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NCT Number: NCT07738406

Robot-Assisted Closed Reduction and Internal Fixation for Distal Femoral Fractures

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.

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Key information

Conditions

Supracondylar Femoral Fractures Femoral Fractures Fractures, Bone Leg Injuries Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aerospace Center Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robot-assisted closed reduction

Device

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.

Conventional fracture reduction and internal fixation

Device

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 outcomes

  1. 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

    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.

Secondary outcomes

  1. Total Operation Time Measured in Minutes

    Time frame: 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.

  2. Number of Intraoperative C-Arm Fluoroscopy Shots

    Time frame: 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.

  3. Intraoperative Blood Loss Measured in Milliliters

    Time frame: 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.

  4. Length of Hospital Stay Measured in Days

    Time frame: 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.

  5. 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

    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.

  6. 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

    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.

  7. 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

    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.

  8. American Knee Society Score

    Time frame: 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.

  9. Lower Extremity Functional Scale

    Time frame: 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.

  10. EuroQol 5-Dimension 5-Level Health-Related Quality of Life

    Time frame: 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.

  11. EuroQol Visual Analogue Scale Score

    Time frame: 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.

  12. Incidence of Intraoperative Complications

    Time frame: 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.

  13. Incidence of Postoperative Complications

    Time frame: 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.

  14. Incidence of Reoperation

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chunpeng Zhao, MD / Chief Physician

CONTACT

[email protected]

+86 18610012704

Sponsors and collaborators

Lead sponsor

Beijing Jishuitan Hospital

Other

Collaborators

  • Aerospace Center Hospital

Registry information

Official study 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)

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 31, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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