven effective in reducing short-term recurrence after discectomy. However, annular fiber closure devices are expensive and still fail at a low rate. We present a novel suture method, needle-guided annular closure suture (NGACS) that does not require a special device and can be performed for annular fiber closure following microendoscopic discectomy.Material/MethodsTwenty-five patients who underwent treatment with NGACS were reviewed by analysis of the medical records. The clinical outcomes were assessed and compared preoperatively and immediately, 1, 6, and 12 months postoperatively. The parameters included the Visual Analog Scale (VAS)-back and VAS-leg scores and the Oswestry Disability Index (ODI). Midsagittal T2WI images were obtained to evaluate lumbar disc degeneration using the Pfirrmann grade. Additional adverse events were also recorded and tracked.ResultsThe VAS-back and VAS-leg scores and the ODI were significantly different at each follow-up time point (P<0.001), and improvements in pain and disability were maintained well during the follow-up period. Lumbar disc reherniation or other serious adverse events were not observed in this series. There was no significant difference between the initial and final Pfirrmann grades (Z=−1.414, P=0.157). The preoperative average disc height was 9.94±1.97 mm, and the disc height at 12 months after surgery was 9.14±1.88 mm. The average decrease in disc height was 8.11±3.36%.ConclusionsThis study demonstrates the feasibility and superior clinical outcomes of the NGACS technique. This method can be a good substitution when annular fiber closure devices are not available. Moreover, this technique can be easily popularized due to its low cost and few restrictions.

Lumbar disc reherniation prevention with a bone-anchored annular closure device

Background:The risk of recurrent herniation after lumbar discectomy is highest during the first postoperative year. The purpose of this study was to determine whether implantation of a bone-anchored annular closure device (ACD) following limited lumbar discectomy reduced the risk of recurrent herniation and complications during the first year of follow-up compared to limited lumbar discectomy alone (Controls) and whether this risk was influenced by patient characteristics.Methods:In this randomized multicenter trial, patients with symptomatic lumbar disc herniation and with a large annular defect following limited lumbar discectomy were randomized to bone-anchored ACD or Control groups. The risks of symptomatic reherniation, reoperation, and device- or procedure-related serious adverse events were reported over 1 year of follow-up.Results:Among 554 patients (ACD 276; Control 278), 94% returned for 1-year follow-up. Bone-anchored ACD resulted in lower risks of symptomatic reherniation (8.4% vs. 17.3%, P = .002) and reoperation (6.7% vs. 12.9%, P = .015) versus Controls. Device- or procedure-related serious adverse events through 1 year were reported in 7.1% of ACD patients and 13.9% of Controls (P = .009). No baseline patient characteristic significantly influenced these risks.Conclusions:Among patients with large annular defects following limited lumbar discectomy, additional implantation with a bone-anchored ACD lowered the risk of symptomatic reherniation and reoperation over 1 year follow-up. Device- or procedure-related serious adverse events occurred less frequently in the ACD group. These conclusions were not influenced by patient characteristics. ClinicalTrials.gov (NCT01283438).

Does Patient Blinding Influence Clinical Outcomes After Annular Closure Device Implantation? A Propensity Score-Matched Analysis.

