Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07571798

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

High-energy Trauma Posterior Pelvic Ring Injury Sacral Fractures

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chonburi Hospital, 69 Moo 2 Sukhumvit Road

Chon Buri, Changwat Chon Buri, 20000, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with traumatic posterior pelvic ring or sacral fractures indicated percutaneous screw fixation.
  • Patients who are fully conscious, possess decision-making capacity, and can provide informed consent.

Exclusion criteria

  • Presence of severe sacral dysmorphism (sacral dysmorphic score > 70 and absence of osseous corridor)
  • Concomitant diagnosis of osteoporosis or age more than 60 years
  • Age under 20 years or evidence of skeletal immaturity
  • Pregnancy
  • Highly comminuted sacral fractures precluding accurate intraoperative assessment of the screw trajectory
  • Pre-existing lumbosacral neurological deficits prior to surgery

Withdrawal Criteria:

  • Intraoperative necessity to convert to an alternative surgical method (e.g., inability to safely proceed with percutaneous fixation).
  • Absence of postoperative computed tomography (CT) scan
  • Loss to follow-up within 2 months postoperatively

Treatment and study plan

Percutaneous sacroiliac screw fixation using two or three fluoroscopic views

Procedure

Surgeon will insert the SI screw percutaneously using sacral inlet, sacral outlet fluoroscopic views with or without lateral sacral view

Primary outcomes

  1. Operative time

    Time frame: 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 outcomes

  1. Radiation Exposure Time

    Time frame: Perioperative record

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

  2. Neurological complications by physical examinations and symptoms

    Time frame: 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)

  3. Screw malposition

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Chonburi hospital

Other Gov

Registry information

Official study title

The Difference of Two and Three Fluoroscopic Views of Sacrum for Percutaneous Sacroiliac Screw Insertion in High Energy Posterior Pelvic Ring Injured Patients, a Double-blinded Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.