Large Annular Defects Research Articles

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.

Effectiveness of an Annular Closure Device to Prevent Recurrent Lumbar Disc Herniation

Patients with large annular defects following lumbar microdiscectomy for disc herniation are at increased risk for symptomatic recurrence and reoperation.To determine whether a bone-anchored annular closure device in addition to lumbar microdiscectomy resulted in lower reherniation and reoperation rates vs lumbar microdiscectomy alone.This secondary analysis of a multicenter randomized clinical trial reports 5-year follow-up for enrolled patients between December 2010 and October 2014 at 21 clinical sites. Patients in this study had a large annular defect (6-10 mm width) following lumbar microdiscectomy for treatment of lumbar disc herniation. Statistical analysis was performed from November to December 2020.Lumbar microdiscectomy with additional bone-anchored annular closure device (device group) or lumbar microdiscectomy only (control group).The incidence of symptomatic reherniation, reoperation, and adverse events as well as changes in leg pain, Oswestry Disability Index, and health-related quality of life when comparing the device and control groups over 5 years of follow-up.Among 554 randomized participants (mean [SD] age: 43 [11] years; 327 [59%] were men), 550 were included in the modified intent-to-treat efficacy population (device group: n = 272; 270 [99%] were White); control group: n = 278; 273 [98%] were White) and 550 were included in the as-treated safety population (device group: n = 267; control group: n = 283). The risk of symptomatic reherniation (18.8% [SE, 2.5%] vs 31.6% [SE, 2.9%]; P < .001) and reoperation (16.0% [SE, 2.3%] vs 22.6% [SE, 2.6%]; P = .03) was lower in the device group. There were 53 reoperations in 40 patients in the device group and 82 reoperations in 58 patients in the control group. Scores for leg pain severity, Oswestry Disability Index, and health-related quality of life significantly improved over 5 years of follow-up with no clinically relevant differences between groups. The frequency of serious adverse events was comparable between the treatment groups. Serious adverse events associated with the device or procedure were less frequent in the device group (12.0% vs 20.5%; difference, -8.5%; 95% CI, -14.6% to -2.3%; P = .008).In patients who are at high risk of recurrent herniation following lumbar microdiscectomy owing to a large defect in the annulus fibrosus, this study's findings suggest that annular closure with a bone-anchored implant lowers the risk of symptomatic recurrence and reoperation over 5 years of follow-up.ClinicalTrials.gov Identifier: NCT01283438.

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.

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).

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.

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).

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%.

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.

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

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.

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.

Challenges in the Analysis of Longitudinal Pain Data: Practical Lessons from a Randomized Trial of Annular Closure in Lumbar Disc Surgery.

Purpose. To analyze leg pain severity data from a randomized controlled trial (RCT) of lumbar disc surgery using integrated approaches that adjust pain scores collected at scheduled follow-up visits for confounding clinical events occurring between visits. Methods. Data were derived from an RCT of a bone-anchored annular closure device (ACD) following lumbar discectomy versus lumbar discectomy alone (Control) in patients with large postsurgical annular defects. Leg pain was recorded on a 0 to 100 scale at 6 weeks, 3 months, 6 months, 1 year, and 2 years of follow-up. Patients with pain reduction ≥20 points relative to baseline were considered responders. Unadjusted analyses utilized pain scores reported at follow-up visits. Since symptomatic reherniation signifies clinical failure of lumbar discectomy, integrated analyses adjusted pain scores following a symptomatic reherniation by baseline observation carried forward for continuous data or classification as nonresponders for categorical data. Results. Among 550 patients (272 ACD, 278 Control), symptomatic reherniation occurred in 10.3% of ACD patients and in 21.9% of controls (p < 0.001) through 2 years. There was no difference in leg pain scores at the 2-year visit between ACD and controls (12 versus 14; p = 0.33) in unadjusted analyses, but statistically significant differences favoring ACD (19 versus 29; p < 0.001) in integrated analyses. Unadjusted nonresponder rates were 6.0% with ACD and 6.7% with controls (p = 0.89), but 15.7% and 27.8% (p = 0.001) in integrated analyses. The probability of nonresponse was 16.4% with ACD and 18.3% with controls (p = 0.51) in unadjusted analysis, and 23.7% and 31.2% (p = 0.04) in integrated analyses. Conclusion. In an RCT of lumbar disc surgery, an integrated analysis of pain severity that adjusted for the confounding effects of clinical failures occurring between follow-up visits resulted in different conclusions compared to an unadjusted analysis of pain scores reported at follow-up visits only.