BackgroundAwareness of treatment group assignment in a clinical trial may influence patient behavior and bias outcome reporting. The objective of this study was to compare 2-year clinical outcomes in blinded vs unblinded patients who were treated with lumbar discectomy and a bone-anchored annular closure device (ACD) for prevention of lumbar disc reherniation.MethodsThis was a secondary analysis of a randomized trial comparing lumbar discectomy with (n=272) vs without (n=278) implantation of a bone-anchored ACD. Among patients who received ACD implantation, 35 (13%) were blinded and 237 (87%) were unblinded to treatment allocation. In patients treated with ACD, propensity score-matching (1:1) was performed to account for imbalances in patient characteristics between blinded and unblinded groups. Key clinical outcomes were back pain severity (0–100 scale), leg pain severity (0–100 scale), Oswestry Disability Index (ODI, 0–100 scale), symptomatic reherniation, reoperation at the treated lumbar level, and device- or procedure-related serious adverse events (AEs). Outcomes were reported through 2 years of follow-up, which coincided with the time at which blinded patients were unblinded.ResultsThere were no statistically significant differences in 2-year outcomes between propensity score-matched blinded (n=35) and unblinded (n=35) patients treated with the ACD. In blinded vs unblinded ACD patients compared to baseline, back pain severity decreased by 40 vs 37 points (P=0.61), leg pain severity decreased by 75 points in each group (P>0.99), and ODI decreased by 47 vs 43 points (P=0.19). The risks of symptomatic reherniation (5.7% vs 9.1%; P=0.59), reoperation (8.6% vs 12.2%, P=0.62), and device- or procedure-related serious AEs (5.7% vs 8.9%, P=0.63) were comparably low in blinded and unblinded patients.ConclusionIn patients treated with lumbar discectomy and a bone-anchored ACD, there were no clinically important or statistically significant differences in back pain, leg pain, ODI, symptomatic reherniation, reoperation, or serious AEs over 2 years of follow-up when comparing patients who were blinded vs unblinded to their treatment assignment. The main limitations of this study were the post hoc nature of the analysis and the potential for bias due to surgeon awareness of treatment assignment.

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.

Annular closure device lowers reoperation risk 4 years after lumbar discectomy.

ObjectiveTo determine whether implanting an annular closure device (ACD) following a lumbar discectomy procedure in patients with large defects in the annulus fibrosus lowers the risk of reoperation after 4 years.MethodsIn a multicenter randomized trial, patients with large annular defects following single-level lumbar discectomy were intraoperatively randomized to additionally receive an ACD or no treatment (Controls). Clinical and imaging follow-up were performed at routine intervals over 4 years of follow-up. Main outcomes included reoperations at the treated lumbar level, leg pain scores on a visual analog scale, Oswestry Disability Index (ODI), and Physical Component Summary (PCS) and Mental Component Summary (MCS) scores from the SF-36 questionnaire.ResultsAmong 550 patients (ACD 272, Control 278), the risk of reoperation over 4 years was 14.4% with ACD and 21.1% with Controls (P=0.03). The reduction in reoperation risk with ACD was not significantly influenced by patient age (P=0.51), sex (P=0.34), body mass index (P=0.21), smoking status (P=0.85), level of herniation (P=0.26), leg pain severity at baseline (P=0.90), or ODI at baseline (P=0.54). All patient-reported outcomes improved in each group from baseline to 4 years (all P<0.001). The percentage of patients who achieved the minimal clinically important difference without a reoperation was proportionally higher in the ACD group compared to Controls for leg pain (P=0.07), ODI (P=0.10), PCS (P=0.02), and MCS (P=0.06).ConclusionThe addition of a bone-anchored ACD following lumbar discectomy in patients with large post-surgical annular defects reduces the risk of reoperation and provides better long-term pain and disability relief over 4 years compared to lumbar discectomy only.

Reoperations Following Lumbar Discectomy Are Associated With Worse Clinical Outcomes and Greater Socioeconomic Burden 3 Years After the Primary Procedure

Abstract INTRODUCTION Lumbar discectomy patients with large annular defects are at significantly greater risk for symptom recurrence and revision. Previous studies suggest that outcomes following revision surgery are less positive than outcomes from primary discectomy. This analysis aimed to assess the clinical and socioeconomic outcomes associated with postdiscectomy reoperations and the utility of a bone-anchored annular closure device (ACD) for avoiding reoperations. METHODS This study was a retrospective analysis of a prospective randomized controlled trial (RCT). Lumbar discectomy patients with large (&gt;6 mm) annular defects were treated with discectomy alone (Control; n = 278) or discectomy with an ACD (n = 272). Patient-reported outcomes included visual analog scale (VAS) for ipsilateral leg or back pain and Oswestry Disability Index (ODI). At 3 yr, clinical outcomes were available for 75% of the patients. Comparisons of outcomes were made between reoperated (n = 64) and nonreoperated (n = 351) patients, regardless of ACD or Control treatment, at 3 yr following the primary surgery. RESULTS Reoperated patients had significantly worse scores for ODI (24 ± 19 vs 11 ± 13; P &lt; .0001), VAS leg pain (28 ± 30 vs 12 ± 19; P &lt; .0001), and VAS back pain (36 ± 31 vs 17 ± 21; P &lt; .0001). Significantly more nonreoperated patients were working at 3 yr (97% vs 84%; P &lt; .001). Based on Kaplan-Meier analysis, the proportion of subjects experiencing at least 1 index-level reoperation in 3 yr was 11% in the ACD group and 19% in the Control group (P = .007). CONCLUSION Index-level reoperations following lumbar discectomy are associated with worse outcomes and greater socioeconomic burden in patients with large annular defects (&gt;6 mm). These findings are consistent with reports from large registry analyses, including the Spine Patient Outcomes Research Trial (SPORT) and the Swedish National Spine Registry (Swespine). The ACD reduced the number of patients experiencing index-level reoperation by 43%.

