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

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

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.

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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