High-energy Trauma, Posterior Pelvic Ring Injury, Sacral Fractures
Conditions
Keywords
Sacral fracture, Fluoroscopic view, Orthopedic trauma, Percutaneous SI screw, Pelvic injury
Brief summary
The goal of this clinical trial is to learn about the surgical techniques of percutaneous sacroiliac screw fixation both the two-view fluoroscopic technique (sacral inlet and outlet views) and the standard three-view fluoroscopic technique (lateral, sacral inlet, and sacral outlet views). The main questions it aims to answer is: • Is there any difference of the operative time, intraoperative radiation exposure time, screw malposition rate, and postoperative neurological complication rate for percutaneous pelvic screw fixation between two techniques? Researchers will compare two surgical techniques of percutaneous sacroiliac screw fixation in high energy posterior pelvic ring injured patients. Participants will: * Be examined neurological status carefully before and after the operation * Get both preoperative and postoperative CT scan * Undergo the percutaneous sacroiliac screw(s) fixation with or without anterior plating fixation
Interventions
PROCEDUREPercutaneous sacroiliac screw fixation using two or three fluoroscopic views
Surgeon will insert the SI screw percutaneously using sacral inlet, sacral outlet fluoroscopic views with or without lateral sacral view
Sponsors
Chonburi hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Paticipants will undergo the operation with only one technique (either two-view fluoroscopy or three-view fluoroscopy)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with traumatic posterior pelvic ring or sacral fractures indicated percutaneous screw fixation. 2. Patients who are fully conscious, possess decision-making capacity, and can provide informed consent.
Exclusion criteria
1. Presence of severe sacral dysmorphism (sacral dysmorphic score \> 70 and absence of osseous corridor) 2. Concomitant diagnosis of osteoporosis or age more than 60 years 3. Age under 20 years or evidence of skeletal immaturity 4. Pregnancy 5. Highly comminuted sacral fractures precluding accurate intraoperative assessment of the screw trajectory 6. Pre-existing lumbosacral neurological deficits prior to surgery Withdrawal Criteria: 1. Intraoperative necessity to convert to an alternative surgical method (e.g., inability to safely proceed with percutaneous fixation). 2. Absence of postoperative computed tomography (CT) scan 3. Loss to follow-up within 2 months postoperatively
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | perioperative record | Operative time in minutes that takes for insertion of guide pin of cannulated SI screw; From the time of skin incision to the final acceptable positioning of the guide pin (prior to screw insertion) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiation Exposure Time | Perioperative record | Cumulative fluoroscopy time in seconds; From the first fluoroscopic image to the final image confirming guide pin placement |
| Neurological complications by physical examinations and symptoms | Immediate postoperative to two months after operation | Neurological examinations will be assessed and recorded by an independent orthopedic resident blinded to the allocation. The evaluations include radiation pain by visual analog score, L5 and S1 motor power by physical examination motor grading scale, L5 and S1 sensation deficit (yes or no), perianal sensation deficit (yes or no), bowel bladder symptoms (yes or no), sphincter tone deficit (yes or no) |
| Screw malposition | Two months after operation, Postoperative CT scan will be evaluated for screw position. | Screw malpositions of S1 screw (yes or no) include cortical breakage (sacral ala, endplate, anterior cortex, ilium), foraminal penetration and canal penetration |
Countries
Thailand
Contacts
PRINCIPAL_INVESTIGATORPanachol Leangtanom
Chonburi hospital
Outcome results
None listed