The Difference of Two and Three Fluoroscopic Views of Sacrum for Percutaneous Sacroiliac Screw Insertion in High Energy Posterior Pelvic Ring Injured Patients

N/AActive Not RecruitingNCT07571798

Chonburi hospital16 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

High-energy Trauma Sacral Fractures Posterior Pelvic Ring Injury

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Operative time

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)

Time frame: perioperative record

Secondary Outcomes

Radiation Exposure Time

Cumulative fluoroscopy time in seconds; From the first fluoroscopic image to the final image confirming guide pin placement

Time frame: Perioperative record

Neurological complications by physical examinations and symptoms

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)

Time frame: Immediate postoperative to two months after operation

Screw malposition

Screw malpositions of S1 screw (yes or no) include cortical breakage (sacral ala, endplate, anterior cortex, ilium), foraminal penetration and canal penetration

Time frame: Two months after operation, Postoperative CT scan will be evaluated for screw position.