Randomized Controlled Clinical Trial of Internal Fixation of Intertrochanteric Fractures of Femur Guided by Conventional Versus IF-AI Artificial Intelligence Program
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 132
- 主要终点
- Fracture healing situation 36 weeks after surgery
研究概览
简要总结
Our team has developed an AI software to guide the surgical protocol for femoral intertrochanteric fractures. This is a prospective randomized controlled clinical study that will include patients with femoral intertrochanteric fractures combining medial posterior and lateral wall fractures, and will randomly divide the patients into a traditional surgical protocol group and an AI-guided surgical protocol group. The efficacy and safety indexes such as operation time, blood loss, operation cost, infection rate, hospitalization time, postoperative pain score, fracture healing time, internal fixation failure rate and mortality rate were compared between the two groups to verify the efficacy and safety of AI-guided surgical treatment plan.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 60 years old, male or female.
- •Osteoporosis intertrochanteric fracture, which met the diagnostic criteria of X-ray intertrochanteric fracture, and osteoporosis T-value <2.
- •Patients with 1mm resolution CT imaging data.
- •Willing to participate in the project, sign the informed consent, and be able to complete the follow-up work.
排除标准
- •Patients with pathological fractures, old fractures, stress fractures, and periprosthesis fractures;
- •Patients lacking 1mm resolution CT imaging data;
- •Severe malnutrition, heavy smoking, alcoholism and other systemic conditions affect fracture healing;
- •Patients with severe medical diseases that cannot be operated on;
- •Patients participating in other clinical studies.
结局指标
主要结局
Fracture healing situation 36 weeks after surgery
时间窗: 36 weeks after surgery
The results of surgical treatment of the patient were shown by imaging data at 36 weeks after surgery, and the treatment was considered successful without failure of internal fixation.
次要结局
未报告次要终点