Robot-Assisted Versus Traditional Closed Reduction and Internal Fixation for Femoral Shaft Fractures: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 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
The goal of this clinical trial is to evaluate the safety and efficacy of robot-assisted closed reduction for patients with femoral shaft fractures. The main questions it aims to answer are:
Does robot-assisted closed reduction provide a statistically significant improvement in the excellent and good reduction rates compared to conventional surgeon-performed reduction? How do the two reduction methods compare in terms of surgical efficiency, fracture healing, and patient functional outcomes? Researchers will compare the robot-assisted closed reduction group to the conventional surgeon-performed reduction group to see if robot-assisted surgery improves the precision of fracture reduction, stability of alignment, and post-operative functional recovery while minimizing trauma.
Participants will:
Undergo standardized screening to ensure they meet the inclusion criteria for acute, unilateral, closed femoral shaft fractures (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association [AO/OTA] classification 32).
Be randomized in a 1:1 ratio to receive either robot-assisted closed reduction or traditional surgeon-performed closed reduction, both followed by internal fixation.
Complete standardized perioperative management and follow-up assessments at 1, 3, 6, and 12 months post-surgery, including functional scales such as the Lower Extremity Functional Scale (LEFS) and the EuroQol Five-Dimensional Five-Level questionnaire (EQ-5D-5L), as well as radiographic imaging to monitor bone healing and potential complications.
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 18 to 80 years, inclusive.
- •Unilateral, acute, closed femoral shaft fracture.
- •AO/OTA classification 32-A, 32-B, or 32-C femoral shaft fracture.
- •Time from injury to surgery no more than 21 days.
- •Ability to walk independently before injury, with or without assistive devices.
- •Ability to provide written informed consent.
排除标准
- •Open fracture.
- •Multiple severe trauma requiring immediate priority management.
- •Asymmetry of the lower limbs.
- •History of ipsilateral femoral shaft malunion.
- •History of ipsilateral femoral deformity that significantly affects assessment of - limb rotation or length.
- •Ipsilateral fracture at another site.
- •Pathological fracture caused by tumor, metabolic bone disease, or other underlying bone pathology.
- •Complex hardware from previous ipsilateral surgery.
- •History of ipsilateral surgery that significantly affects clinical or radiographic evaluation.
- •Active infection.
- •Severe underlying medical condition that makes the patient unable to tolerate surgery.
- •Cognitive impairment that prevents study participation or follow-up.
- •Poor compliance with study procedures or follow-up.
- •Pregnancy or lactation.
- •Judged by the investigators to be unsuitable for enrollment.
- •Unable to complete the planned follow-up period.
- •Refusal to undergo randomization.
- •Refusal to participate in the clinical study.
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
Closed fracture reduction will be assessed on postoperative CT using a 3D quantitative grading system. Three dimensions will be graded as Excellent, Good, Fair, or Poor: displacement, angular deformity, and rotational deformity. The thresholds are \<=3 mm/degree for Excellent, \>3-5 mm/degree for Good, \>5-10 mm/degree for Fair, and \>10 mm/degree for Poor. The final grade will be the lowest grade across the three dimensions, and the excellent/good rate is the percentage of participants with a final grade of 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)
- Intraoperative Blood Loss Measured in Milliliters(From initial skin incision to completion of skin closure, assessed up to 8 hours)
- Change from Baseline in Lower Extremity Functional Scale Score (LEFS)(From baseline to 1 month, 3 months, 6 months, and 12 months after surgery)
- Change from Baseline in EuroQol 5-Dimension 5-Level Score( EQ-5D-5L)(From baseline to 1 month, 3 months, 6 months, and 12 months after surgery)
- Number of Intraoperative C-Arm Fluoroscopy Shots(From initial skin incision to completion of skin closure, assessed up to 8 hours)
- 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)
- Incidence of Reoperation(From completion of surgery to reoperation assessment, assessed up to 12 months after surgery)
- Length of Hospital Stay Measured in Days(From hospital admission to hospital discharge, assessed up to 30 days)
- 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)
- Incidence of Postoperative Complications(From completion of surgery to postoperative complication assessment, assessed up to 12 months after surgery)