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

Официальное название

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)

Обзор

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.

Вмешательства

• Устройство 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
• Устройство 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.

Первичные конечные точки

• Rate of Excellent or Good Closed Fracture Reduction Assessed by Postoperative Low-Dose CT-Based 3D Quantitative Reduction Grading Criteria [Срок оценки: From completion of surgery to postoperative low-dose CT assessment, assessed up to 2 weeks after surgery]

Вторичные конечные точки (12)

• Total Operation Time Measured in Minutes [Срок оценки: From initial skin incision to completion of skin closure, assessed up to 8 hours]
• Number of Intraoperative C-Arm Fluoroscopy Shots [Срок оценки: From initial skin incision to completion of skin closure, assessed up to 8 hours]
• Intraoperative Blood Loss Measured in Milliliters [Срок оценки: From initial skin incision to completion of skin closure, assessed up to 8 hours]
• Length of Hospital Stay Measured in Days [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From completion of surgery to the first documented radiographic evidence of fracture union, assessed up to 6 months after surgery]
• American Knee Society Score [Срок оценки: From baseline to 1 month, 3 months and 6 months after surgery]
• Lower Extremity Functional Scale [Срок оценки: From baseline to 1 month, 3 months and 6 months after surgery]
• EuroQol 5-Dimension 5-Level Health-Related Quality of Life [Срок оценки: From baseline to 1 month, 3 months and 6 months after surgery]
• EuroQol Visual Analogue Scale Score [Срок оценки: From baseline to 1 month, 3 months and 6 months after surgery]
• Incidence of Intraoperative Complications [Срок оценки: From initial skin incision to completion of skin closure, assessed up to 8 hours]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Aerospace Center Hospital — Пекин
• Beijing Jishuitan Hospital — Пекин

Идентификаторы

NCT: NCT07738406 · Ji-Lun [K2026] No. [189]-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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