研究方案：脊柱导航（SPINAV）试验——脊柱畸形手术中椎弓根螺钉置入的增强现实手术导航、传统影像引导导航和徒手技术的比较
Study protocol: the SPInal NAVigation (SPINAV) trial - comparison of augmented reality surgical navigation, conventional image-guided navigation, and free-hand technique for pedicle screw placement in spinal deformity surgery.
作者信息
El-Hajj Victor Gabriel, Charalampidis Anastasios, Fell Daniel, Edström Erik, Elmi-Terander Adrian, Gerdhem Paul
机构信息
Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden.
出版信息
BMC Musculoskelet Disord. 2025 Jun 2;26(1):543. doi: 10.1186/s12891-025-08817-3.
BACKGROUND AND PURPOSE
Although navigation is increasingly used in spinal surgery, the advantage of different navigation technologies is still a matter of debate. Conventional image-guided navigation is currently the gold standard. However, modern, Augmented reality-based navigation methods are increasingly gaining ground. Surgical navigation in deformity surgery allows placement of pedicle screws in small and deformed pedicles and may result in both a higher accuracy and density of pedicle screw placement. The aim of this trial is to compare AR and conventional surgical navigation to free-hand technique.
PATIENTS AND METHODS
This is a single center, open label, parallel assignment, three arm, randomized, controlled trial, comparing: Augmented reality surgical navigation (ARSN), Infrared surgical navigation (IRSN) and Free-hand (FH) technique. Individuals scheduled for spinal deformity surgery are eligible for inclusion. The inclusion criteria are written informed consent, age ≥ 12 years and spinal deformity. Subjects will be randomized intraoperatively and strictly sequentially.
OUTCOMES
The primary endpoint is accurately placed pedicle screws based on intraoperative verification cone beam computed tomography (CBCT) scan. All radiological image analyses, on both intra- and postoperative imaging will be performed postoperatively by blinded reviewers. Several secondary outcome measures including revision rate, radiation exposure, implant density and final accuracy will be analyzed. Patient reported outcomes will also be assessed. Finally, a cost-benefit analysis will be performed.
START OF TRIAL AND ESTIMATED DURATION
The SPINAV trial started recruiting patients in January 2022 and will continue for approximately 2.5 years.
TRIAL REGISTRATION
The trial is registered at clinicaltrials.gov (NCT05107310) on 2021-11-03.
背景与目的
尽管导航技术在脊柱手术中的应用日益广泛，但不同导航技术的优势仍存在争议。传统的图像引导导航是目前的金标准。然而，基于增强现实的现代导航方法正越来越普及。畸形手术中的手术导航可将椎弓根螺钉置入小而畸形的椎弓根，可能会提高椎弓根螺钉置入的准确性和密度。本试验的目的是比较增强现实（AR）与传统手术导航及徒手技术。
患者与方法
这是一项单中心、开放标签、平行分组、三臂、随机对照试验，比较：增强现实手术导航（ARSN）、红外手术导航（IRSN）和徒手（FH）技术。计划进行脊柱畸形手术的个体符合纳入标准。纳入标准为书面知情同意、年龄≥12岁且患有脊柱畸形。受试者将在术中随机且严格按顺序分组。
结果
主要终点是基于术中验证锥形束计算机断层扫描（CBCT）扫描准确置入的椎弓根螺钉。所有术前和术后影像学的放射学图像分析将在术后由盲法评审员进行。将分析包括翻修率、辐射暴露、植入物密度和最终准确性在内的多个次要结局指标。还将评估患者报告的结局。最后，将进行成本效益分析。
试验开始时间和预计持续时间
SPINAV试验于2022年1月开始招募患者，并将持续约2.5年。
试验注册
该试验于2021年11月3日在clinicaltrials.gov（NCT05107310）注册。
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