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

摘要: OBJECTIVE Lumbar discectomy is an effective treatment for lumbar disc herniation (LDH); however, up to 2-18% of patients with LDH have experienced recurrent herniation. The purpose this study was evaluate the efficacy a novel annular closure device (ACD) preventing recurrence and re-operation compared that conventional (CLD). METHODS In prospective randomized controlled trial, we CLD utilizing Barricaid® (Intrinsic Therapeutics, Inc., Woburn, MA, USA) ACD. Primary radiologic outcomes included height, percentage preoperative height maintained, re-herniation rates. Additional clinical visual analog scale (VAS) scores back leg pain, Oswestry Disability Index (ODI) scores, 12-item short-form health survey (SF-12) quality life scores. Outcomes were measured at preoperation 1 week, 1, 3, 6, 12, 24 months postoperation. RESULTS Sixty (30 CLD, 30 ACD) enrolled in study. At 24-month follow-up, ACD group significantly greater than (11.4±1.5 vs. 10.2±1.2 mm, p=0.006). Re-herniation occurred one patient versus six (χ2=4.04, p=0.044). Back VAS ODI SF-12 improved both groups first 7 days following surgery remained levels follow-up. However, no statistical difference found between two groups. CONCLUSION Inc.) more maintaining discectomy. Our results suggest adoption can help improve outcome.