Robot Assisted Treatment Versus Conventional Surgery for Tile B and C Pelvic Fractures

Официальное название

Comparing the Efficacy and Safety of Robot Assisted Treatment Versus Conventional Surgery in Patients With Tile B and C Pelvic Fractures

Обзор

This prospective randomized controlled trial aims to compare the efficacy and safety of robot assisted treatment versus conventional surgery in patients with Tile B and C pelvic fractures. Eligible patients will be stratified according to Tile fracture classification and randomly assigned in a 1:1 ratio to receive either robot assisted minimally invasive fixation or conventional surgical treatment. Primary and secondary outcomes include pain relief, early mobilization, functional recovery, imaging outcomes, perioperative complications, venous thromboembolism events, laboratory parameters, opioid consumption, and healthcare resource utilization. The study aims to provide evidence for optimizing surgical treatment strategies for unstable pelvic fractures.

Подробное описание

This study is a prospective, single center, stratified randomized controlled trial designed to compare the efficacy and safety of robot assisted treatment versus conventional surgery in patients with Tile B and C pelvic fractures.

A total of 88 patients will be enrolled and randomly assigned in a 1:1 ratio to either the robot assisted treatment group or the conventional surgery group. Randomization will be stratified according to Tile fracture classification (Tile B or Tile C) using a computer generated randomization sequence.

Eligible participants include adult patients diagnosed with Tile B or Tile C pelvic fractures within 3 weeks after injury. The primary objective is to compare perioperative outcomes, pain control, early mobilization, functional recovery, imaging outcomes, complications, opioid consumption, and healthcare resource utilization between treatment strategies.

Patients in the robot assisted treatment group will undergo robot assisted minimally invasive fixation using robotic navigation assisted percutaneous screw placement. Patients in the conventional surgery group will undergo standard open surgical fixation according to fracture characteristics and surgeon judgment.

Outcome measures include pain scores, Majeed pelvic function score, EQ 5D, SMFA, imaging evaluation of fracture healing, laboratory parameters, venous thromboembolism events, opioid consumption, perioperative indicators, complications, and healthcare costs. Follow up assessments will be performed at postoperative day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year.

The results of this study may provide evidence regarding the optimal surgical treatment strategy for Tile B and C pelvic fractures.

Вмешательства

• Процедура Robot Assisted Minimally Invasive Fixation
  Robot assisted minimally invasive fixation is performed using robotic navigation assisted percutaneous screw placement for stabilization of unstable pelvic fractures.

Первичные конечные точки

• Visual Analog Scale (VAS) for Pain [Срок оценки: At 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 12 hours, day 1, day 2, day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment]
• Majeed Pelvic Function Score [Срок оценки: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment]

Вторичные конечные точки (11)

• EuroQol 5-Dimension 3-Level Questionnaire [Срок оценки: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment]
• Short Musculoskeletal Function Assessment (SMFA) [Срок оценки: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment]
• Imaging Outcomes and Fracture Healing [Срок оценки: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment]
• Complication [Срок оценки: From treatment initiation to 1 year follow up]
• Opioid Consumption [Срок оценки: Postoperative Days 0-3]
• Serum C-Reactive Protein Level [Срок оценки: Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment.]
• D-Dimer Level [Срок оценки: Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment.]
• Hemoglobin Level [Срок оценки: Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment.]
• Operative Time [Срок оценки: Perioperative]
• Intraoperative Blood Loss [Срок оценки: Perioperative]
• Length of Surgical Incision [Срок оценки: Perioperative]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Diagnosis of Tile B or Tile C pelvic fracture
• Injury duration less than 3 weeks
• Ability to provide written informed consent

Критерии исключения

• Severe open injury or skin infection at the surgical site
• Hemodynamic instability preventing anesthesia or surgery
• Severe psychiatric disorders or dementia
• Severe obesity affecting imaging quality
• Severe systemic diseases preventing surgery
• Pathological fracture
• Current chemotherapy, radiotherapy, systemic corticosteroid therapy, or growth factor therapy

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Lu Z, Xiuxiu H, Xing B. Retrospective analysis of the use of orthopedic reduction robots in treating low-energy osteoporotic unstable pelvic fractures in the elderly. J Orthop Surg Res. 2025 Sep 26;20(1):844. doi: 10.1186/s13018-025-06258-1. PMID 41013720
• Zwingmann J, Konrad G, Kotter E, Sudkamp NP, Oberst M. Computer-navigated iliosacral screw insertion reduces malposition rate and radiation exposure. Clin Orthop Relat Res. 2009 Jul;467(7):1833-8. doi: 10.1007/s11999-008-0632-6. Epub 2008 Nov 26. PMID 19034594
• Hoffmann MF, Yilmaz E, Norvel DC, Schildhauer TA. Navigated iliac screw placement may reduce radiation and OR time in lumbopelvic fixation of unstable complex sacral fractures. Eur J Orthop Surg Traumatol. 2021 Oct;31(7):1427-1433. doi: 10.1007/s00590-021-02892-7. Epub 2021 Feb 16. PMID 33590317
• Gericke L, Fritz A, Osterhoff G, Josten C, Pieroh P, Hoch A. Percutaneous operative treatment of fragility fractures of the pelvis may not increase the general rate of complications compared to non-operative treatment. Eur J Trauma Emerg Surg. 2022 Oct;48(5):3729-3735. doi: 10.1007/s00068-021-01660-w. Epub 2021 Apr 3. PMID 33811488
• Ran D, Wang C. Efficacy and safety of different fixation methods for unstable anterior pelvic ring fractures: a Bayesian network meta-analysis. Ann Med. 2025 Dec;57(1):2563000. doi: 10.1080/07853890.2025.2563000. Epub 2025 Oct 6. PMID 41054280
• Lu S, Liu F, Xu W, Zhou X, Li L, Zhou D, Li Q, Dong J. Management of Open Tile C Pelvic Fractures and Their Outcomes: A Retrospective Study of 30 Cases. Ther Clin Risk Manag. 2022 Sep 10;18:929-937. doi: 10.2147/TCRM.S378740. eCollection 2022. PMID 36119388
• de Ridder VA, Whiting PS, Balogh ZJ, Mir HR, Schultz BJ, Routt MC. Pelvic ring injuries: recent advances in diagnosis and treatment. OTA Int. 2023 Jun 16;6(3 Suppl):e261. doi: 10.1097/OI9.0000000000000261. eCollection 2023 Jun. PMID 37533441
• Tienpratarn W, Nakpipat N, Yuksen C, Wongwaisayawan S, Phootothum Y, Jaiboon S. Clinical Associated Factors of Tile B/C Type of Pelvic Ring Fractures; a Retrospective Cross-sectional study. Arch Acad Emerg Med. 2024 May 12;12(1):e49. doi: 10.22037/aaem.v12i1.2243. eCollection 2024. PMID 38962370

Идентификаторы

NCT: NCT07624942 · K20260304

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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