Yamada Katsuhisa, Kenichiro Maeda, Ito Yoichi M, Inage Fujio, Isoe Toshiyuki, Yokota Nozomi, Sugita Osamu, Sato Norihiro, Tha Khin Khin, Iwasaki Norimasa, Arato Teruyo, Sudo Hideki
Department of Orthopaedic Surgery, Hokkaido University Hospital, N14W5, Sapporo, Japan.
Department of Orthopaedic Surgery, Faculty of Medicine, and Graduate School of Medicine, Hokkaido University, N15W7, Sapporo, Hokkaido, 060-8638, Japan.
Contemp Clin Trials Commun. 2021 Jun 29;23:100805. doi: 10.1016/j.conctc.2021.100805. eCollection 2021 Sep.
Herniated nucleus pulposus (NP), one of the most common diseases of the spine, is surgically treated by removing the sequestered NP. However, intervertebral disc (IVD) defects may remain after discectomy, leading to inadequate tissue healing and predisposing patients to IVD degeneration. An acellular, bioresorbable, ultra-purified alginate (UPAL) gel (dMD-001) implantation system can be used to fill any IVD defects in order to prevent IVD degeneration after discectomy. This first-in-human pilot study aims to determine the feasibility, safety, and perceived patient response to a combined treatment involving discectomy and UPAL gel implantation for herniated NP. We designed a one-arm, double-centre, open-label, pilot trial. The study started in November 2018 and will run until a sample of 40 suitable participants is established. Patients aged 20-49 years, diagnosed with isolated lumbar IVD herniation and scheduled for discectomy represent suitable candidates. All eligible participants who provide informed consent undergo standard discectomy followed by UPAL gel implantation. The primary outcomes of the trial will be the feasibility and safety of the procedure. Secondary outcomes will include self-assessed clinical scores and magnetic resonance imaging-based measures of morphological and compositional quality of the IVD tissue. Initial outcomes will be published at 24 weeks. Analysis of feasibility and safety will be performed using descriptive statistics. Both intention-to-treat and per-protocol analyses of treatment trends of effectiveness will be conducted.
髓核突出（NP）是脊柱最常见的疾病之一，通过手术切除游离的NP进行治疗。然而，椎间盘切除术（髓核摘除术）后可能会残留椎间盘（IVD）缺损，导致组织愈合不充分，并使患者易患IVD退变。一种无细胞、可生物吸收、超纯化的藻酸盐（UPAL）凝胶（dMD - 001）植入系统可用于填充任何IVD缺损，以防止椎间盘切除术后的IVD退变。这项首次人体试验性研究旨在确定髓核突出患者接受椎间盘切除术联合UPAL凝胶植入的联合治疗的可行性、安全性以及患者的感受。我们设计了一项单臂、双中心、开放标签的试验性研究。该研究于2018年11月开始，将持续进行，直至招募到40名合适的参与者。年龄在20至49岁之间、被诊断为孤立性腰椎IVD突出且计划进行椎间盘切除术的患者为合适的候选者。所有提供知情同意的符合条件的参与者均接受标准的椎间盘切除术，随后植入UPAL凝胶。该试验的主要结果将是该手术的可行性和安全性。次要结果将包括自我评估的临床评分以及基于磁共振成像的IVD组织形态和成分质量的测量。初步结果将在24周时公布。将使用描述性统计分析可行性和安全性。将对治疗效果趋势进行意向性分析和符合方案分析。
