Robot Assisted Minimally Invasive Treatment Versus Conservative Treatment for Fragility Fractures of the Pelvis Type 1-2 in Elderly Patients

Официальное название

Comparing the Efficacy and Safety of Robot Assisted Minimally Invasive Treatment Versus Conservative Treatment in Elderly Patients With FFP1-2 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 conservative treatment in elderly patients with FFP1-2 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 standardized conservative treatment. Primary and secondary outcomes include pain relief, functional recovery, fracture progression, venous thromboembolism events, complications, and healthcare resource utilization. The study aims to provide evidence for optimizing treatment strategies in elderly patients with 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 conservative treatment in elderly patients with FFP1-2 fragility fractures of the pelvis.

A total of 152 patients will be enrolled and randomly assigned in a 1:1 ratio to either the robot assisted minimally invasive treatment group or the conservative treatment group. Randomization will be stratified according to FFP classification (FFP1 or FFP2) using a computer generated randomization sequence.

Eligible participants include patients aged 60 years or older diagnosed with osteoporosis related FFP1 or FFP2 pelvic fragility fractures caused by low energy trauma. The primary objective is to compare pain control, early weight bearing, functional recovery, fracture progression, venous thromboembolism events, and healthcare resource utilization between treatment strategies.

Patients in the robot assisted treatment group will undergo robot assisted minimally invasive pelvic fixation, while patients in the conservative treatment group will receive standardized nonoperative management including pain control, anticoagulation prophylaxis, rehabilitation, and osteoporosis treatment.

Outcome measures include pain scores, Majeed pelvic function score, EQ 5D, SMFA, imaging evaluation of fracture progression and healing, venous thromboembolism events, laboratory parameters, muscle mass changes, bone mineral density, opioid consumption, 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 treatment strategy for elderly patients with FFP1-2 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 pelvic fragility fractures.

Первичные конечные точки

• Visual Analog Scale (VAS) for Pain [Срок оценки: At 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 (8)

• 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]
• Fracture Progression and 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: Days 0-3 after treatment]
• Serum C-Reactive Protein Level [Срок оценки: Preoperatively and at day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment]
• D-Dimer Level [Срок оценки: Preoperatively and at day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment]
• Hemoglobin Level [Срок оценки: Preoperatively and at day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment]

Критерии участия

Критерии включения

Age ≥ 60 years Low energy trauma Diagnosis of osteoporosis Diagnosis of FFP1 or FFP2 fragility fractures of the pelvis Injury duration less than 3 weeks Ability to walk independently or with assistance before injury Ability to provide written informed consent

Критерии исключения

Severe open injury or skin infection at the surgical site Long term bedridden status or severe disability 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

• Zong Y, Li J, Li Z, Wang W. Minimally invasive surgery and conservative treatment achieve similar clinical outcomes in patients with type II fragility fractures of the pelvis. J Orthop Surg Res. 2025 Feb 27;20(1):210. doi: 10.1186/s13018-025-05581-x. PMID 40016842
• Haentjens P, Magaziner J, Colon-Emeric CS, Vanderschueren D, Milisen K, Velkeniers B, Boonen S. Meta-analysis: excess mortality after hip fracture among older women and men. Ann Intern Med. 2010 Mar 16;152(6):380-90. doi: 10.7326/0003-4819-152-6-201003160-00008. PMID 20231569
• Banierink H, Ten Duis K, de Vries R, Wendt K, Heineman E, Reininga I, IJpma F. Pelvic ring injury in the elderly: Fragile patients with substantial mortality rates and long-term physical impairment. PLoS One. 2019 May 28;14(5):e0216809. doi: 10.1371/journal.pone.0216809. eCollection 2019. PMID 31136589
• Yamamoto N, Someko H, Nakashima Y, Nakao S, Kaneko T, Tsuge T. Mortality following fragility fractures of the pelvis: Systematic review and meta-analysis. Injury. 2025 Oct;56(10):112618. doi: 10.1016/j.injury.2025.112618. Epub 2025 Jul 21. PMID 40714375
• Nakayama Y, Suzuki T, Kurozumi T, Watanabe Y. Progression to Rommens type IIIa fragility fracture of the pelvis managed by delayed open reduction and interdigitating screw fixation: A case report. Trauma Case Rep. 2023 Jan 13;43:100773. doi: 10.1016/j.tcr.2023.100773. eCollection 2023 Feb. PMID 36691632
• 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
• 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
• Lin YH, Shih YT, Teng MMH. The Impact of the "Osteo" Component of Osteosarcopenia on Fragility Fractures in Post-Menopausal Women. Int J Mol Sci. 2021 May 17;22(10):5256. doi: 10.3390/ijms22105256. PMID 34067582

Идентификаторы

NCT: NCT07636616 · K20260153

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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