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Robot-Assisted Closed Reduction and Internal Fixation for Extra-Articular Distal Tibial Fractures

2026年7月28日 更新者：Beijing Jishuitan Hospital

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)

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Chunpeng Zhao, MD / Chief Physician
  • 电话号码：+86 18610012704
  • 邮箱：zcpllza2008@163.com

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100035
        • 招聘中
        • Beijing Jishuitan Hospital
        • 接触：
          • Chunpeng Zhao, MD / Chief Physician
          • 电话号码：+86 18610012704
          • 邮箱：zcpllza2008@163.com
      • Beijing、Beijing Municipality、中国、100035
        • 招聘中
        • Aerospace Center Hospital
        • 接触：
          • Yonghui Liang, MD / Chief Physician

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Robot-Assisted Group
设备：Robot-assisted closed reduction
The patient undergoes automated or human-robot collaborative closed fracture reduction powered by an intelligent robotic system. The system integrates deep-learning-based bone segmentation, automatic reduction planning, and a self-adaptive 2D-3D image registration framework to achieve sub-millimeter positioning feedback and force-position collaborative security gates. Following successful reduction, the fracture is fixed with a distal tibial locking plate via the minimally invasive percutaneous plate osteosynthesis (MIPO) technique.
有源比较器：Traditional Group
程序：Traditional surgeon-led reduction
The patient undergoes conventional closed or open fracture reduction performed entirely by the surgical team based on traditional clinical experience under ordinary C-arm fluoroscopic guidance. Internal fixation is achieved using standard distal tibial locking plates or intramedullary nails according to the surgeon's choice and standard of care.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Rate of Excellent or Good Closed Fracture Reduction Assessed by Postoperative Low-Dose CT-Based 3D Quantitative Reduction Grading Criteria
大体时间：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.
From completion of surgery to postoperative low-dose CT assessment, assessed up to 2 weeks after surgery

次要结果测量

结果测量
措施说明
大体时间
Total Operation Time Measured in Minutes
大体时间：From initial skin incision to completion of skin closure, assessed up to 8 hours
Total operation time will be measured in minutes and defined as the duration from initial skin incision to completion of skin closure.
From initial skin incision to completion of skin closure, assessed up to 8 hours
Number of Intraoperative C-Arm Fluoroscopy Shots
大体时间：From initial skin incision to completion of skin closure, assessed up to 8 hours
The number of intraoperative fluoroscopy shots taken using the C-arm during the surgical procedure will be recorded.
From initial skin incision to completion of skin closure, assessed up to 8 hours
Intraoperative Blood Loss Measured in Milliliters
大体时间：From initial skin incision to completion of skin closure, assessed up to 8 hours
The estimated total volume of blood loss during the surgical procedure will be recorded in milliliters.
From initial skin incision to completion of skin closure, assessed up to 8 hours
Length of Hospital Stay Measured in Days
大体时间：From hospital admission to hospital discharge, assessed up to 30 days
The length of hospital stay will be recorded in days from admission to hospital discharge.
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
大体时间：From initial skin incision to completion of the reduction maneuver, assessed up to 8 hours
For participants assigned to the experimental group, the robot-assisted reduction planning and execution time will be recorded in minutes. This time is defined as the duration from completion of robotic arm setup to completion of the reduction maneuver.
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
大体时间：From completion of surgery to the first documented radiographic evidence of fracture union, assessed up to 12 months after surgery
Time to radiographic fracture union will be measured in weeks using standard anteroposterior and lateral X-rays. Fracture union is defined as cortical bridging in at least 3 of 4 cortices with no significant pain during weight-bearing. Low-dose CT may be used to confirm fracture union in uncertain cases.
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
大体时间：From completion of surgery to the first documented radiographic evidence of fracture union, assessed up to 12 months after surgery
The percentage of participants achieving radiographic fracture union will be assessed using standard anteroposterior and lateral X-rays. Low-dose CT may be used to confirm fracture union in uncertain cases.
From completion of surgery to the first documented radiographic evidence of fracture union, assessed up to 12 months after surgery
Foot and Ankle Ability Measure-Activities of Daily Living Score
大体时间：From baseline to 1 month, 3 months, 6 months and 12 months after surgery
The Foot and Ankle Ability Measure-Activities of Daily Living (FAAM-ADL) score is used to assess the functional status of patients with foot and ankle disorders. The subscale consists of 21 items, with a maximum total raw score of 84. The scores are converted into a percentage score ranging from 0% to 100%, where a higher score indicates a higher level of functional ability.
From baseline to 1 month, 3 months, 6 months and 12 months after surgery
Lower Extremity Functional Scale Score
大体时间：From baseline to 1 month, 3 months, 6 months and 12 months after surgery
The Lower Extremity Functional Scale (LEFS) is used to evaluate the patient's lower extremity function and ability to perform everyday tasks. The scale contains 20 items with a total raw score ranging from 0 to 80, where a higher score represents better functional status.
From baseline to 1 month, 3 months, 6 months and 12 months after surgery
EuroQol 5-Dimension 5-Level Health Index
大体时间：From baseline to 1 month, 3 months, 6 months and 12 months after surgery
The EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire evaluates health-related quality of life across 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The raw response is converted into a health state index score typically ranging from 0 (representing death) to 1 (representing perfect health), with higher scores reflecting better overall quality of life.
From baseline to 1 month, 3 months, 6 months and 12 months after surgery
EuroQol Visual Analogue Scale Score
大体时间：From baseline to 1 month, 3 months, 6 months and 12 months after surgery
The EuroQol Visual Analogue Scale (EQ VAS) provides a quantitative measure of the patient's self-rated overall health status. The score is recorded on a visual scale ranging from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
From baseline to 1 month, 3 months, 6 months and 12 months after surgery
Incidence of Intraoperative Complications
大体时间：From initial skin incision to completion of skin closure, assessed up to 8 hours
The percentage of participants experiencing intraoperative complications, including neurovascular injury, cortical perforation, abnormal bleeding, device failure, registration failure requiring manual takeover or change of reduction strategy, will be recorded.
From initial skin incision to completion of skin closure, assessed up to 8 hours
Incidence of Postoperative Complications
大体时间：From completion of surgery to postoperative complication assessment, assessed up to 12 months after surgery
The percentage of participants experiencing postoperative complications, including wound problems or infection, thrombotic events, internal fixation failure, or loss of reduction, will be recorded.
From completion of surgery to postoperative complication assessment, assessed up to 12 months after surgery
Incidence of Reoperation
大体时间：From completion of surgery to reoperation assessment, assessed up to 12 months after surgery
The percentage of participants requiring reoperation after the index surgery will be recorded.
From completion of surgery to reoperation assessment, assessed up to 12 months after surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Beijing Jishuitan Hospital

合作者

Aerospace Center Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月1日

初级完成 (估计的)

2027年12月31日

研究完成 (估计的)

2028年12月31日

研究注册日期

首次提交

2026年6月29日

首先提交符合 QC 标准的

2026年7月28日

首次发布 (实际的)

2026年7月29日

研究记录更新

最后更新发布 (实际的)

2026年7月29日

上次提交的符合 QC 标准的更新

2026年7月28日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • Ji-Lun [K2026] No. [190]-00

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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