Reduction of direct costs in high-risk lumbar discectomy patients during the 90-day post-operative period through annular closure.

PurposeDespite being an extremely successful procedure, recurrent disc herniation is one of the most common post-discectomy complications in the lumbar spine and contributes significant health care and socioeconomic costs. Patients with large annular defects are at a high risk for reherniation, but an annular closure device (ACD) has been designed to reduce reherniation risk in this population and may, in turn, help control direct health care costs after discectomy.Patients and methodsThis analysis examined the 90-day post-discectomy cost estimates among ACD-treated (n=272) and control (discectomy alone; n=278) patients in a randomized controlled trial (RCT). Direct medical costs were estimated based on 2017 Humana and Medicare claims. Index discectomies were assumed to occur in an outpatient (OP) setting, whereas repeat discectomies were assumed to be 60% in OP and 40% in inpatient (IP). A sensitivity analysis was performed on this assumption. The device cost was not included in the analysis in order to focus on costs in the 90-day post-operative period.ResultsWithin 90 days of follow-up, post-operative complications occurred in 3.3% of the ACD patients and 8.6% of the control patients (P=0.01). The average 90-day cost to treat an ACD patient was $10,257 compared to $11,299 per control patient for a 80:20 distribution of Commercial:Medicare coverage ($1,042 difference). This difference varied from $687 with 100% Medicare to $1,132 with 100% Commercial coverage. Varying the IP vs OP distribution resulted in a cost difference range of $968 to $1,156 with the ACD.ConclusionAugmenting discectomy with an ACD in high-risk patients with a large annular defect reduced reherniation and reoperation rates, which translated to a reduction of direct health care costs between $687 and $1,156 per patient during the 90-day post-operative period. Large annular defect patients are an easily identifiable high-risk population. Operative strategies that reduce complication risks in these patients, such as the ACD, could be advantageous from both patient care and economic perspectives.

Morphology and Clinical Relevance of Vertebral Endplate Changes Following Limited Lumbar Discectomy With or Without Bone-anchored Annular Closure.

Post hoc analysis of a randomized controlled trial. To characterize the morphology and clinical relevance of vertebral endplate changes (VEPC) following limited lumbar discectomy with or without implantation of a bone-anchored annular closure device (ACD). Implantation of an ACD following limited lumbar discectomy has shown promise in reducing the risk of recurrent herniation in patients with large annular defects. However, the interaction between the ACD and the lumbar endplate over time is not well understood. Patients undergoing limited lumbar discectomy with large postsurgical annular defects were randomized intraoperatively to receive additional ACD implantation or limited lumbar discectomy only (Controls). VEPC morphology, area, and volume were assessed with low-dose computed tomography preoperatively and at 1 and 2 years follow-up. Of 554 randomized patients, the as-treated population consisted of 550 patients (267 ACD, 283 Controls). VEPC were preoperatively identified in 18% of patients in the ACD group and in 15% of Controls. At 2 years, VEPC frequency increased to 85% with ACD and 33% in Controls. Device- or procedure-related serious adverse event (8% vs. 17%, P = 0.001) and secondary surgical intervention (5% vs. 13%, P < 0.001) favored the ACD group over Controls. In the ACD group, clinical outcomes were comparable in patients with and without VEPC at 2 years follow-up. In the Control group, patients with VEPC at 2 years had higher risk of symptomatic reherniation versus patients without VEPC (35% vs. 19%, P < 0.01) CONCLUSION.: In patients with large annular defects following limited lumbar discectomy, additional implantation with a bone-anchored ACD reduces risk of postoperative complications despite a greater frequency of VEPC. VEPC were associated with higher risk of symptomatic reherniation in patients treated with limited lumbar discectomy, but not in those who received additional ACD implantation. 2.

