Abstract
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
Highlights
Lumbar discectomy is an effective surgery for chronic sciatica secondary to intervertebral disc herniation
Results from case series [4, 11, 12, 15] and a recent randomized trial [17] with this device have demonstrated clinically important reductions in reherniation and reoperation rates through 2 years. We extend these findings by presenting 3-year results from a randomized trial of 554 patients who received lumbar discectomy with bone-anchored annular closure or lumbar microdiscectomy only
In this randomized trial of high-risk patients, implantation with a bone-anchored annular closure device (ACD) following limited lumbar discectomy reduced the risk of reherniation and reoperation and achieved a better long-term pain and disability relief with associated higher levels of health-related quality of life compared with lumbar discectomy only
Summary
Lumbar discectomy is an effective surgery for chronic sciatica secondary to intervertebral disc herniation. An implantable device intended to provide a more durable repair has been developed This annular closure device (ACD) anchors into the adjacent vertebral body and occludes the damaged annulus fibrosus with a polymer mesh. We extend these findings by presenting 3-year results from a randomized trial of 554 patients who received lumbar discectomy with bone-anchored annular closure or lumbar microdiscectomy only. A 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
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