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Objective To 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. Methods In 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. Results Among 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

Supplemental Digital Content is available in the text, Study design: Systematic review with network meta-analysis. Objective: To compare patient outcomes of lumbar discectomy with bone-anchored annular closure (LD + AC), lumbar discectomy (LD), and continuing conservative care (CC) for treatment of lumbar disc herniation refractory to initial conservative management. Summary of background data: Several treatment options are available to patients with refractory symptoms of lumbar disc herniation, but their comparative efficacy is unclear. Methods: A systematic review was performed to compare efficacy of LD + AC, LD, and CC for treatment of lumbar disc herniation. Outcomes included leg pain, back pain, disability (each reported on a 0–100 scale), reherniation, and reoperation. Data were analyzed using random effects network meta-analysis. Results: This review included 14 comparative studies (8 randomized) involving 3947 patients—11 studies of LD versus CC (3232 patients), 3 studies of LD + AC versus LD (715 patients), and no studies of LD + AC versus CC. LD was more effective than CC in reducing leg pain (mean difference [MD] −10, P

Background: Same-level reherniation and progressive degeneration with disc height loss are main causes of poor outcome after discectomy and may necessitate reoperation. A novel prosthesis for anular closure was developed to address these causes.Methods: The design of a multicenter, prospective, randomized, post-market superiority trial comparing limited lumbar discectomy augmented with this device (intervention group) with limited lumbar discectomy alone (control group) is presented.Results: Patients with single-level (L1-S1) posterior or posterolateral disc herniation and radiologic confirmation of neural compression for whom at least six weeks of conservative treatment has failed are eligible. Patients must have posterior disc height ≥5 mm at index level and baseline Oswestry and VAS leg pain scores of ≥40/100. Intraoperatively, subjects meeting anular defect size criteria post-discectomy (4-6 mm tall and 6-10 mm wide) will be randomized to study groups in a 1:1 ratio using centralized, web-based software. A Bayesian statistical approach will be used to enroll 400 to 800 subjects who will be followed for at least 24 months. Two co-primary endpoints will be assessed at 24 months: 1) a composite of leg pain, clinical function, disc height maintenance, and absence of reherniation, reoperation, and device failure; and 2) absence of reherniation based upon independent radiologic analysis. Conclusions: This type of analysis is becoming increasingly important as governments and health insurers continue to be pressured to spend limited healthcare funding wisely.