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

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

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 Overview

• Status: Active, not recruiting
• Conditions: Sacral Fractures; High-energy Trauma; Posterior Pelvic Ring Injury
• Intervention / Treatment: Procedure: Percutaneous sacroiliac screw fixation using two or three fluoroscopic views

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Changwat Chon Buri
    • Chon Buri, Changwat Chon Buri, Thailand, 20000
      • Chonburi Hospital, 69 Moo 2 Sukhumvit Road

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Percutaneous SI screw insertion using two fluoroscopic views; Patients with posterior pelvic ring or sacral injuries resulting from high-energy trauma who required the sacroiliac screw fixation. Surgeon will insert the SI screw percutaneously using sacral inlet and sacral outlet fluoroscopic views	Procedure: Percutaneous 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
Active Comparator: Percutaneous SI screw insertion using three fluoroscopic views; Patients with posterior pelvic ring or sacral injuries resulting from high-energy trauma who required the sacroiliac screw fixation. Surgeon will insert the SI screw percutaneously using lateral, sacral inlet and sacral outlet fluoroscopic views	Procedure: Percutaneous 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	perioperative record

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation Exposure Time	Cumulative fluoroscopy time in seconds; From the first fluoroscopic image to the final image confirming guide pin placement	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)	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	Two months after operation, Postoperative CT scan will be evaluated for screw position.

Collaborators and Investigators

• Sponsor: Chonburi hospital
• Investigators: Principal Investigator: Panachol Leangtanom, Chonburi hospital

Publications and helpful links

General Publications

• Pei X, Zhou W, Wang GD, Cai XH, Zheng YF, Liu XM. Comparison of Three-Dimensional Navigation-Guided Percutaneous Iliosacral Screw and Minimally Invasive Percutaneous Plate for the Treatment of Zone II Unstable Sacral Fractures. Orthop Surg. 2023 Feb;15(2):471-9.
• Pishnamaz M, Dienstknecht T, Hoppe B, Garving C, Lange H, Hildebrand F, et al. Assessment of pelvic injuries treated with ilio-sacral screws: injury severity and accuracy of screw positioning. Int Orthop. 2016 Jul;40(7):1495-501.
• Berger-Groch J, Lueers M, Rueger JM, Lehmann W, Thiesen D, Kolb JP, et al. Accuracy of navigated and conventional iliosacral screw placement in B- and C-type pelvic ring fractures. Eur J Trauma Emerg Surg. 2020 Feb;46(1):107-13.
• Zarei M, Moosavi M, Saghebdoust S, Shafizadeh M, Rostami M. Percutaneous iliosacral screw insertion with only outlet and inlet fluoroscopic view for unstable pelvic ring injuries: Clinical and radiological outcomes. Surg Neurol Int. 2022;13:455.
• Qoreishy M, Movahedinia M, Maleki A, Kazemi S. Safe Corridor for Sacroiliac Screw Insertion Can Be Found Quickly Without the Use of the Lateral Sacral View. Arch Bone Jt Surg. 2022 Nov;10(11):959-63.
• Dehkhoda F, Manafi Rasi A, Zandi R, Abedi M, Ebadi SS. Percutaneous Sacroiliac Screw Fixation: A Modified Screw Insertion Method Using Just 2 Fluoroscopy Views. Arch Bone Jt Surg. 2024;12(8):574-9.
• Zwingmann J, Hauschild O, Bode G, Südkamp NP, Schmal H. Malposition and revision rates of different imaging modalities for percutaneous iliosacral screw fixation following pelvic fractures: a systematic review and meta-analysis. Arch Orthop Trauma Surg. 2013 Sep;133(9):1257-65.
• Hinsche AF, Giannoudis PV, Smith RM. Fluoroscopy-based multiplanar image guidance for insertion of sacroiliac screws. Clin Orthop Relat Res. 2002 Feb;(395):135-44.
• van den Bosch EW, van Zwienen CM, van Vugt AB. Fluoroscopic positioning of sacroiliac screws in 88 patients. J Trauma. 2002 Jul;53(1):44-8.
• Matta JM, Saucedo T. Internal fixation of pelvic ring fractures. Clin Orthop Relat Res. 1989 May;(242):83-97
• Michela F, Capasso L, Olivi A, Vitiello C, Leone A, Liuzza F. 3D - Navigated percutaneous screw fixation of pelvic ring injuries - a pilot study. Injury. 2020 Aug 1;51:S28-33.
• Kim CH, Kim JJ, Kim JW. Percutaneous posterior transiliac plate versus iliosacral screw fixation for posterior fixation of Tile C-type pelvic fractures: a retrospective comparative study. BMC Musculoskeletal Disorders. 2022 Jun 16;23(1).
• Kaiser SP, Gardner MJ, Liu J, Routt MLC, Morshed S. Anatomic Determinants of Sacral Dysmorphism and Implications for Safe Iliosacral Screw Placement. Journal of Bone and Joint Surgery. 2014 Jul 16;96(14):e120
• Tabaie SA, Bledsoe JG, Moed BR. Biomechanical Comparison of Standard Iliosacral Screw Fixation to Transsacral Locked Screw Fixation in a Type C Zone II Pelvic Fracture Model. Journal of Orthopaedic Trauma. 2013 Sep;27(9):521-6.
• Liu F, Yu J, Yang H, Cai L, Chen L, Lei Q, et al. Iliosacral screw fixation of pelvic ring disruption with tridimensional patient-specific template guidance. Orthopaedics & Traumatology Surgery & Research. 2022 Apr 1;108(2):103210-0

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Actual): April 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Orthopedic trauma; Pelvic injury; Sacral fracture; Fluoroscopic view; Percutaneous SI screw
• Other Study ID Numbers: ChonburiH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No