Pelvic Fracture
Conditions
Keywords
Pelvic Fracture, Robot Assisted Surgery
Brief summary
This prospective randomized controlled trial aims to compare the efficacy and safety of robot assisted treatment versus conventional surgery in patients with Tile B and C pelvic fractures. Eligible patients will be stratified according to Tile fracture 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, imaging outcomes, perioperative complications, venous thromboembolism events, laboratory parameters, opioid consumption, and healthcare resource utilization. The study aims to provide evidence for optimizing surgical treatment strategies for unstable pelvic fractures.
Detailed description
This study is a prospective, single center, stratified randomized controlled trial designed to compare the efficacy and safety of robot assisted treatment versus conventional surgery in patients with Tile B and C pelvic fractures. A total of 88 patients will be enrolled and randomly assigned in a 1:1 ratio to either the robot assisted treatment group or the conventional surgery group. Randomization will be stratified according to Tile fracture classification (Tile B or Tile C) using a computer generated randomization sequence. Eligible participants include adult patients diagnosed with Tile B or Tile C pelvic fractures within 3 weeks after injury. The primary objective is to compare perioperative outcomes, pain control, early mobilization, functional recovery, imaging outcomes, complications, opioid consumption, and healthcare resource utilization between treatment strategies. Patients in the robot assisted treatment group will undergo robot assisted minimally invasive 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, laboratory parameters, venous thromboembolism events, 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 Tile B and C pelvic fractures.
Interventions
Robot assisted minimally invasive fixation is performed using robotic navigation assisted percutaneous screw placement for stabilization of unstable pelvic fractures.
Sponsors
Junbo Liang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Diagnosis of Tile B or Tile C pelvic fracture * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) for Pain | 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 | 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 | At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EuroQol 5-Dimension 3-Level Questionnaire | At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment | 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. |
| Short Musculoskeletal Function Assessment (SMFA) | At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment | Musculoskeletal function assessed using the 46-item Short Musculoskeletal Function Assessment (SMFA). Raw questionnaire scores are transformed to a standardized score ranging from 0 to 100. Higher scores indicate worse musculoskeletal function and greater disability. |
| Imaging Outcomes and Fracture Healing | At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment | Assessment of fracture healing, secondary displacement, bone mineral density changes, and muscle mass changes using pelvic CT and imaging examinations. |
| Complication | From treatment initiation to 1 year follow up | — |
| Opioid Consumption | Postoperative Days 0-3 | Assessment of cumulative opioid consumption during hospitalization |
| Serum C-Reactive Protein Level | Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment. | — |
| D-Dimer Level | Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment. | — |
| Hemoglobin Level | Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment. | — |
| Operative Time | Perioperative | Duration of surgery measured in minutes. |
| Intraoperative Blood Loss | Perioperative | Estimated intraoperative blood loss measured in milliliters. |
| Length of Surgical Incision | Perioperative | Length of skin incision measured in centimeters. |
Contacts
CONTACTJunbo Liang, Dr.
Outcome results
None listed