Reoperations After First Lumbar Disk Herniation Surgery with or without Implantation of Mechanical Annular Closure Device

Reoperations After First Lumbar Disk Herniation Surgery with or without Implantation of Mechanical Annular Closure Device

Reoperation After Primary Lumbar Discectomy with or without Implantation of a Bone-Anchored Annular Closure Device: Surgical Strategies and Clinical Outcomes

To determine whether presence of a bone-anchored annular closure device (ACD) impacts reoperation strategies and subsequent outcomes. Patients with large annular defects after single-level limited lumbar discectomy were randomly allocated to receive an ACD or discectomy alone (controls) and were followed for at least 3 years. Among 550 patients, reoperation risk was lower with ACD (11.0% vs. 19.3%). The types of reoperations and operative time were similar in each group, and the ACD did not interfere with surgical planning or operative technique. Fusion success was 87% with ACD versus 85% for controls. Perioperative complications occurred in 22% and 19% of reoperations, respectively. Leg pain and back function were improved with ACD versus controls after fusion procedures, and no groupdifferences were observed after non-fusion reoperations. In patients undergoing post-discectomy reoperation, patients with an ACD were treated with similar operative techniques, were not exposed to additional surgical risks, and reported comparable clinical outcomes versus those without an ACD.

Two-year real-world results of lumbar discectomy with bone-anchored annular closure in patients at high risk of reherniation

To determine the safety and effectiveness of limited lumbar discectomy with additional implantation of an annular closure device (ACD) among patients at high risk of herniation recurrence treated in routine clinical practice. This was a prospective, single-center study of lumbar discectomy for sciatica caused by intervertebral disc herniation with adjunctive ACD implantation to reduce herniation recurrence risk among high-risk patients with large annular defects. Patients returned for follow-up visits at 6weeks, 12weeks, 26weeks, 1year, and 2years. Main outcomes included reoperation, herniation recurrence, back pain severity, leg pain severity, and Oswestry Disability Index (ODI). The minimum important difference was defined as ≥ 20mm decrease relative to baseline for leg pain severity, ≥ 20mm decrease for back pain severity, and ≥ 15-point decrease for ODI. Among 75 high-risk patients (mean age 45years, 59% female), the cumulative event incidence through 2years was 4.0% for reoperation and 1.4% for herniation recurrence. Mean leg pain severity decreased from 73 to 6 (p < 0.001), back pain severity decreased from 51 to 13 (p < 0.001), and ODI decreased from 49 to 7 (p < 0.001). The percentage of patients achieving the minimum important difference was 91% for leg pain, 65% for back pain, and 94% for ODI. In patients at high risk of herniation recurrence following limited lumbar discectomy in routine clinical practice, additional implantation of an ACD was safe and reherniation recurrence rates were low at 2-year follow-up, which is favorably compared to reported rates in high-risk patients.

Study of Lumbar Discectomy With Annular Closure

Study of Lumbar Discectomy With Annular Closure

Clinical performance of a bone-anchored annular closure device in older adults.

