An interventional study of Robot-assisted closed reduction and Traditional surgeon-led reduction in Distal Tibial Fracture and Tibial Fractures, sponsored by Beijing Jishuitan Hospital. Recruiting at 2 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Beijing Jishuitan Hospital · Not applicable, Interventional, and Treatment
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.
135 studies on the registry are indexed under Tibial Fractures; 37 are open to participants now.
This study's planned enrollment of 60 is close to the median of 65 across 91 interventional studies indexed under Tibial Fractures.
Browse Tibial Fractures studies →Beijing Jishuitan Hospital is the lead sponsor of 44 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Robot-assisted closed reduction
Procedure: Traditional surgeon-led 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.
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.
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: 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.
Time frame: From completion of surgery to postoperative low-dose CT assessment, assessed up to 2 weeks after surgery
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From completion of surgery to reoperation assessment, assessed up to 12 months after surgery
Plan to share: No
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Started Jul 2026 (actual). Primary completion is estimated for Dec 2027, 17 months after the start.
Of 39 interventional studies with no phase under Tibial Fractures, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 80. This study's planned 17 months is below that.
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Beijing Jishuitan Hospital