Annular closure device may reduce recurrence, reoperation of lumbar disc herniation
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Published results showed lumbar microdiscectomy with a bone-anchored annular closure device for treatment of lumbar disc herniation and large annular defect may reduce the risk of symptomatic recurrence and reoperation at 5-year follow-up.
Researchers randomly assigned 554 patients with lumbar disc herniation and a large annular defect to undergo either lumbar microdiscectomy alone or with an additional bone-anchored annular closure device (Barricaid, Intrinsic Therapeutics). Researchers compared the incidence of symptomatic reherniation, reoperation and adverse events, and changes in leg pain, Oswestry Disability Index (ODI) and health-related quality of life (HRQoL) between the two groups during 5 years of follow-up.
Overall, 550 patients were included in the modified intent-to-treat efficacy population and the as-treated safety population. Results showed patients in the device group had lower risks of symptomatic reherniation (18.8% vs. 31.6%) and reoperation (16% vs. 22.6%) compared with the control group. Researchers found 40 patients in the device group underwent 53 reoperations and 58 patients in the control group underwent 82 reoperations. In the 5 years of follow-up, researchers noted a significant improvement in scores for leg pain severity, ODI and HRQoL with no clinically relevant differences between groups. The two groups had comparable frequency of serious adverse events, but patients in the device group had less frequent serious adverse events associated with the device or procedure, according to results.
“These findings support the use of an annular closure device during lumbar discectomy procedures when the intraoperatively identified defect in the annulus is greater than 6 mm width, which places the patient at elevated risk for a future lumbar disc reherniation,” the authors wrote.
Perspective
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I read this publication from the Annular Closure RCT Study Group with interest as it details extended follow-up on their investigation of a novel bone-anchored annular closure device. As an orthopedic spine surgeon, microdiscectomy is among our most common procedures and is generally associated with favorable outcomes. Despite refinements of surgical approach and technique, however, there continues to exist a persistent incidence of reoperation, with many of those reoperations due to symptomatic recurrent disc herniation. While this incidence is commonly considered low, studies have identified a high-risk subgroup of discectomy patients with large annular defects and preserved disc height for whom the risk of symptomatic reherniation is as high as 18% to 27%. Regardless of the risk stratification, patients frequently inquire not only as to overall success rates, but also whether as surgeons we “do anything to fix the hole.”
Previously published outcomes of patients treated with this annular closure device have been encouraging. This large, prospective study provides us with important information on longer-term device survivorship, as well as effectiveness of annular closure, significantly reducing both symptomatic reherniation and reoperation.
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