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Study Citation Patient Population Study Design Sample Size Follow-Up Results Klassen et al 201720 a Radiculopathy + imaging confirmed LDH + failed ≥6 wk of NS care; large annular defect (≥6 mm); mean ages were 43 (22–71) y (AC) and 44 (23–74) y (D) RCT D: 278 AC: 272 90 d Significantly lower rate of all-cause SAEs (9.7% vs 16.3 %; P = 0.056) and device- or surgery-related SAEs (4.5% vs 10.2%; P = 0.02) with AC compared with D; reoperation rate at 90 d was 5.4% with D and 1.9% with AC (P = 0.03); device dislocation occurred in 0.7% of AC patients. Van den Brink et al 201929 a Same study populations and parameters as Klassen et al 1 y Significantly lower rates of symptomatic index-level rLDH (8.4% AC vs 17.3% D, P = 0.002); reoperation (6.7% AC vs 12.9% D, P = 0.015); and device- or surgery-related SAEs (7.1% AC vs 13.9% D, P = 0.009). Thome et al 201827 a Same study populations and parameters as Klassen et al 2 y Frequency of symptomatic index-level rLDH (12% vs 25%; P < 0.001), composite success index (27% vs 18%; P = 0.02), and device or procedure-related SAEs (7% vs 17%; P = 0.001) significantly improved with AC compared with D; reoperation rate was 13% in D and 5% in the AC groups (P = 0.001); device migration and mesh migration occurred in 1.1% and 1.5% of AC patients, respectively. Kienzler et al 201919 a Same study populations and parameters as Klassen et al 3 y Symptomatic index-level rLDH rate (14.8% vs 29.5%; P < 0.001), reoperation rate (11% 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), physical health component (47 vs 44; P < 0.01), and mental health component (52 vs 49; P < 0.01) scores were significantly improved with AC compared with D; reoperation rate was 19.3% with D and 11% with AC (P = 0.007); all-cause SAE rate was reduced in the AC group (10.7% vs 18.7%; P = 0.008); device-related deficiencies and fracture occurred in 4% and 0.4% of AC patients, respectively. Nanda et al 201923 a Same study populations and parameters as Klassen et al 4 y Over 4 years, reoperation rate was significantly lower in AC group (14.4% vs 21.1%; P = 0.03); partial or complete device removal in 23 reoperations; no reoperations were related to endplate changes; magnitude of improvement was greater in AC patients for leg pain (P = 0.04), ODI (P = 0.04), and mental health component scores (P = 0.02). Thome et al 202128 a Same study populations and parameters as Klassen et al 5 y AC exhibited statistically significant reductions in symptomatic index-level rLDH (18.8% vs 31.6%; P < 0.001), reoperation (16.0% vs 22.6%; P = 0.03), and device- or surgery-related SAEs (12.0% vs 20.0%, P = 0.008) compared with D; clinically significant improvements in leg pain severity, ODI, and health-related QOL were observed over 5 years with no clinically relevant differences between AC and D; reoperation for device failure was 5.2%; Vertebral endplate changes were more common in AC with no association with clinical outcomes (leg pain, ODI, and health-related QOL). Cho et al 201918 Radiculopathy + radiographically confirmed LDH; mean ages 41 ± 11 y (AC) and 43 ± 12 y (D) RCT D: 30 and AC: 30 2 y Significantly greater disc height maintenance (86.3% vs 79.2%; P = 0.04) in AC vs D group; rate of rLDH was 20% in D and 3.3% in AC groups (P = 0.04); no instances of device migration, loosening, or fracture occurred in AC group. Nunley et al 202324 Radiculopathy + radiographically confirmed LDH; failed ≥6 wk NS care; large annular defect (≥6 mm); mean age 41 ± 13 y (AC) Prospective cohort AC: 55 1 y rLDH and reoperation rates were 3.7% and 5.5%, respectively; no device-related SAEs or device integrity failures observed; 4 SAEs observed (hematoma, reherniation, infection, and neurological function decline); 97.1% of patients returned to work by 1 y (median 2.5 wk). Ardeshiri et al 201917 Symptomatic, MRI-confirmed LDH at single level; disc height ≥5 mm; annular defect ≥6 mm; mean age 45 (23–82) y Prospective cohort AC: 75 2 y rLDH rate was 1.4% (1/75); 3 reoperations (4%) required: rLDH, epidural infection, and device dislocation;1 intraoperative implant-associated dural tear occured but did not result in postoperative complications; improper implantation of 1 device in 1 patient, but no associated AEs noted. Sanginov et al 201826 Symptomatic LDH confirmed by CT or MRI + failed 6 wk of NS care; mean age of 38 (17–63) y Prospective cohort AC: 120 5 y 1 