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

Официальное название

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

Обзор

The goal of this clinical trial is to compare the clinical effectiveness and safety of robot-assisted autonomous closed reduction versus traditional manual closed reduction in adult patients aged 18 to 80 years with acute, closed intertrochanteric femoral fractures (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association \[AO/OTA\] classification 31-A). The main question it aims to answer is: Whether robot-assisted autonomous closed reduction can achieve a significantly higher rate of excellent and good bone fracture reduction compared to traditional manual reduction, as rigorously evaluated by low-dose computed tomography (CT) and a three-dimensional (3D) quantitative standard. Researchers will compare the robot-assisted autonomous closed reduction group (intervention group) to the traditional manual closed reduction group (control group) to see if the robotic system significantly improves 3D anatomical reduction precision, reduces intraoperative fluoroscopy times and radiation doses, shortens operation times, and ultimately enhances long-term clinical hip functions and health-related quality of life. Participants will be asked to do the following tasks: Complete baseline medical screening, standard hip X-rays, and bilateral full-length thin-layer CT scans before the surgery. Undergo a 1:1 randomized allocation after anesthesia to receive either robot-assisted autonomous closed reduction or traditional experience-based manual closed reduction, both followed by conventional proximal femoral intramedullary nailing internal fixation. Receive post-operative low-dose CT scans before discharge or within 2 weeks after surgery to evaluate the fracture reduction quality. Follow a standardized Enhanced Recovery After Surgery (ERAS) rehabilitation pathway and attend scheduled follow-up visits at 1, 3, and 6 months after the surgery to monitor bone healing, hip functions, and quality of life

Вмешательства

• Процедура Robot-assisted closed reduction and internal fixation
  The key distinguishing feature of this intervention is the transition from empirical, experience-based traction to computer-planned, quantitatively-controlled reduction. The robotic system creates an individualized 3D model based on pre-operative thin-layer CT and automatically calculates precise fragment displacement parameters. Unlike manual methods, the reduction pathway is executed or guided via real-time spatial navigation and digital monitoring with strict safety interlocking mechanisms. T
• Процедура Conventional manual closed reduction and internal fixation
  This intervention relies entirely on the surgical team's clinical experience, using a standard orthopedic traction table or manual manipulation to achieve bone alignment. Unlike the experimental group, no intelligent robotic systems, 2D-3D registration software, or spatial tracking devices are permitted during any stage of the operation. Reduction quality is evaluated intraoperatively using routine two-dimensional C-arm fluoroscopy (AP and lateral views) rather than computerized 3D planning. If

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 Hip Function Assessed by Harris Hip Score (HHS) [Срок оценки: From baseline to 1 month, 3 months, and 6 months after surgery]
• Change from Baseline in Quality of Life Assessed by EQ-5D-5L Questionnaire [Срок оценки: From baseline to 1 month, 3 months, and 6 months after surgery]
• Time to Radiographic Bone Healing Assessed by Standard Two-View X-Ray [Срок оценки: From completion of surgery to the first documented radiographic evidence of fracture union, assessed up to 6 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 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 the occurrence of postoperative complications, assessed up to 6 months after surgery]
• Length of Hospital Stay Measured in Days [Срок оценки: From hospital admission to hospital discharge, assessed up to 30 days]
• 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]
• Incidence of Reoperation [Срок оценки: From completion of surgery to reoperation assessment, assessed up to 6 months after surgery]

Критерии участия

Inclusion Criteria：

• Age 18 to 80 years, inclusive.
• Male or female participants.
• Acute, closed intertrochanteric femoral fracture.
• AO/OTA classification 31-A intertrochanteric femoral fracture.
• Fracture requiring closed reduction and proximal femoral intramedullary nailing.
• Injury-to-surgery interval no more than 14 days.
• Participant or legally authorized representative is fully informed about the study.
• Written informed consent voluntarily provided by the participant or legally authorized representative.

Exclusion Criteria：

• Open fracture.
• Pathological fracture.
• Old fracture with an injury-to-surgery interval greater than 14 days.
• Multiple fractures.
• Previous surgery involving the affected hip joint.
• Deformity of the affected hip joint.
• Severe osteoarthritis of the affected hip joint.
• Significant neuromuscular disease affecting lower limb function.
• Significant neuromuscular disease affecting postoperative rehabilitation.
• Severe systemic comorbidity that makes the participant unable to tolerate anesthesia or surgery.
• Severe organ dysfunction that makes the participant unable to tolerate anesthesia or surgery.
• Pregnancy.
• Lactation.
• Cognitive impairment that prevents compliance with postoperative follow-up or rehabilitation protocols.
• Active psychiatric illness that prevents compliance with postoperative follow-up or rehabilitation protocols.
• Other condition that prevents compliance with postoperative follow-up or rehabilitation protocols.
• Current participation in another clinical trial that may interfere with evaluation of this study's outcomes.

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

Публикации

• Veronese N, Maggi S. Epidemiology and social costs of hip fracture. Injury. 2018 Aug;49(8):1458-1460. doi: 10.1016/j.injury.2018.04.015. Epub 2018 Apr 20. PMID 29699731
• Graulich T, Omar M, Sehmisch S, Liodakis E. Controversies in the Treatment Strategies of Intertrochanteric Fractures: A Scoping Review and Discussion of a Literature-Based Algorithm. J Clin Med. 2025 Mar 24;14(7):2200. doi: 10.3390/jcm14072200. PMID 40217650
• Baumgaertner MR, Curtin SL, Lindskog DM, Keggi JM. The value of the tip-apex distance in predicting failure of fixation of peritrochanteric fractures of the hip. J Bone Joint Surg Am. 1995 Jul;77(7):1058-64. doi: 10.2106/00004623-199507000-00012. PMID 7608228
• Chang SM, Zhang YQ, Ma Z, Li Q, Dargel J, Eysel P. Fracture reduction with positive medial cortical support: a key element in stability reconstruction for the unstable pertrochanteric hip fractures. Arch Orthop Trauma Surg. 2015 Jun;135(6):811-8. doi: 10.1007/s00402-015-2206-x. Epub 2015 Apr 4. PMID 25840887
• Liu P, Jin D, Zhang C, Gao Y. Revision surgery due to failed internal fixation of intertrochanteric femoral fracture: current state-of-the-art. BMC Musculoskelet Disord. 2020 Aug 22;21(1):573. doi: 10.1186/s12891-020-03593-8. PMID 32828132
• Zhao JX, Li C, Ren H, Hao M, Zhang LC, Tang PF. Evolution and Current Applications of Robot-Assisted Fracture Reduction: A Comprehensive Review. Ann Biomed Eng. 2020 Jan;48(1):203-224. doi: 10.1007/s10439-019-02332-y. Epub 2019 Jul 29. PMID 31359265
• Kou W, Zhou P, Lin J, Kuang S, Sun L. Technologies evolution in robot-assisted fracture reduction systems: a comprehensive review. Front Robot AI. 2023 Nov 22;10:1315250. doi: 10.3389/frobt.2023.1315250. eCollection 2023. PMID 38077454
• Bai L, Yang J, Chen X, Sun Y, Li X. Medical Robotics in Bone Fracture Reduction Surgery: A Review. Sensors (Basel). 2019 Aug 18;19(16):3593. doi: 10.3390/s19163593. PMID 31426577

Идентификаторы

NCT: NCT07738458 · Jilun [K2026] No. [187]-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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