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

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.

Study Overview

• Status: Recruiting
• Conditions: Tibial Fractures; Distal Tibial Fracture
• Intervention / Treatment: Device: Robot-assisted closed reduction; Procedure: Traditional surgeon-led reduction

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chunpeng Zhao, MD / Chief Physician; Phone Number: +86 18610012704; Email: zcpllza2008@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100035
      • Recruiting
      • Beijing Jishuitan Hospital
      • Contact: Chunpeng Zhao, MD / Chief Physician; Phone Number: +86 18610012704; Email: zcpllza2008@163.com
    • Beijing, Beijing Municipality, China, 100035
      • Recruiting
      • Aerospace Center Hospital
      • Contact: Yonghui Liang, MD / Chief Physician

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robot-Assisted Group	Device: 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.
Active Comparator: Traditional Group	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Excellent or Good Closed Fracture Reduction Assessed by Postoperative Low-Dose CT-Based 3D Quantitative Reduction Grading Criteria	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: Separation/shortening displacement: Excellent (≤3mm), Good (>3-5mm), Fair (>5-10mm), Poor (>10mm).; Angulation deformity: Excellent (≤3°), Good (>3-5°), Fair (>5-10°), Poor (>10°).; 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Operation Time Measured in Minutes	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	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	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	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	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	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	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	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	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	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	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	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	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	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

Collaborators and Investigators

• Sponsor: Beijing Jishuitan Hospital
• Collaborators: Aerospace Center Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: June 29, 2026
• First Submitted That Met QC Criteria: July 28, 2026
• First Posted (Actual): July 29, 2026

Study Record Updates

• Last Update Posted (Actual): July 29, 2026
• Last Update Submitted That Met QC Criteria: July 28, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Tibial Fractures
• Other Study ID Numbers: Ji-Lun [K2026] No. [190]-00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No