A Prospective Randomized Controlled Trial of the Drum Tower Rule Machine Learning Model for Lowest Instrumented Vertebra Selection in Lenke Type 1 and Type 5 Adolescent Idiopathic Scoliosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Incidence of Distal Adding-on
研究概览
简要总结
This study will evaluate whether a machine learning-based decision support model, called the Drum Tower Rule, can help surgeons select the lowest instrumented vertebra during corrective surgery for adolescent idiopathic scoliosis.
Patients with Lenke type 1 or Lenke type 5 adolescent idiopathic scoliosis who are scheduled for posterior spinal fusion will be randomly assigned to one of two groups. In the model-guided group, surgeons will receive the model-predicted risk of postoperative distal adding-on and a recommendation for lowest instrumented vertebra selection. In the conventional-experience group, surgeons will select the lowest instrumented vertebra according to routine clinical experience and existing surgical principles, without access to the model output.
All patients will receive standard posterior spinal fusion. The main outcome is the incidence of distal adding-on at 24 months after surgery, assessed by blinded radiographic reviewers.
详细描述
Adolescent idiopathic scoliosis is a common spinal deformity in children and adolescents. For patients requiring corrective surgery, selection of the lowest instrumented vertebra is a key surgical decision. An inappropriate distal fusion level may increase the risk of postoperative distal adding-on, coronal imbalance, unnecessary loss of spinal mobility, or revision surgery.
The Drum Tower Rule is a machine learning-based decision support model developed to estimate the risk of postoperative distal adding-on and assist with lowest instrumented vertebra selection in patients with Lenke type 1 and Lenke type 5 adolescent idiopathic scoliosis. Before the start of this trial, the model, input variables, risk threshold, and software version will be locked and will not be modified during the study.
This is a single-center, prospective, randomized, open-label, parallel-group controlled trial with blinded outcome assessment. Eligible participants will be randomly assigned in a 1:1 ratio to either the model-guided group or the conventional-experience group. Randomization will be stratified by Lenke classification.
In the model-guided group, preoperative clinical and radiographic variables will be entered into the locked machine learning model. The model will generate a predicted risk of distal adding-on and a recommendation for lowest instrumented vertebra selection. For Lenke type 1 patients, the decision will focus on selection between one level proximal to the last substantially touching vertebra and the last substantially touching vertebra. For Lenke type 5 patients, the decision will focus on selection between L3 and L4. The surgeon will make the final decision after considering the model output and clinical judgment.
In the conventional-experience group, the surgeon will select the lowest instrumented vertebra based on routine clinical experience and existing surgical principles. The model output will not be provided to the surgeon for participants in this group.
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
- Single (Outcomes Assessor)
盲法说明
Surgeons cannot be masked because the model output is provided only in the model-guided group. Participants will not be actively informed of the assigned decision-support strategy, but participant masking is not considered the primary masking method. Radiographic outcome assessors who determine distal adding-on and other imaging outcomes will be blinded to treatment allocation.
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
- •Diagnosis of adolescent idiopathic scoliosis classified as Lenke type 1A or Lenke type 5C.
- •Age 10 to 18 years, inclusive.
- •Scheduled to undergo posterior spinal fusion using an all-pedicle screw instrumentation system.
- •Planned selective thoracic fusion or selective lumbar fusion, with a clinical need for lowest instrumented vertebra decision-making.
- •Availability of required preoperative standing full-spine radiographs and bending radiographs.
- •Ability and willingness to complete the planned 24-month postoperative follow-up.
- •Written informed consent provided by the participant and legal guardian.
排除标准
- •- Congenital scoliosis, neuromuscular scoliosis, syndromic scoliosis, or other non-idiopathic scoliosis.
- •History of spinal trauma, spinal tumor, spinal tuberculosis, or spinal infection.
- •Previous spinal surgery.
- •Severe sagittal spinal deformity, such as Scheuermann disease, for which the study model is not applicable.
- •Neurological symptoms or signs.
- •Leg length discrepancy greater than 10 mm.
- •The surgeon determines that there is no clinical equipoise for lowest instrumented vertebra selection because one option is clearly contraindicated for safety or anatomical reasons.
- •Inability to complete follow-up or required study assessments.
结局指标
主要结局
Incidence of Distal Adding-on
时间窗: 24 months after surgery
Distal adding-on is defined as an increase of more than 5 degrees in the disc angle below the lowest instrumented vertebra compared with the immediate postoperative radiograph, or an increase of more than 5 mm in the translation of the vertebra below the lowest instrumented vertebra relative to the central sacral vertical line. The outcome will be assessed by blinded radiographic reviewers.
次要结局
- Scoliosis Research Society-22 Score(24 months after surgery)