Clinical Effectiveness of Intervertebral Disc Release in Treating Lenke 5 Adolescent Idiopathic Scoliosis (INDIRECT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- The correction rate of axial rotation of the apex vertebrae
研究概览
简要总结
Adolescent idiopathic scoliosis (AIS) poses challenges in achieving optimal three-dimensional correction. While posterior fusion with pedicle screws has shown success, osteotomy techniques, such as Ponte osteotomy, have further improved outcomes. However, residual vertebral rotation remains a concern, impacting long-term complications. Intervertebral disc release (IDR) presents a potential solution to enhance derotation and reduce fusion levels, particularly in Lenke Type 5 AIS. This prospective randomized controlled trial aims to evaluate the clinical effectiveness of IDR in treating Lenke 5 AIS, comparing it to Ponte osteotomy. The study focuses on axial vertebral rotation correction, coronal curve improvement, blood loss, hospital stay, and adverse events. Participants aged 10-18 with Lenke 5 AIS will undergo either IDR or Ponte osteotomy, randomly assigned. Outcome measures include axial rotation correction rate, radiographic parameters, and clinical assessments. A total of 132 participants will be recruited. The IDR technique, through posterior disc removal, presents a promising approach to optimize derotation in Lenke 5 AIS. While offering potential advantages, challenges like limited working space and bleeding risks require careful consideration. The study's findings aim to provide robust clinical evidence, enhancing treatment strategies for Lenke 5 AIS and offering innovative approaches for AIS as a whole.
详细描述
Hypotheses To examine the clinical effectiveness of intervertebral disc release in treating Lenke 5 adolescent idiopathic scoliosis, our working hypothesis posits that participants treated with intervertebral disc release achieve a higher rate of correction for axial vertebral rotation (especially the rotation of the apex vertebrae), demonstrate improved correction rate for coronal curve, experience no additional blood loss or allogeneic transfusions, and do not experience an increase in the length of hospital stay (LOH) or adverse event (AE) rate compared to individuals treated with Ponte osteotomy.
Objectives Based on the aforementioned hypothesis, this study aims to evaluate the clinical effectiveness of intervertebral disc release in treating Lenke 5 adolescent idiopathic scoliosis. The evaluation includes assessing the efficacy of vertebral derotation and the change in Cobb angle following the correction surgery, as well as perioperative blood loss, transfusion volume/rate, length of hospital stay, and the rate of adverse events (AEs).
Study setting and investigators The trial will take place at a tertiary care teaching hospital. The study will be conducted in the wards and operating rooms of the orthopedic department, which has 200 beds, at this comprehensive hospital with a total of 2500 beds. Participants will be recruited from the outpatient clinic by one investigator and will provide their consent to the investigators. All investigators have practical experience in clinical orthopedic research projects. A single team of surgeons, who have completed a clinical fellowship in spinal surgery, will perform the surgeries.
Participants The study will enroll patients between the ages of 10 and 18, with an American Society of Anesthesiologists (ASA) physical status classification of I-II. These patients will be diagnosed with Lenke 5 type adolescent idiopathic scoliosis and will require posterior correction, internal fixation, and bone graft fusion. Enrollment in the study will be contingent upon signing a written informed consent.
Patients with a history of previous corrective surgery, or with sharp, angulated short-segmental scoliosis, and those with congenital scoliosis requiring 3-column osteotomy will be excluded. Participants who experience dura mater laceration or unexpected massive bleeding during the operation will be excluded as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 10 and 18
- •American Society of Anesthesiologists (ASA) physical statusclassification of I-II
- •Lenke 5 type adolescent idiopathic scoliosis
排除标准
- •A history of previous corrective surgery
- •With sharp, angulated short-segmental scoliosis
- •With congenital scoliosis requiring 3-column osteotomy
研究组 & 干预措施
IDR group
A group designated as the IDR group will undergo subsequent intervertebral disc release following Ponte osteotomy on the predetermined vertebral levels.
干预措施: intervertebral disc release (Procedure)
PO group
The PO group will solely undergo Ponte osteotomy.
干预措施: Ponte osteotomy (Procedure)
结局指标
主要结局
The correction rate of axial rotation of the apex vertebrae
时间窗: immediately before surgery and one week after the surgery
Axial rotation of apex vertebrae will be measured before and one week after the surgery using a novel computer-based automated measurement algorithm applied to computed tomography (CT) images. The algorithm used is a symmetry ratio algorithm that eliminates the need for manual landmark selection. It operates on the premise that the axis of maximum symmetry in a vertebral cross-section determines the angular orientation of the vertebra.
次要结局
- Visible blood loss(immediately after surgery)
- The incidence of nerve damage(through study completion, an average of 3 years)
- The lowest instrumented vertebra disc angle(immediately before surgery, 1-week post surgery, 3-month, 6-month, 1-year, 2-year, and 3-year follow-up)
- C7-CSVL(immediately before surgery, 1-week post surgery, 3-month, 6-month, 1-year, 2-year, and 3-year follow-up)
- Lumbar lordosis(immediately before surgery, 1-week post surgery, 3-month, 6-month, 1-year, 2-year, and 3-year follow-up)
- Scoliosis Research Society-22,SRS-22 score(immediately before surgery, 1-week post surgery, 3-month, 6-month, 1-year, 2-year, and 3-year follow-up)
- UIV tilt(immediately before surgery, 1-week post surgery, 3-month, 6-month, 1-year, 2-year, and 3-year follow-up)
- Radiographic parameters measured by CT scan: LIV and LIV+1 translation(immediately before surgery, 1-week post surgery, 3-month, 6-month, 1-year, 2-year, and 3-year follow-up)
- Age(immediately before surgery)
- Gender(immediately before surgery)
- Risser grade of the patients at the time of surgery(immediately before surgery)
- number of fused spinal levels(immediately after surgery)
- length of operation(immediately after surgery)
- Lumbar curve(immediately before surgery, 1-week post surgery, 3-month, 6-month, 1-year, 2-year, and 3-year follow-up)
- SVA(immediately before surgery, 1-week post surgery, 3-month, 6-month, 1-year, 2-year, and 3-year follow-up)
- LIV tilt(immediately before surgery, 1-week post surgery, 3-month, 6-month, 1-year, 2-year, and 3-year follow-up)
- Rate of postoperative infection(immediately after surgery)
- the MOS item short from health survey, SF-36 score(immediately before surgery, 1-week post surgery, 3-month, 6-month, 1-year, 2-year, and 3-year follow-up)
- EuroQol Five Dimensions Questionnaire, EQ-5D score(immediately before surgery, 1-week post surgery, 3-month, 6-month, 1-year, 2-year, and 3-year follow-up)
- Perioperative transfusion rates(immediately after surgery)
- Perioperative total blood loss(immediately after surgery)
- The incidence of loss of correction(through study completion, an average of 3 years)
- Perioperative transfusion amounts(immediately after surgery)