Robot-Assisted Closed Reduction and Internal Fixation for Distal Femoral Fractures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Robot-assisted closed reduction, Conventional fracture reduction and internal fixation.
- Who it may be relevant to
- Registry conditions: Supracondylar Femoral Fractures, Femoral Fractures. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Key Technology Research and Development for Intelligent Minimally Invasive Precision Treatment of Fractures (Sub-project 3: A Randomized Controlled Trial of Robot-Assisted Closed Reduction and Internal Fixation for Supracondylar Femoral Fractures)
Overview
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
- 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, internal fixation is performed using a distal femoral locking compression plate (LCP-DF) via the - Device Conventional 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.
Primary outcome measures
- Rate of Excellent or Good Closed Fracture Reduction Assessed by Postoperative Low-Dose CT-Based 3D Quantitative Reduction Grading Criteria [Time frame: From completion of surgery to postoperative low-dose CT assessment, assessed up to 2 weeks after surgery]
Secondary outcome measures (12)
- Total Operation Time Measured in Minutes [Time frame: From initial skin incision to completion of skin closure, assessed up to 8 hours]
- Number of Intraoperative C-Arm Fluoroscopy Shots [Time frame: From initial skin incision to completion of skin closure, assessed up to 8 hours]
- Intraoperative Blood Loss Measured 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 [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 [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 frame: From completion of surgery to the first documented radiographic evidence of fracture union, assessed up to 6 months after surgery]
- Radiographic Fracture Union Rate Assessed by Standard X-Ray [Time frame: From completion of surgery to the first documented radiographic evidence of fracture union, assessed up to 6 months after surgery]
- American Knee Society Score [Time frame: From baseline to 1 month, 3 months and 6 months after surgery]
- Lower Extremity Functional Scale [Time frame: From baseline to 1 month, 3 months and 6 months after surgery]
- EuroQol 5-Dimension 5-Level Health-Related Quality of Life [Time frame: From baseline to 1 month, 3 months and 6 months after surgery]
- EuroQol Visual Analogue Scale Score [Time frame: From baseline to 1 month, 3 months and 6 months after surgery]
- Incidence of Intraoperative Complications [Time frame: From initial skin incision to completion of skin closure, assessed up to 8 hours]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Aerospace Center Hospital — Beijing
- Beijing Jishuitan Hospital — Beijing
Identifiers
NCT: NCT07738406 · Ji-Lun [K2026] No. [189]-00