Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06792305

The Sequence of Fixation in Tile C1.2 and C1.3 Vertical Shear Pelvic Ring Injuries.

The goal of this study is to compare the sequence of fixation in Vertically Unstable Tile C1.2 and C1.3 pelvic ring injuries, as regards clinical, radiological outcomes and implant failure rates. Our hypothesis is that starting with anterior ring fixation will achieve superior results as regards easier reduction, less operation time, and finally better radiological and functional outcomes when compared with starting with posterior ring fixation.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Pelvic Ring Fractures Pelvic Ring Injury

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ainshams University Hospitals

Cairo, Egypt

Location status: Recruiting

Location contact

Karim Salem, Master of Orthopedic surgery

CONTACT

[email protected]

1000017388 ext. +20

Karim Salem, Masters of Orthopedic surgery

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age: 18 years - 60 years.
  • Tile C1.2 and C1.3 pelvic ring injuries.
  • Pure anterior ring ligamentous injuries.

Exclusion criteria

  • Bony fracture of the pubic rami.
  • Tile C2 and C3 pelvic ring injuries.
  • Associated acetabular fracture that requires intervention.

Treatment and study plan

Starting by anterior ring fixation in vertical shear pelvic ring injuries

Procedure

The procedure will involve addressing the pelvic ring anteriorly with open reduction and internal fixation (ORIF) of the pubic rami and symphysis pubis by using a single 3.5 mm recon plate. The goal isto achieve anatomical reduction and stable fixation to restore the integrity of the pelvic ring. Fixation of the posterior ring will be achieved using a single sacroiliac screw in S1. The goal of posterior fixation is to achieve stability and alignment of the posterior pelvic structures.

Starting by posterior ring fixation in vertical shear pelvic ring injuries

Procedure

the procedure will involve fixation of the posterior ring which will be achieved by using a single sacroiliac screw in S1. Then open reduction and internal fixation (ORIF) of the pubic rami and symphysis pubis by using a single 3.5 mm recon plate.

Primary outcomes

  1. Radiological outcome scores

    Time frame: 12 months

    Patients will be followed up at two weeks, six weeks, three months, six months and one year postoperatively. Matta & Tornetta radiological principles will be used to assess the radiological and clinical outcomes via plain X-ray of pelvis showing both hips through anteroposterior, inlet and outlet views. Evaluation of five criteria on X-ray films postoperatively: residual posterior displacement, vertical displacement, pubic symphyseal translation, sagittal rotation and gapping of the sacroiliac joint. According to the grading of Matta & Tornetta principles, results will be as follows; excellent (< 4 mm), good (4 - 10 mm), fair (10- 20 mm), and poor (> 20 mm).

  2. Clinical outcome score

    Time frame: 12 months

    Clinical outcome assessment at final follow up using Majeed pelvic score. Five factors are assessed and scored: pain, standing, sitting, sexual intercourse and work performance. The total score is then given a clinical grade as excellent, good, fair or poor.

Secondary outcomes

  1. Operative time in minutes.

    Time frame: 3 hours

    Operative time will be recorded in each group

  2. Implant failure rate

    Time frame: 12 months

    Implant failure if any, will be recorded during follow up.

Study contacts

Contact information is provided by the study sponsor or research team.

Karim Salem, Masters of Orthopedic surgery

CONTACT

[email protected]

1000017388 ext. +20

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

SEQUENCE OF FIXATION IN VERTICALLY UNSTABLE TILE C1.2 AND C1.3 PELVIC RING INJURIES: A PROSPECTIVE COMPARATIVE STUDY

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 24, 2025
Registry last updated
Jan 24, 2025

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.