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      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

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          Abstract

          Introduction

          Lumbar 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.

          Methods

          This 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.

          Results

          A 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%).

          Conclusion

          Post-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).

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          Most cited references40

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          Surgical versus nonoperative treatment for lumbar disc herniation: four-year results for the Spine Patient Outcomes Research Trial (SPORT).

          Concurrent, prospective, randomized, and observational cohort study. To assess the 4-year outcomes of surgery versus nonoperative care. Although randomized trials have demonstrated small short-term differences in favor of surgery, long-term outcomes comparing surgical to nonoperative treatment remain controversial. Surgical candidates with imaging-confirmed lumbar intervertebral disc herniation meeting SPORT eligibility criteria enrolled into prospective, randomized (501 participants), and observational cohorts (743 participants) at 13 spine clinics in 11 US states. Interventions were standard open discectomy versus usual nonoperative care. Main outcome measures were changes from baseline in the SF-36 Bodily Pain (BP) and Physical Function (PF) scales and the modified Oswestry Disability Index (ODI - AAOS/Modems version) assessed at 6 weeks, 3 months, 6 months, and annually thereafter. Nonadherence to treatment assignment caused the intent-to-treat analyses to underestimate the treatment effects. In the 4-year combined as-treated analysis, those receiving surgery demonstrated significantly greater improvement in all the primary outcome measures (mean change surgery vs. nonoperative; treatment effect; 95% CI): BP (45.6 vs. 30.7; 15.0; 11.8 to 18.1), PF (44.6 vs. 29.7; 14.9;12.0 to 17.8) and ODI (-38.1 vs. -24.9; -13.2; -15.6 to -10.9). The percent working was similar between the surgery and nonoperative groups, 84.4% versus 78.4% respectively. In a combined as-treated analysis at 4 years, patients who underwent surgery for a lumbar disc herniation achieved greater improvement than nonoperatively treated patients in all primary and secondary outcomes except work status.
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            Clinical outcomes after lumbar discectomy for sciatica: the effects of fragment type and anular competence.

            The surgical treatment of sciatica with discectomy is ineffective in a sizable percentage of patients, and reherniation occurs after 5% to 15% of such procedures. The purpose of the present study was to determine if competence of the disc anulus and the type of herniation could be used to predict postoperative clinical outcomes following lumbar discectomy. A prospective observational study of 187 consecutive patients undergoing single-level primary lumbar discectomy was conducted. A single surgeon performed all of the procedures, and an independent examiner evaluated 180 of the patients clinically at a minimum of two and a median of six years after surgery. The extent of anular deficiency and the presence of disc fragments were determined. On the basis of these intraoperative findings, disc herniations were classified into four categories: (1) Fragment-Fissure herniations (eighty-nine patients), (2) Fragment-Defect herniations (thirty-three patients), (3) Fragment-Contained herniations (forty-two patients), and (4) No Fragment-Contained herniations (sixteen patients). The effects of disc herniation morphology and preoperative variables on subsequent clinical outcome were determined with the Student t test for continuous variables and chi-square analysis for categorical variables. Patients in the Fragment-Fissure group, who had disc fragments and a small anular defect, had the best overall outcomes and the lowest rates of reherniation (1%) and reoperation (1%). Patients in the Fragment-Contained group had a 10% rate of reherniation and a 5% rate of reoperation. Patients in the Fragment-Defect group, who had extruded fragments and massive posterior anular loss, had a 27% rate of reherniation and a 21% rate of reoperation. Patients in the No Fragment-Contained group did poorly: 38% had recurrent or persistent sciatica, and the standard outcomes scores were less improved compared with those in the other groups (p < 0.001). Intraoperative findings, as described in the present study, were more clearly associated with outcomes than were demographic, socioeconomic, or clinical variables. The degree of anular competence after discectomy and the type of herniation appear to have value for the prediction of the recurrence of sciatica, reoperation, and clinical outcome following lumbar discectomy. Prognostic study, Level I-1 (prospective study). See p. 2 for complete description of levels of evidence.
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              Recurrent disc herniation and long-term back pain after primary lumbar discectomy: review of outcomes reported for limited versus aggressive disc removal.

              It remains unknown whether aggressive disc removal with curettage or limited removal of disc fragment alone with little disc invasion provides a better outcome for the treatment of lumbar disc herniation with radiculopathy. We reviewed the literature to determine whether outcomes reported after limited discectomy (LD) differed from those reported after aggressive discectomy (AD) with regard to long-term back pain or recurrent disc herniation. A systematic MEDLINE search was performed to identify all studies published between 1980 and 2007 reporting outcomes after AD or LD for a herniated lumbar disc with radiculopathy. The incidence of short- and long-term recurrent back or leg pain and recurrent disc herniation was assessed from each reported LD or AD cohort and the cumulative incidence compared. Fifty-four studies (60 discectomy cohorts) met the inclusion criteria, reporting the outcomes of 13 359 patients after lumbar discectomy (LD, 6135 patients; AD, 7224 patients). The reported incidence of short-term recurrent back or leg pain was similar after LD (mean, 14.5%; range, 7-16%) and AD (mean, 14.1%; range, 6-43%) (P < 0.01). However, more than 2 years after surgery, the reported incidence of recurrent back or leg pain was 2.5-fold less after LD (mean, 11.6%; range, 7-16%) compared with AD (mean, 27.8%; range, 19-37%) (P < 0.0001). The reported incidence of recurrent disc herniation after LD (mean, 7%; range, 2-18%) was greater than that reported after AD (mean, 3.5%; range, 0-9.5%) (P < 0.0001). Review of the literature demonstrates a greater reported incidence of long-term recurrent back and leg pain after AD but a greater reported incidence of recurrent disc herniation after LD. Prospective, randomized trials are needed to firmly assess this possible difference.
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                Author and article information

                Journal
                Clinicoecon Outcomes Res
                Clinicoecon Outcomes Res
                ClinicoEconomics and Outcomes Research
                ClinicoEconomics and Outcomes Research: CEOR
                Dove Medical Press
                1178-6981
                2018
                26 June 2018
                : 10
                : 349-357
                Affiliations
                [1 ]Department of Neurosurgery, St. Bonifatius Hospital, Lingen, Germany
                [2 ]Department of Orthopaedic Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA
                [3 ]Department of Neurosurgery, OLV Ziekenhuis, Aalst, Belgium
                [4 ]Telos Partners LLC, Denver, CO, USA, jinzana@ 123456telospartnersllc.com
                [5 ]Neurochirurgisch Centrum Zwolle, Zwolle, the Netherlands
                [6 ]Neurosurgical Spine Service, Brigham and Women’s Hospital, Boston, MA, USA
                [7 ]Department of Neurosurgery, Innsbruck Medical University, Innsbruck, Austria
                Author notes
                Correspondence: Jason Inzana, Telos Partners LLC, 4484 Hamilton Ct., Boulder, Denver, CO 80305, USA, Tel +1 720 256 7036, Email jinzana@ 123456telospartnersllc.com
                Article
                ceor-10-349
                10.2147/CEOR.S164129
                6027694
                483f01dc-fdae-4dc7-91ea-25d906a7c00b
                © 2018 Klassen et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                History
                Categories
                Original Research

                Economics of health & social care
                lumbar discectomy,annular closure device,patient-reported outcomes,direct costs,reherniation,reoperation

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