NCT07571798

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2026

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

April 21, 2026

Last Update Submit

April 30, 2026

Conditions

High-energy TraumaSacral FracturesPosterior Pelvic Ring Injury

Keywords

Sacral fractureFluoroscopic viewOrthopedic traumaPercutaneous SI screwPelvic injury

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Radiation Exposure Time

    Perioperative record

  • Neurological complications by physical examinations and symptoms

    Immediate postoperative to two months after operation

  • Screw malposition

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

Study Arms (2)

Percutaneous SI screw insertion using two fluoroscopic views

ACTIVE COMPARATOR

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

Percutaneous SI screw insertion using three fluoroscopic views

ACTIVE COMPARATOR

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

Interventions

Percutaneous sacroiliac screw fixation using two or three fluoroscopic viewsPROCEDURE

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

Percutaneous SI screw insertion using three fluoroscopic viewsPercutaneous SI screw insertion using two fluoroscopic views

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonburi Hospital, 69 Moo 2 Sukhumvit Road

Chon Buri, Changwat Chon Buri, 20000, Thailand

Location

Related Publications (15)

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • Matta JM, Saucedo T. Internal fixation of pelvic ring fractures. Clin Orthop Relat Res. 1989 May;(242):83-97

    BACKGROUND

  • 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.

    BACKGROUND

  • 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).

    BACKGROUND

  • 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

    BACKGROUND

  • 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.

    BACKGROUND

  • 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

    BACKGROUND

Study Officials

  • Panachol Leangtanom

    Chonburi hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Paticipants will undergo the operation with only one technique (either two-view fluoroscopy or three-view fluoroscopy)
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2026

First Posted

May 6, 2026

Study Start

February 1, 2026

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

May 6, 2026

Record last verified: 2026-04

Locations

TH(1)