Femoral Fractures, Supracondylar Femoral Fractures
Conditions
Keywords
Fracture Fixation, Robotic Surgical Procedures, Minimally Invasive Surgical Procedures, Anatomic Reduction Standard, Artificial Intelligence
Brief summary
This study aims to evaluate the clinical efficacy and safety of an intelligent robotic system for the closed reduction of extra-articular supracondylar femoral fractures (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association AO/OTA 33-A). Traditional manual reduction for supracondylar femoral fractures is often challenging due to strong muscle pull, heavily relying on the surgeon's experience and frequently requiring repeated fluoroscopy. This clinical trial compares robot-assisted closed reduction against traditional surgeon-led reduction methods. The primary goal is to determine if the robotic system improves the precision of bone alignment (excellent and good reduction rate) and functional recovery while reducing surgical radiation exposure.
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, internal fixation is performed using a distal femoral locking compression plate (LCP-DF) via the minimally invasive percutaneous plate osteosynthesis (MIPO) technique.
DEVICEConventional fracture reduction and internal fixation
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 femoral locking plates or intramedullary nails (with dual-plate fixation permitted when indicated for medial bone defects or collapse) 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
* Age between 18 and 80 years old * Unilateral, acute, closed extra-articular supracondylar femoral fracture (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association AO/OTA 33-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 femur, or pre-existing deformities significantly affecting rotation/length evaluation * Unilateral fractures combined with other sites * Pathological fractures (tumor or 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 * Deemed unsuitable by the investigator (e.g., unable to follow up, or extreme obesity severely limiting the surgical or robotic workspace) * Refused randomization or 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 6 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 6 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. |
| American Knee Society Score | From baseline to 1 month, 3 months and 6 months after surgery | The American Knee Society Score (AKSS) is used to evaluate the clinical outcomes and functional status of the knee joint post-operation. The total score ranges from 0 to 100, with a higher score indicating better knee function and a superior clinical outcome. |
| Lower Extremity Functional Scale | From baseline to 1 month, 3 months and 6 months after surgery | The Lower Extremity Functional Scale (LEFS) is used to evaluate the patient's ability to perform everyday tasks and lower extremity function. The score ranges from 0 to 80, with higher scores representing better functional status. |
| EuroQol 5-Dimension 5-Level Health-Related Quality of Life | From baseline to 1 month, 3 months and 6 months after surgery | The EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire is used to assess health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level scale, and health states are converted into an index score ranging from less than 0 to 1, where higher scores mean a better quality of life. |
| EuroQol Visual Analogue Scale Score | From baseline to 1 month, 3 months and 6 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 6 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 6 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