Efficacy of a Novel Annular Closure Device after Lumbar Discectomy in Korean Patients : A 24-Month Follow-Up of a Randomized Controlled Trial
| Autor: | Gyu Yeul Ji, Dong Ah Shin, Sang Hyuk Park, Pyung Goo Cho |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Discectomy
medicine.medical_specialty Visual analogue scale Lumbar discectomy medicine.medical_treatment 030218 nuclear medicine & medical imaging law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Quality of life law Barricaid medicine Clinical Article business.industry General Neuroscience Spine Surgery Oswestry Disability Index Disc height Intervertebral disc disease Herniated disc Neurology (clinical) business 030217 neurology & neurosurgery Month follow up |
| Zdroj: | Journal of Korean Neurosurgical Society |
| ISSN: | 1598-7876 2005-3711 |
| DOI: | 10.3340/jkns.2019.0071 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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