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Recruiting Not applicable

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

NCT06792305 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2024-12-01
Last updated
2025-01-24

Condition(s) studied

Pelvic Ring FracturesPelvic Ring Injury

Investigational drug(s) / intervention(s)

Starting by anterior ring fixation in vertical shear pelvic ring injuriesStarting by posterior ring fixation in vertical shear pelvic ring injuries

Starting by anterior ring fixation in vertical shear pelvic ring injuries: 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: 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age: 18 years - 60 years. 2. Tile C1.2 and C1.3 pelvic ring injuries. 3. Pure anterior ring ligamentous injuries. Exclusion Criteria: 1. Bony fracture of the pubic rami. 2. Tile C2 and C3 pelvic ring injuries. 3. Associated acetabular fracture that requires intervention.

Primary outcome measure(s)

  • Radiological outcome scores — 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).
  • Clinical outcome score — 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.

Trial sites (1)

FacilityCityRegionStatus
Ainshams University Hospitals Cairo Egypt Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06792305 on ClinicalTrials.gov ↗ ← All trials in Egypt