Key Technology Research and Development for Intelligent Minimally Invasive Precision Treatment of Fractures (Sub-project 4: A Randomized Controlled Trial of Robot-Assisted Closed Reduction and Internal Fixation for Distal Tibial Fractures)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 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 fracture reduction robot system in treating extra-articular distal tibial fractures. Traditional manual bone setting depends heavily on a surgeon's experience, which can sometimes lead to inconsistent alignment and increased radiation exposure. This clinical trial compares robot-assisted closed reduction against the traditional surgeon-led method. The primary goal is to determine if the robotic system improves the rate of accurate fracture alignment (excellent and good reduction rate) and helps patients recover better.
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
- •Unilateral, acute, closed distal tibial fractures (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association AO/OTA 43-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 tibia, or pre-existing deformities significantly affecting rotation/length evaluation
- •Ipsilateral fractures combined with other sites
- •Pathological fractures (tumor/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
- •Poor local skin conditions (e.g., obvious blisters, severe soft tissue injury)
- •Deemed unsuitable by the investigator (e.g., unable to follow up as planned) or refused randomization/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 12 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 12 months after surgery)
- Incidence of Intraoperative Complications(From initial skin incision to completion of skin closure, assessed up to 8 hours)
- Foot and Ankle Ability Measure-Activities of Daily Living Score(From baseline to 1 month, 3 months, 6 months and 12 months after surgery)
- Lower Extremity Functional Scale Score(From baseline to 1 month, 3 months, 6 months and 12 months after surgery)
- EuroQol 5-Dimension 5-Level Health Index(From baseline to 1 month, 3 months, 6 months and 12 months after surgery)
- EuroQol Visual Analogue Scale Score(From baseline to 1 month, 3 months, 6 months and 12 months after surgery)
- Incidence of Postoperative Complications(From completion of surgery to postoperative complication assessment, assessed up to 12 months after surgery)
- Incidence of Reoperation(From completion of surgery to reoperation assessment, assessed up to 12 months after surgery)