Annular closure device lowers reoperation risk 4 years after lumbar discectomy.

Abstract

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<0.001). The percentage of patients who achieved the minimal clinically important difference without a reoperation was proportionally higher in the ACD group compared to Controls for leg pain (P=0.07), ODI (P=0.10), PCS (P=0.02), and MCS (P=0.06).

CONCLUSION:

The addition of a bone-anchored ACD following lumbar discectomy in patients with large post-surgical annular defects reduces the risk of reoperation and provides better long-term pain and disability relief over 4 years compared to lumbar discectomy only.

• Authors: Dharmin Nanda, Mark P Arts, Larry E Miller, Hans-Peter Köhler, Jason M Perrin, Charlotte Flüh, Peter Vajkoczy
• Journal: Medical devices (Auckland, N.Z.) (Med Devices (Auckl)) Vol. 12 Pg. 327-335 ( 2019) ISSN: 1179-1470 [Print] New Zealand
• PMID: 31564999 (Publication Type: Journal Article)
• Copyright: © 2019 Nanda et al.