ipsilateral (0.8%) and 1 contralateral (0.8%) rLDH (both reoperated); other reoperations included 3 fusions for segmental instability and treatment of 1 epidural hematoma; Modic endplate changes in 20 patients (16.7%) at baseline and 42 (35%) within 5 y of follow-up; no significant differences in pain or function scores between patients with or without endplate changes Kursumovic et al 201721 Radiculopathy + radiographically confirmed LDH; 90% with annular defect ≥6 mm; mean age 46 (18–75) y Real-world registry analysis AC: 171 15 mo Mean follow-up of 15 (1–72) mo; 74% had 12 mo or later follow-up. Six (3.5%) reherniations, 4 of which required reoperation; 22 reoperations were performed across 12 patients (7%), which included 5 fusions, 5 re-discectomies, 4 wound revisions, 3 decompressions, 2 spinal cord stimulators, and 3 unknown; device-related complications in 15 patients (8.8%), 2 of whom required revision surgery. Vukas et al 201330 Radiculopathy + failed ≥6 wk of NS care + preoperative MRI; mean ages 38 y (AC) and 41 y (D) (18–70 for all) Prospective comparative cohorts D: 72 and AC: 30 2 y Improved leg pain (8.9 vs 21.2; P = 0.005), back pain (10.5 vs 19.1; P = 0.27), and disability (11.6 vs 19.8; P = 0.08) with AC compared to D at 2-y follow-up; symptomatic reherniation rate was 6.9% in D and 0% in AC groups; patients were enrolled nonconcurrently; no instances of device-related AEs Sanginov et al 202425 Radiculopathy + LDH confirmed by MRI + large annular defect (≥6 mm); median age 38 y (AC) Consecutive case series AC: 133 8 y rLDH rate was 1.5%, and reoperation rate was 3.0% at 1 y; after 1 y, symptomatic and asymptomatic rLDH were 2.8% and 1.9%; bone resorption was observed in 64% of patients, primarily around the polymer barrier. By 8 years, all resorption stabilized and/or decreased as evidenced by sclerotic rims; maximum resorbed bone volume was 12%. Presence and size of bone resorption had no clinical impact. Lequin et al 201222 Sciatica with MRI-confirmed LDH + failed ≥6 wk of NS care; Mean age 42 ± 11 y; mean defect width 7.8 mm Prospective cohort AC: 45 1 y Of 41 patients, symptomatic rLDH in 1 (2.4%), who also required a reoperation; 3 total reoperations (6.7%): ipsilateral rLDH, contralateral rLDH, and scar tissue management; no evidence of heterotopic ossification or spontaneous fusion and no device complications observed. Abbreviations: AC, annular closure; AE, adverse events;CT, computed tomography; D, discectomy group; LDH, lumbar disc herniation; MRI, magnetic resonance imaging; NS, nonsurgical;ODI, Oswestry Disability Index; QOL, quality of life; RCT, randomized controlled trial; rLDH, recurrent lumbar disc herniation; SAE, serious adverse events.
↵a These studies report 90-d, 1-y, 2-y, 3-y, 4-y, and 5-y follow-up time points and outcomes of the same RCT.
Diagnosis Code Code Descriptor M51 Thoracic, thoracolumbar, and lumbosacral intervertebral disc disorders M51.0 With myelopathy M51.1 With radiculopathy M51.2 Other thoracic, thoracolumbar, and lumbosacral intervertebral disc displacement M51.3 Other thoracic, thoracolumbar, and lumbosacral intervertebral disc degeneration M51.8 Other thoracic, thoracolumbar, and lumbosacral intervertebral disc disorders M51.9 Unspecified thoracic, thoracolumbar, and lumbosacral intervertebral disc disorder M51.A0 Intervertebral annulus fibrosus defect, unspecified size, and lumbar region M51.A1 Intervertebral annulus fibrosus defect, small, and lumbar region M51.A2 Intervertebral annulus fibrosus defect, large, and lumbar region M51.A3 Intervertebral annulus fibrosus defect, unspecified size, and lumbosacral region M51.A4 Intervertebral annulus fibrosus defect, small, and lumbosacral region M51.A5 Intervertebral annulus fibrosus defect, large, and lumbosacral region M48.00 Spinal stenosis and site unspecified M48.05 Spinal stenosis and thoracolumbar region M48.06 Spinal stenosis and lumbar region M48.07 Spinal stenosis and lumbosacral region M48.08 Spinal stenosis, sacral, and sacrococcygeal region M47.1 Other spondylosis with myelopathy M47.2 Other spondylosis with radiculopathy Abbreviations: CPT, current procedural terminology; ICD-10-CM, International Classification of Diseases, 10th Revision, Clinical Modification.
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- Isass Policy Statement and Coverage Rationale: Lumbar Discectomy with Bone-Anchored Annular Closure
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