Distal Tibial Fracture, Tibial Fractures
Conditions
Brief summary
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.
Interventions
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.
PROCEDURETraditional 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.
Sponsors
Beijing Jishuitan Hospital
Aerospace Center Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Excellent or Good Closed Fracture Reduction Assessed by Postoperative Low-Dose CT-Based 3D Quantitative Reduction Grading Criteria | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Operation Time Measured in Minutes | 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. |
| Number of Intraoperative C-Arm Fluoroscopy Shots | 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. |
| Intraoperative Blood Loss Measured in Milliliters | 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. |
| Length of Hospital Stay Measured in Days | 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. |
| 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 | 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 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 | 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. |
| 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 | 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. |
| Foot and Ankle Ability Measure-Activities of Daily Living Score | 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. |
| Lower Extremity Functional Scale Score | 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. |
| EuroQol 5-Dimension 5-Level Health Index | 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. |
| EuroQol Visual Analogue Scale Score | 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. |
| Incidence of Intraoperative Complications | 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. |
| Incidence of Postoperative Complications | 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. |
| Incidence of Reoperation | 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. |
Countries
China
Contacts
CONTACTChunpeng Zhao, MD / Chief Physician
Outcome results
None listed