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.
Age ≥ 60 years
Low energy trauma
Diagnosis of osteoporosis
Diagnosis of FFP3 or FFP4 fragility fractures of the pelvis
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
Parallel
Robot Assisted Minimally Invasive Fixation
Procedure/SurgeryRobot assisted minimally invasive fixation is performed using robotic navigation assisted percutaneous screw placement for stabilization of unstable pelvic fragility fractures.
Conventional Open Fixation
Procedure/SurgeryConventional open reduction and internal fixation for FFP3-4 pelvic fragility fractures performed without robotic assistance.
Visual Analog Scale (VAS) for Pain
Visual Analog Scale (VAS) for pain. Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain severity.
Majeed Pelvic Function Score
The Majeed Pelvic Function Score is used to evaluate functional recovery after pelvic fracture treatment. Scores range from 0 to 100, with higher scores indicating better functional outcomes and quality of life.
EuroQol 5-Dimension 3-Level Questionnaire
Health related quality of life assessed using the EuroQol 5-Dimension 3-Level Questionnaire (EQ-5D-3L). The EQ-5D index score ranges from values below 0 (health states considered worse than death) to 1.0 (full health). Higher scores indicate better health related quality of life.
Fracture Healing
Complication
Opioid Consumption
Assessment of cumulative opioid consumption during hospitalization
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Junbo Liang
Lead sponsor
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Sponsor institution
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