Spine Center and Department of Orthopaedic Surgery, Seoul National University College of Medicine and Seoul National University Bundang Hospital, 82, Gumi-ro 173 Beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do 13620, Seongnam, Republic of Korea.
Department of Orthopedic Surgery, Spine Center, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.
J Orthop Surg Res. 2022 Aug 31;17(1):397. doi: 10.1186/s13018-022-03289-w.
Recombinant human bone morphogenetic protein-2 (rhBMP-2) has been widely used as an alternative bone graft in spine fusion surgery. However, clinical outcome such as effects and complications has not yet been revealed for transforaminal lumbar interbody fusion (TLIF). Although previous studies have reported some results, the evidence is weak. Therefore, the purpose of this trial is to evaluate the effectiveness and safety of Escherichia coli-derived rhBMP-2 combined with hydroxyapatite (HA) in TLIF.
This trial is designed as a prospective, assessor-blinded, open-label, multicenter, randomized controlled study. Participants will be recruited from six tertiary teaching hospitals. All randomized participants will be undergoing one- or two-level TLIF with rhBMP-2 (77 participants) as the active experimental group or with an auto-iliac bone graft (77 participants) as the control group. The primary interbody fusion rate outcome will be evaluated using computed tomography (CT) 12 months after surgery. The secondary outcomes will be as follows: clinical outcomes (visual analog scale score, EuroQol-5-dimensions-5-level score, Oswestry Disability Index score, and some surgery-related variables) and adverse effects (radiculitis, heterotrophic ossification, endplate resorption, and osteolysis). Radiological outcomes will be evaluated using simple radiography or CT. All outcomes will be measured, collected, and evaluated before surgery and at 12, 24, and 52 weeks postoperatively.
This study will be the primary of its kind to evaluate the effectiveness and safety of E. coli-derived rhBMP-2 with HA in one- or two-level TLIF. It is designed to evaluate the equivalence of the results between rhBMP-2 with HA and auto-iliac bone graft using an appropriate sample size, assessor-blinded analyses, and prospective registration to avoid bias. This study will set up clear conclusions for using E. coli-derived rhBMP-2 with HA in TLIF.
This study protocol was registered at Korea Clinical Research Information Service ( https://cris.nih.go.kr ; number identifier: KCT0005610) on 19 November 2020. And protocol version is v1.1, January 2022.
重组人骨形态发生蛋白-2（rhBMP-2）已被广泛用作脊柱融合手术中的替代骨移植物。然而，经椎间孔腰椎体间融合术（TLIF）的临床效果和并发症尚未得到证实。尽管先前的研究已经报道了一些结果，但证据不足。因此，本试验旨在评估大肠杆菌来源 rhBMP-2 联合羟基磷灰石（HA）在 TLIF 中的有效性和安全性。
本试验设计为前瞻性、评估者盲法、开放标签、多中心、随机对照研究。参与者将从六家三级教学医院招募。所有随机参与者将接受单节段或双节段 TLIF，rhBMP-2（77 名参与者）为活性实验组，自体髂骨移植物（77 名参与者）为对照组。术后 12 个月采用 CT 评估主要椎间融合率。次要结果包括：临床结果（视觉模拟评分、欧洲五维健康量表评分、Oswestry 残疾指数评分和一些手术相关变量）和不良反应（神经根炎、异位骨化、终板吸收和骨溶解）。影像学结果将采用简单的 X 线或 CT 进行评估。所有结果将在术前、术后 12、24 和 52 周进行测量、收集和评估。
本研究将是首例评估大肠杆菌来源 rhBMP-2 联合 HA 在单节段或双节段 TLIF 中的有效性和安全性的研究。本研究旨在通过合适的样本量、评估者盲法分析和前瞻性注册来评估 rhBMP-2 联合 HA 与自体髂骨移植物结果的等效性，以避免偏倚。本研究将为 rhBMP-2 联合 HA 在 TLIF 中的应用提供明确的结论。
本研究方案于 2020 年 11 月 19 日在韩国临床研究信息服务（ https://cris.nih.go.kr ；注册号：KCT0005610）注册。方案版本为 v1.1，2022 年 1 月。
