Key Technology Research and Development for Intelligent Minimally Invasive Precision Treatment of Fractures (Sub-project 3: A Randomized Controlled Trial of Robot-Assisted Closed Reduction and Internal Fixation for Supracondylar Femoral Fractures)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Rate of Excellent or Good Closed Fracture Reduction Assessed by Postoperative Low-Dose CT-Based 3D Quantitative Reduction Grading Criteria
研究概览
简要总结
This study aims to evaluate the clinical efficacy and safety of an intelligent robotic system for the closed reduction of extra-articular supracondylar femoral fractures (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association AO/OTA 33-A). Traditional manual reduction for supracondylar femoral fractures is often challenging due to strong muscle pull, heavily relying on the surgeon's experience and frequently requiring repeated fluoroscopy. This clinical trial compares robot-assisted closed reduction against traditional surgeon-led reduction methods. The primary goal is to determine if the robotic system improves the precision of bone alignment (excellent and good reduction rate) and functional recovery while reducing surgical radiation exposure.
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)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years old
- •Unilateral, acute, closed extra-articular supracondylar femoral fracture (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association AO/OTA 33-A)
- •Time from injury to surgery ≤21 days
- •Able to walk independently before injury (assistive devices allowed)
排除标准
- •Open fractures or multiple severe traumas requiring priority treatment
- •Asymmetrical lower extremities, or prior malunion of the ipsilateral femur, or pre-existing deformities significantly affecting rotation/length evaluation
- •Unilateral fractures combined with other sites
- •Pathological fractures (tumor or metabolic)
- •Prior complex implants in place or previous surgeries significantly affecting evaluation
- •Active infection or severe systemic medical contraindications (unable to tolerate anesthesia/surgery)
- •Cognitive impairment, poor compliance, pregnancy, or lactation
- •Deemed unsuitable by the investigator (e.g., unable to follow up, or extreme obesity severely limiting the surgical or robotic workspace)
- •Refused randomization or enrollment
结局指标
主要结局
Rate of Excellent or Good Closed Fracture Reduction Assessed by Postoperative Low-Dose CT-Based 3D Quantitative Reduction Grading Criteria
时间窗: From completion of surgery to postoperative low-dose CT assessment, assessed up to 2 weeks after surgery
The percentage of patients achieving "Excellent" or "Good" anatomical closed reduction. Reduction quality is measured on post-op CT via RadiAnt DICOM Viewer and 3D Slicer based on the worst-performing of 3 dimensions: 1. Separation/shortening displacement: Excellent (≤3mm), Good (\>3-5mm), Fair (\>5-10mm), Poor (\>10mm). 2. Angulation deformity: Excellent (≤3°), Good (\>3-5°), Fair (\>5-10°), Poor (\>10°). 3. Rotational deformity: Excellent (≤3°), Good (\>3-5°), Fair (\>5-10°), Poor (\>10°). The final reduction grade is determined by the lowest category among these parameters, and the primary outcome represents the proportion of patients graded as Excellent or Good.
次要结局
- Total Operation Time Measured in Minutes(From initial skin incision to completion of skin closure, assessed up to 8 hours)
- Number of Intraoperative C-Arm Fluoroscopy Shots(From initial skin incision to completion of skin closure, assessed up to 8 hours)
- Intraoperative Blood Loss Measured in Milliliters(From initial skin incision to completion of skin closure, assessed up to 8 hours)
- Length of Hospital Stay Measured in Days(From hospital admission to hospital discharge, assessed up to 30 days)
- Robot-Assisted Reduction Planning and Execution Time Measured in Minutes in the Experimental Group(From initial skin incision to completion of the reduction maneuver, assessed up to 8 hours)
- Time to Radiographic Fracture Union Assessed by Standard X-Ray(From completion of surgery to the first documented radiographic evidence of fracture union, assessed up to 6 months after surgery)
- Radiographic Fracture Union Rate Assessed by Standard X-Ray(From completion of surgery to the first documented radiographic evidence of fracture union, assessed up to 6 months after surgery)
- American Knee Society Score(From baseline to 1 month, 3 months and 6 months after surgery)
- Lower Extremity Functional Scale(From baseline to 1 month, 3 months and 6 months after surgery)
- EuroQol 5-Dimension 5-Level Health-Related Quality of Life(From baseline to 1 month, 3 months and 6 months after surgery)
- EuroQol Visual Analogue Scale Score(From baseline to 1 month, 3 months and 6 months after surgery)
- Incidence of Intraoperative Complications(From initial skin incision to completion of skin closure, assessed up to 8 hours)
- Incidence of Postoperative Complications(From completion of surgery to postoperative complication assessment, assessed up to 6 months after surgery)
- Incidence of Reoperation(From completion of surgery to reoperation assessment, assessed up to 6 months after surgery)