Spine Surgery, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy
Applied and Translational Research Center, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.
BMJ Open. 2024 Jul 16;14(7):e075802. doi: 10.1136/bmjopen-2023-075802.
Minimally invasive spine surgery (MISS) has been shown to be safe and effective in adolescent idiopathic scoliosis (AIS) correction, even though there is no consensus on which treatment provides the best results.
The present study will be a randomised controlled trial with allocation 1:1. We will enrol 126 patients with Cobb≤70° undergoing AIS surgery. Patients will be divided into two groups, according to a randomisation list unknown to the surgeons. Group 1 will be treated with posterior spine fusion and group 2 with MISS. MISS technique: two midline noncontiguous skin incisions of 3 cm in length, 3-4 segments (6-8 pedicles screws) instrumented per skin incision, uniplanar and polyaxial pedicle screws inserted bilaterally on each side of the proximal and distal levels, rod translation manoeuvre and C-D manoeuvre performed on the distal part. Clinical and radiological follow-ups will be performed for 5 years. Values of Cobb angles degrees will be collected to study the correction rate of the structural major curve. Postoperative and preoperative anterior-posterior (AP) direct radiography will be compared with the last follow-up examination. Operative time, preoperative haemoglobin (Hb) and second postoperative day Hb, full length of hospitalisation, time to achieve verticalisation and time to remove the drainage will be recorded. Numeric Rating Scale (NRS) medium score will be assessed immediately after surgery and during the whole postoperative rehabilitation treatment to estimate pain reduction. Complications will be collected postoperatively and throughout the whole follow-up period.Moreover, questionnaires will be administered at follow-up (NRS, Scoliosis Research Society-22 and Oswestry Disability Index) for the clinical assessment.
The study protocol has been approved by the local ethic committee Area Vasta Emilia Romagna Centro. Written informed consent will be collected for all the participants. Findings of this study will be disseminated through peer-reviewed publications and conference presentations.
NCT05860673.
微创脊柱手术（MISS）已被证明在青少年特发性脊柱侧凸（AIS）矫正中是安全有效的，尽管对于哪种治疗方法能提供最佳结果尚无共识。
本研究将是一项随机对照试验，分配比例为 1:1。我们将招募 126 名 Cobb 角≤70°的 AIS 手术患者。根据外科医生未知的随机分组表，患者将分为两组。第 1 组将接受后路脊柱融合术，第 2 组将接受 MISS 治疗。MISS 技术：两条中线非连续的 3cm 长皮肤切口，每个皮肤切口置入 3-4 个节段（6-8 个椎弓根螺钉），双侧在近端和远端水平的每一侧置入单平面和多轴椎弓根螺钉，在远端部分进行棒平移操作和 C-D 操作。将进行 5 年的临床和影像学随访。收集 Cobb 角度数值以研究结构性主曲线的矫正率。将比较术后和术前前后位（AP）直接 X 线片与最后一次随访检查。记录手术时间、术前血红蛋白（Hb）和术后第 2 天 Hb、总住院时间、达到直立的时间和拔除引流管的时间。术后即刻和整个术后康复治疗期间将评估数字评分量表（NRS）的中值评分，以评估疼痛减轻情况。术后和整个随访期间将收集并发症。此外，将在随访时（NRS、脊柱侧凸研究协会-22 问卷和 Oswestry 残疾指数）进行问卷调查以进行临床评估。
该研究方案已获得艾米利亚-罗马涅大区中心区域伦理委员会的批准。将向所有参与者收集书面知情同意书。本研究的结果将通过同行评议的出版物和会议报告进行传播。
NCT05860673。
