Robot Assisted Minimally Invasive Treatment Versus Conventional Surgery for FFP3-4 Fragility Fractures of the Pelvis in Elderly Patients

Официальное название

Comparing the Efficacy and Safety of Robot Assisted Minimally Invasive Treatment Versus Conventional Surgery in Elderly Patients With FFP3-4 Fragility Fractures of the Pelvis

Обзор

This prospective randomized controlled trial aims to compare the efficacy and safety of robot assisted minimally invasive treatment versus conventional surgery in elderly patients with FFP3-4 fragility fractures of the pelvis. Eligible patients will be stratified according to FFP 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, perioperative complications, venous thromboembolism events, laboratory parameters, imaging outcomes, and healthcare resource utilization. The study aims to provide evidence for optimizing surgical treatment strategies in elderly patients with unstable pelvic fragility fractures.

Подробное описание

This study is a prospective, single center, stratified randomized controlled trial designed to compare the efficacy and safety of robot assisted minimally invasive treatment versus conventional surgery in elderly patients with FFP3-4 fragility fractures of the pelvis.

A total of 88 patients will be enrolled and randomly assigned in a 1:1 ratio to either the robot assisted minimally invasive treatment group or the conventional surgery group. Randomization will be stratified according to FFP classification (FFP3 or FFP4) using a computer generated randomization sequence.

Eligible participants include patients aged 60 years or older diagnosed with osteoporosis related FFP3 or FFP4 pelvic fragility fractures caused by low energy trauma. The primary objective is to compare perioperative outcomes, pain control, early mobilization, functional recovery, imaging outcomes, venous thromboembolism events, laboratory parameters, complications, opioid consumption, and healthcare resource utilization between treatment strategies.

Patients in the robot assisted treatment group will undergo robot assisted minimally invasive pelvic 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, venous thromboembolism events, laboratory parameters, muscle mass changes, bone mineral density, 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 elderly patients with unstable pelvic fragility 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 fragility fractures.
• Процедура Conventional Open Fixation
  Conventional open reduction and internal fixation for FFP3-4 pelvic fragility fractures performed without robotic assistance.

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 (10)

• 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]
• 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: Time Frame: Postoperative Days 0-3]
• 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]
• Serum C-Reactive Protein Level [Срок оценки: Time Frame: Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment]
• Hemoglobin Level [Срок оценки: Time Frame: 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 ≥ 60 years
• Low energy trauma
• Diagnosis of osteoporosis
• Diagnosis of FFP3 or FFP4 fragility fractures of the pelvis
• 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

Китай · 1 центр

• No. 150 Ximen Road — Linhai

Публикации

• GBD 2019 Fracture Collaborators. Global, regional, and national burden of bone fractures in 204 countries and territories, 1990-2019: a systematic analysis from the Global Burden of Disease Study 2019. Lancet Healthy Longev. 2021 Sep;2(9):e580-e592. doi: 10.1016/S2666-7568(21)00172-0. PMID 34723233
• Hutchings L, Roffey DM, Lefaivre KA. Fragility Fractures of the Pelvis: Current Practices and Future Directions. Curr Osteoporos Rep. 2022 Dec;20(6):469-477. doi: 10.1007/s11914-022-00760-9. Epub 2022 Nov 7. PMID 36342642
• Ali KA, He L, Li W, Zhang W, Huang H. Sleep quality and psychological health in patients with pelvic and acetabulum fractures: a cross-sectional study. BMC Geriatr. 2024 Apr 4;24(1):314. doi: 10.1186/s12877-024-04929-y. PMID 38575871
• Rommens PM, Arand C, Hofmann A, Wagner D. When and How to Operate Fragility Fractures of the Pelvis? Indian J Orthop. 2019 Jan-Feb;53(1):128-137. doi: 10.4103/ortho.IJOrtho_631_17. PMID 30905993
• Hitchener WR, Cenedella RJ. Absolute rates of sterol synthesis estimated from [3H]water for bovine lens epithelial cells in culture. J Lipid Res. 1985 Dec;26(12):1455-63. PMID 4086948
• Lau-Ting C. Asymptomatic hepatitis B antigen(s) carriers in Singapore: serological reassessment. Singapore Med J. 1988 Feb;29(1):11-3. No abstract available. PMID 3406758
• Jiang Y, Qi X, Cui H, Huang Y, Lv Y, Yang Y, Yao X, Yang D. The Inflammation-Energy Metabolism Axis: A Central Driver of Sarcopenia-Osteoporosis: A Narrative Review. Calcif Tissue Int. 2026 Jan 7;117(1):9. doi: 10.1007/s00223-025-01473-8. PMID 41495343
• Rommens PM, Arand C, Hopf JC, Mehling I, Dietz SO, Wagner D. Progress of instability in fragility fractures of the pelvis: An observational study. Injury. 2019 Nov;50(11):1966-1973. doi: 10.1016/j.injury.2019.08.038. Epub 2019 Aug 27. PMID 31492514

Идентификаторы

NCT: NCT07639619 · K20260303

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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