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

Официальное название

Robot-Assisted Versus Traditional Closed Reduction and Internal Fixation for Femoral Shaft Fractures: A Randomized Controlled Trial

Обзор

The goal of this clinical trial is to evaluate the safety and efficacy of robot-assisted closed reduction for patients with femoral shaft fractures. The main questions it aims to answer are: Does robot-assisted closed reduction provide a statistically significant improvement in the excellent and good reduction rates compared to conventional surgeon-performed reduction? How do the two reduction methods compare in terms of surgical efficiency, fracture healing, and patient functional outcomes? Researchers will compare the robot-assisted closed reduction group to the conventional surgeon-performed reduction group to see if robot-assisted surgery improves the precision of fracture reduction, stability of alignment, and post-operative functional recovery while minimizing trauma. Participants will: Undergo standardized screening to ensure they meet the inclusion criteria for acute, unilateral, closed femoral shaft fractures (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association \[AO/OTA\] classification 32). Be randomized in a 1:1 ratio to receive either robot-assisted closed reduction or traditional surgeon-performed closed reduction, both followed by internal fixation. Complete standardized perioperative management and follow-up assessments at 1, 3, 6, and 12 months post-surgery, including functional scales such as the Lower Extremity Functional Scale (LEFS) and the EuroQol Five-Dimensional Five-Level questionnaire (EQ-5D-5L), as well as radiographic imaging to monitor bone healing and potential complications.

Вмешательства

• Процедура Robot-Assisted Closed Reduction
  Patients in this group will undergo robotic-assisted closed reduction of the femoral shaft fracture. The procedure utilizes a robotic system for intraoperative navigation and automated reduction planning based on preoperative computed tomography (CT) imaging. The robotic system assists the surgeon in achieving precise fracture alignment. Following successful reduction, routine internal fixation (intramedullary nailing) will be performed by the surgeon.
• Процедура Conventional Closed Reduction
  Patients in this group will undergo traditional manual closed reduction of the femoral shaft fracture. The reduction will be performed by the surgeon using standardized traction and manipulation techniques under real-time fluoroscopic guidance. Following manual reduction, routine internal fixation (intramedullary nailing) will be performed by the surgeon.

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]
• Intraoperative Blood Loss Measured in Milliliters [Срок оценки: From initial skin incision to completion of skin closure, assessed up to 8 hours]
• Change from Baseline in Lower Extremity Functional Scale Score (LEFS) [Срок оценки: From baseline to 1 month, 3 months, 6 months, and 12 months after surgery]
• Change from Baseline in EuroQol 5-Dimension 5-Level Score( EQ-5D-5L) [Срок оценки: From baseline to 1 month, 3 months, 6 months, and 12 months after surgery]
• Number of Intraoperative C-Arm Fluoroscopy Shots [Срок оценки: From initial skin incision to completion of skin closure, assessed up to 8 hours]
• 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]
• Incidence of Reoperation [Срок оценки: From completion of surgery to reoperation assessment, assessed up to 12 months after surgery]
• Length of Hospital Stay Measured in Days [Срок оценки: From hospital admission to hospital discharge, assessed up to 30 days]
• 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]
• Incidence of Intraoperative Complications [Срок оценки: From initial skin incision to completion of skin closure, assessed up to 8 hours]
• Incidence of Postoperative Complications [Срок оценки: From completion of surgery to postoperative complication assessment, assessed up to 12 months after surgery]

Критерии участия

Inclusion Criteria：

• Age 18 to 80 years, inclusive.
• Unilateral, acute, closed femoral shaft fracture.
• AO/OTA classification 32-A, 32-B, or 32-C femoral shaft fracture.
• Time from injury to surgery no more than 21 days.
• Ability to walk independently before injury, with or without assistive devices.
• Ability to provide written informed consent.

Exclusion Criteria：

• Open fracture.
• Multiple severe trauma requiring immediate priority management.
• Asymmetry of the lower limbs.
• History of ipsilateral femoral shaft malunion.
• History of ipsilateral femoral deformity that significantly affects assessment of - limb rotation or length.
• Ipsilateral fracture at another site.
• Pathological fracture caused by tumor, metabolic bone disease, or other underlying bone pathology.
• Complex hardware from previous ipsilateral surgery.
• History of ipsilateral surgery that significantly affects clinical or radiographic evaluation.
• Active infection.
• Severe underlying medical condition that makes the patient unable to tolerate surgery.
• Cognitive impairment that prevents study participation or follow-up.
• Poor compliance with study procedures or follow-up.
• Pregnancy or lactation.
• Judged by the investigators to be unsuitable for enrollment.
• Unable to complete the planned follow-up period.
• Refusal to undergo randomization.
• Refusal to participate in the clinical study.

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 · 1 центр

• Beijing Jishuitan Hospital — Пекин

Идентификаторы

NCT: NCT07738380 · Ji-Lun [K2026] No. 188-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