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

摘要

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.