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Efficacy of a Novel Annular Closure Device After Lumbar Discectomy in Korean Patients : A 24-Month Follow-Up of a Randomized Controlled Trial

Authors
 Pyung Goo Cho  ;  Dong Ah Shin  ;  Sang Hyuk Park  ;  Gyu Yeul Ji 
Citation
 JOURNAL OF KOREAN NEUROSURGICAL SOCIETY, Vol.62(6) : 691-699, 2019-11 
Journal Title
 JOURNAL OF KOREAN NEUROSURGICAL SOCIETY 
ISSN
 2005-3711 
Issue Date
2019-11
Keywords
Intervertebral disc disease ; Discectomy ; Herniated disc ; Barricaid
Abstract
Objective: Lumbar discectomy is an effective treatment for lumbar disc herniation (LDH); however, up to 2-18% of patients with LDH have experienced recurrent disc herniation. The purpose of this study was to evaluate the efficacy of a novel annular closure device (ACD) for preventing LDH recurrence and re-operation compared with that of conventional lumbar discectomy (CLD). Methods: In this prospective randomized controlled trial, we compared CLD with discectomy utilizing the Barricaid® (Intrinsic Therapeutics, Inc., Woburn, MA, USA) ACD. Primary radiologic outcomes included disc height, percentage of preoperative disc height maintained, and re-herniation rates. Additional clinical outcomes included visual analog scale (VAS) scores for back and leg pain, Oswestry Disability Index (ODI) scores, and 12-item short-form health survey (SF-12) quality of life scores. Outcomes were measured at preoperation and at 1 week, 1, 3, 6, 12, and 24 months postoperation. Results: Sixty patients (30 CLD, 30 ACD) were enrolled in this study. At 24-month follow-up, the disc height in the ACD group was significantly greater than that in the CLD group (11.4±1.5 vs. 10.2±1.2 mm, p=0.006). Re-herniation occurred in one patient in the ACD group versus six patients in the CLD group (χ2=4.04, p=0.044). Back and leg VAS scores, ODI scores, and SF-12 scores improved significantly in both groups compared with preoperative scores in the first 7 days following surgery and remained at significantly improved levels at a 24-month follow-up. However, no statistical difference was found between the two groups. Conclusion: Lumbar discectomy with the Barricaid® (Intrinsic Therapeutics, Inc.) ACD is more effective at maintaining disc height and preventing re-herniation compared with conventional discectomy. Our results suggest that adoption of ACD in lumbar discectomy can help improve the treatment outcome.
Files in This Item:
T201906313.pdf Download
DOI
10.3340/jkns.2019.0071
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Neurosurgery (신경외과학교실) > 1. Journal Papers
Yonsei Authors
Shin, Dong Ah(신동아) ORCID logo https://orcid.org/0000-0002-5225-4083
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/175852
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