Expert review of medical devices · 2020
Expert review with meta-analysis of randomized and nonrandomized controlled studies of Barricaid annular closure in patients at high risk for lumbar disc reherniation.
СтатьяМетаанализСистематический обзорНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Miller Larry E, Allen R Todd, Duhon Brad, Radcliff Kris E
Аннотация
Introduction: Patients with lumbar disc herniation and associated sciatica are often referred for lumbar discectomy. The surgical defect in the annulus fibrosus is typically left unrepaired after lumbar discectomy. Patients with large postsurgical annular defects (≥6 mm width) have a higher risk of symptom recurrence and reoperation compared to those with small defects. In these high-risk patients, a treatment gap exists due to the lack of effective treatments for durable annulus fibrosus repair.Areas covered: This article highlights the therapeutic need and summarizes the clinical results of a bone-anchored annular closure device (Barricaid) that was designed to fill the treatment gap in patients with large postsurgical annular defects. Clinical results were summarized by means of a systematic review with meta-analysis of two randomized and two nonrandomized controlled studies.Expert opinion: Professional societal recommendations and clinical study results support the adoption of bone-anchored annular closure for use in properly selected patients undergoing lumbar discectomy who are at high-risk for reherniation due to a large postsurgical defect in the annulus fibrosus. The risks of symptomatic reherniation and reoperation are approximately 50% lower in patients treated with lumbar discectomy and the Barricaid device compared to lumbar discectomy only, representing a clinically effective treatment strategy.