Fragility Fractures of the Pelvis (FFP), Osteoporosis
Conditions
Keywords
Fragility Fracture, Robot Assisted Surgery, pelvis
Brief summary
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.
Detailed description
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.
Interventions
Robot assisted minimally invasive fixation is performed using robotic navigation assisted percutaneous screw placement for stabilization of unstable pelvic fragility fractures.
PROCEDUREConventional Open Fixation
Conventional open reduction and internal fixation for FFP3-4 pelvic fragility fractures performed without robotic assistance.
Sponsors
Junbo Liang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
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. |
| Fracture Healing | At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment | — |
| Complication | From treatment initiation to 1 year follow up | — |
| Opioid Consumption | Time Frame: Postoperative Days 0-3 | Assessment of cumulative opioid consumption during hospitalization |
| 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. |
| Serum C-Reactive Protein Level | Time Frame: Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment | — |
| Hemoglobin Level | Time Frame: 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. |
Countries
China
Contacts
CONTACTJunbo Liang
Outcome results
None listed