Paediatric Orthopaedics Surgery Department, Necker Hospital, Université de Paris, Assistance Publique Hôpitaux de Paris, 149, Rue de Sevres, 75015, Paris, France.
Clinical Research Unit, Necker Hospital, Université de Paris, Assistance Publique Hôpitaux de Paris, 149, Rue de Sevres, Paris, 75015, France.
Eur Spine J. 2021 Mar;30(3):749-758. doi: 10.1007/s00586-021-06732-4. Epub 2021 Jan 24.
Progressive early-onset scoliosis raises major challenges for surgeons, as growth must be preserved. With traditional growing rods, the need for repeated surgery is associated with numerous complications, high costs, and heavy psychosocial burden on the patient and family. We assessed the safety and efficacy of a new one-way self-expanding rod (OWSER).
This prospective single-centre phase 2 study included two groups of children with progressive EOS treated by the OWSER in 2016-2017: Ten received a unilateral construct to treat progressive non-neuromuscular curves and 10 others a bilateral construct for neuromuscular scoliosis. Clinical and radiological data were assessed at surgery and 3, 6, 12, 18 months later. The primary endpoint was success defined as the absence of repeated surgery at 12 months.
In the non-neuromuscular group, rod expansion occurred in 5 of 10 patients [95% CI 19-81]; in the five other patients, rotational conflict inside the domino prevented rod expansion, four of them required surgery within the first 12 months. Rod expansion occurred spontaneously and during monthly traction sessions in all 10 neuromuscular patients [95% CI 69-100], without mechanical or device-related complications. Residual pelvic obliquity was improved by -3° [- 6.0 to 9.5] at 18 months. Lung function improved in the non-neuromuscular group.
In neuromuscular diseases, the OWSER bilateral construct seems to be safe and less aggressive. Used as unilateral construct in non-neuromuscular group, it was less effective. Accordingly, we recommend the bilateral construct for all aetiologies. That device could avoid further surgery and reduce the rate of complications after long follow-up.
进展性早发性脊柱侧凸对外科医生提出了重大挑战，因为必须保留生长。传统的生长棒需要反复手术，这与许多并发症、高成本以及患者和家庭的沉重心理社会负担有关。我们评估了一种新型单向自扩张棒（OWSER）的安全性和有效性。
这项前瞻性单中心 2 期研究纳入了 2016-2017 年接受 OWSER 治疗的进展性 EOS 患儿两组：10 例接受单侧结构治疗进展性非神经肌肉性曲线，10 例接受双侧结构治疗神经肌肉性脊柱侧凸。在手术时和术后 3、6、12、18 个月评估临床和影像学数据。主要终点为 12 个月时无重复手术定义的成功。
在非神经肌肉组，10 例患者中有 5 例发生棒扩张[95%CI 19-81]；在另外 5 例患者中，棒扩张被 Domino 内的旋转冲突所阻止，其中 4 例在最初 12 个月内需要手术。10 例神经肌肉患者的所有患者中，棒扩张均自发发生并在每月牵引过程中发生[95%CI 69-100]，无机械或器械相关并发症。18 个月时，残余骨盆倾斜度改善了-3°[-6.0 至 9.5]。非神经肌肉组的肺功能改善。
在神经肌肉疾病中，OWSER 双侧结构似乎是安全且侵袭性较小的。在非神经肌肉组中作为单侧结构使用时，效果较差。因此，我们建议对所有病因均使用双侧结构。该器械可避免进一步手术，并在长期随访后降低并发症发生率。
