About this trial
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.
Eligibility criteria
Qualifiers
Age ≥ 60 years
Low energy trauma
Diagnosis of osteoporosis
Diagnosis of FFP3 or FFP4 fragility fractures of the pelvis
Disqualifiers
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
Trial design
Treatments tested in this trial
- Robot Assisted Minimally Invasive Fixation
- Conventional Open Fixation
Treatment groups
Sponsors and collaborators
Junbo Liang
Lead sponsor
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Sponsor institution