Post-lumbar discectomy reoperations that are associated with poor clinical and socioeconomic outcomes can be reduced through use of a novel annular closure device: results from a 2-year randomized controlled trial

IntroductionLumbar discectomy patients with large annular defects are at a high risk for reherniation and reoperation, which could be mitigated through the use of an annular closure device (ACD). To identify the most effective treatment pathways for this high-risk population, it is critical to understand the clinical outcomes and socioeconomic costs among reoperated patients as well as the utility of ACD for minimizing reoperation risk.MethodsThis was a post hoc analysis of a prospective, multicenter, randomized controlled trial (RCT) designed to investigate the safety and efficacy of an ACD. All 550 patients (both ACD treated and control) from the RCT with follow-up data through 2 years were included in this analysis (69 reoperated and 481 non-reoperated). Reoperations were defined as any revision surgery of the index level, regardless of indication. Equivalent U.S. Medicare expenditures for reoperations were estimated through cost multipliers derived from the commercially available PearlDiver database.ResultsA significantly greater number of control patients (45/278; 16%) compared to ACD patients (24/272; 9%) underwent a revision surgery at the index level within 2 years of followup (p=0.01). At 2 years of follow-up, the reoperated patients had significantly worse Oswestry Disability Index scores and visual analog scale for leg and back pain scores compared to their non-reoperated counterparts (p<0.0001). The total estimated direct medical costs for reoperation were US $952,348 ($13,802 per reoperated patient), with control patients accounting for the majority of this cost burden ($565,188; 59%).ConclusionPost-discectomy reoperation is associated with significantly increased patient morbidity, missed work, and direct treatment costs in a population at high risk for reherniation. Annular closure helped minimize this clinical and socioeconomic burden by reducing the incidence of reoperation by nearly 50% (16% control vs 9% ACD).

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.

Annular closure in lumbar microdiscectomy for prevention of reherniation: a randomized clinical trial

Background ContextPatients with large annular defects after lumbar discectomy for disc herniation are at high risk of symptomatic recurrence and reoperation. PurposeThe present study aimed to determine whether a bone-anchored annular closure device, in addition to lumbar microdiscectomy, resulted in lower reherniation and reoperation rates plus increased overall success compared with lumbar microdiscectomy alone. DesignThis is a multicenter, randomized superiority study. Patient SamplePatients with symptoms of lumbar disc herniation for at least 6 weeks with a large annular defect (6–10 mm width) after lumbar microdiscectomy were included in the study. Outcome MeasuresThe co-primary end points determined a priori were recurrent herniation and a composite end point consisting of patient-reported, radiographic, and clinical outcomes. Study success required superiority of annular closure on both end points at 2-year follow-up. MethodsPatients received lumbar microdiscectomy with additional bone-anchored annular closure device (n=276 participants) or lumbar microdiscectomy only (control; n=278 participants). This research was supported by Intrinsic Therapeutics. Two authors received study-specific support morethan $10,000 per year, 8 authors received study-specific support less than $10,000 per year, and 11 authors received no study-specific support. ResultsAmong 554 randomized participants, 550 (annular closure device: n=272; control: n=278) were included in the modified intent-to-treat efficacy analysis and 550 (annular closure device: n=267; control: n=283) were included in the as-treated safety analysis. Both co-primary end points of the study were met, with recurrent herniation (50% vs. 70%, P<.001) and composite end point success (27% vs. 18%, P=.02) favoring annular closure device. The frequency of symptomatic reherniation was lower with annular closure device (12% vs. 25%, P<.001). There were 29 reoperations in 24 patients in the annular closure device group and 61 reoperations in 45 control patients. The frequency of reoperations to address recurrent herniation was 5% with annular closure device and 13% in controls (P=.001). End plate changes were more prevalent in the annular closure device group (84% vs. 30%, P<.001). Scores for back pain, leg pain, Oswestry Disability Index, and health-related quality of life at regular visits were comparable between groups over 2-year follow-up. ConclusionsIn patients at high risk of herniation recurrence after lumbar microdiscectomy, annular closure with a bone-anchored implant lowers the risk of symptomatic recurrence and reoperation. Additional study to determine outcomes beyond 2 years with a bone-anchored annular closure device is warranted.