Background: Lumbar discectomy is a common surgical procedure in middle-aged adults. However, outcomes of lumbar discectomy among older adults are unclear.Methods: Lumbar discectomy patients with an annular defect ≥6 mm width were randomized to receive additional implantation with a bone-anchored annular closure device (ACD, n=272) or no additional implantation (controls, n=278). Over 3 years follow-up, main outcomes were symptomatic reherniation, reoperation, and the percentage of patients who achieved the minimum clinically important difference (MCID) without a reoperation for leg pain, Oswestry Disability Index (ODI), SF-36 Physical Component Summary (PCS) score, and SF-36 Mental Component Summary (MCS) score. Results were compared between older (≥60 years) and younger (<60 years) patients. We additionally analyzed data from two postmarket ACD registries to determine consistency of outcomes between the randomized trial and postmarket, real-world results.Results: Among all patients, older patients suffered from crippling or bed-bound preoperative disability more frequently than younger patients (57.9% vs 39.1%, p=0.03). Among controls, female sex, higher preoperative ODI, and current smoking status, but not age, were associated with greater risk of reherniation and reoperation. Compared to controls, the ACD group had lower risk of symptomatic reherniation (HR=0.45, p<0.001) and reoperation (HR=0.54, p=0.008), with risk reductions comparable in older vs younger patients. The percentage of patients achieving the MCID without a reoperation was higher in the ACD group for leg pain (81% vs 72%, p=0.04), ODI (82% vs 73%, p=0.03), PCS (85% vs 75%, p=0.01), and MCS (59% vs 46%, p=0.007), and this benefit was comparable in older versus younger patients. Comparable benefits in older patients were observed in the postmarket ACD registries.Conclusion: Outcomes with lumbar discectomy and additional bone-anchored ACD are superior to lumbar discectomy alone. Older patients derived similar benefits with additional bone-anchored ACD implantation as younger patients.

Three-year results from a randomized trial of lumbar discectomy with annulus fibrosus occlusion in patients at high risk for reherniation

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

Who benefits from medical technical innovations? : Amedical and medical economic analysis using the example of lumbar disc surgery

Further developments in disease diagnosis and treatment are of immense relevance for advancements in medical care of the population. A detailed cost-benefit analysis of direct and indirect costs is usually unavailable. In the current article, these aspects are investigated using prospectively collected randomized data over two years. Specifically, the surgical treatment of a herniated lumbar disc is addressed, and whether a newly introduced technique (e.g., annular closure device) can lead to a better quality of care and increased patient satisfaction when performed during the standard operation, while also being economically viable.

Closing the Treatment Gap for Lumbar Disc Herniation Patients with Large Annular Defects: A Systematic Review of Techniques and Outcomes in this High-risk Population.

Lumbar disc herniation (LDH) is one of the most common spinal pathologies and can be associated with debilitating pain and neurological dysfunction. Discectomy is the primary surgical intervention for LDH and is typically successful. Yet, some patients experience recurrent LDH (RLDH) after discectomy, which is associated with worse clinical outcomes and greater socioeconomic burden. Large defects in the annulus fibrosis are a significant risk factor for RLDH and present a critical treatment challenge. It is essential to identify reliable and cost-effective treatments for this at-risk population. A systematic review of the PubMed and Embase databases was performed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines to identify studies describing the treatment of LDH patients with large annular defects. The incidence of large annular defects, measurement technique, RLDH rate, and reoperation rate were compiled and stratified by surgical technique. The risk of bias was scored for each study and for the identification of RLDH and reoperation. Study heterogeneity and pooled estimates were calculated from the included articles. Fifteen unique studies describing 2,768 subjects were included. The pooled incidence of patients with a large annular defect was 44%. The pooled incidence of RLDH and reoperation following conventional limited discectomy in this population was 10.6% and 6.0%, respectively. A more aggressive technique, subtotal discectomy, tended to have lower rates of RLDH (5.8%) and reoperation (3.8%). However, patients treated with subtotal discectomy reported greater back and leg pain associated with disc degeneration. The quality of evidence was low for subtotal discectomy as an alternative to limited discectomy. Each report had a high risk of bias and treatments were never randomized. A recent randomized controlled trial with 550 subjects examined an annular closure device (ACD) and observed significant reductions in RLDH and reoperation rates (>50% reduction). Based on the available evidence, current discectomy techniques are inadequate for patients with large annular defects, leaving a treatment gap for this high-risk population. Currently, the strongest evidence indicates that augmenting limited discectomy with an ACD can reduce RLDH and revision rates in patients with large annular defects, with a low risk of device complications.

Annular closure device reduces costs in lumbar discectomy

Annular closure device reduces costs in lumbar discectomy

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.