Robot-Assisted Closed Reduction and Internal Fixation for Extra-Articular Distal Tibial Fractures

Официальное название

Key Technology Research and Development for Intelligent Minimally Invasive Precision Treatment of Fractures (Sub-project 4: A Randomized Controlled Trial of Robot-Assisted Closed Reduction and Internal Fixation for Distal Tibial Fractures)

Обзор

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.

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, the fracture is fixed with a distal tibial locking plate via the minimally invasive percutaneous
• Процедура Traditional 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.

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 12 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 12 months after surgery]
• Foot and Ankle Ability Measure-Activities of Daily Living Score [Срок оценки: From baseline to 1 month, 3 months, 6 months and 12 months after surgery]
• Lower Extremity Functional Scale Score [Срок оценки: From baseline to 1 month, 3 months, 6 months and 12 months after surgery]
• EuroQol 5-Dimension 5-Level Health Index [Срок оценки: From baseline to 1 month, 3 months, 6 months and 12 months after surgery]
• EuroQol Visual Analogue Scale Score [Срок оценки: From baseline to 1 month, 3 months, 6 months and 12 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

• 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)

Критерии исключения

• 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

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: NCT07733271 · Ji-Lun [K2026] No. [190]-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