Post Anne Mareille, Berends Hanneke I, van Royen Barend J
Department of Orthopedic Surgery and Sports Medicine, University Medical Center Amsterdam, Amsterdam, Netherlands.
Amsterdam Movement Sciences, Amsterdam, Netherlands.
JMIR Res Protoc. 2023 Dec 25;12:e47222. doi: 10.2196/47222.
The current surgical treatment for patients diagnosed with progressive and severe adolescent idiopathic scoliosis (AIS) consists of the correction of the spinal curvature, followed by posterior spinal fusion (PSF). However, research has uncovered short- and long-term complications of posterior spinal fusion in patients with AIS. Minimally invasive growing rod techniques have successfully been used to treat patients with early-onset scoliosis and neuromuscular scoliosis. It may be questioned if minimally invasive posterior spinal nonfusion (PSnF) surgery with bipolar instrumentation can be used for the treatment of AIS.
This study will be performed to monitor the efficacy and safety of PSnF surgery by using a commercially available Conformité Européenne-certified spinal implant consisting of bilateral bipolar one-way self-expanding rods (OWSER) for the treatment of patients diagnosed with AIS.
In 14 selected patients with AIS with Lenke 1-6 curves, minimally invasive PSnF surgery with the OWSER system is performed after the failure of conservative treatment (curve progression of >5° within 1 year). The patients are over 7 years of age, with a major Cobb angle of ≥30°, sufficient flexibility, and a Risser stage of ≤2. Patients will be followed over time, according to the standard medical care. Efficacy will be measured using radiological and patient satisfaction assessments and safety will be determined by the amount of perioperative complications.
Patient inclusion started on November 17, 2021 and we hope to finalize patient inclusion by the beginning of 2025. The first results will be expected by the beginning of 2024.
Minimally invasive PSnF in patients with AIS is presented as a less invasive surgical technique that prevents the progression of the scoliotic curve and that allows minor posture correction of coronal imbalance. This will be the first study to examine whether the PSnF bipolar OWSER instrumentation will be the next generation of surgical instrumentation in AIS.
ClinicalTrials.gov NCT04441411; https://clinicaltrials.gov/study/NCT04441411.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47222.
目前，对于诊断为进行性重度青少年特发性脊柱侧凸（AIS）患者的手术治疗包括脊柱侧弯矫正，随后进行后路脊柱融合术（PSF）。然而，研究发现了AIS患者后路脊柱融合术的短期和长期并发症。微创生长棒技术已成功用于治疗早发性脊柱侧凸和神经肌肉型脊柱侧凸患者。使用双极器械的微创后路脊柱非融合（PSnF）手术是否可用于治疗AIS可能会受到质疑。
本研究将通过使用一种经欧洲合格认证的市售脊柱植入物（由双侧双极单向自膨胀棒（OWSER）组成）来监测PSnF手术治疗诊断为AIS患者的疗效和安全性。
在14例选定的Lenke 1-6型曲线的AIS患者中，在保守治疗失败（1年内曲线进展>5°）后，使用OWSER系统进行微创PSnF手术。患者年龄超过7岁，主 Cobb角≥30°，有足够的柔韧性，Risser分期≤2。将根据标准医疗护理对患者进行长期随访。疗效将通过影像学和患者满意度评估来衡量，安全性将通过围手术期并发症的数量来确定。
患者纳入于2021年11月17日开始，我们希望在2025年初完成患者纳入。预计2024年初得出首批结果。
AIS患者的微创PSnF是一种侵入性较小的手术技术，可防止脊柱侧凸曲线进展，并可对冠状面失衡进行轻微的姿势矫正。这将是第一项研究PSnF双极OWSER器械是否会成为AIS手术器械的下一代产品的研究。
ClinicalTrials.gov NCT04441411；https://clinicaltrials.gov/study/NCT04441411。
国际注册报告识别码（IRRID）：DERR1-10.2196/47222。
