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

SEQUENCE of FIXATION in VERTICALLY UNSTABLE TILE C1.2 and C1.3 PELVIC RING INJURIES: a PROSPECTIVE COMPARATIVE STUDY

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.

Study Overview

• Status: Recruiting
• Conditions: Pelvic Ring Injury; Pelvic Ring Fractures
• Intervention / Treatment: Procedure: Starting by anterior ring fixation in vertical shear pelvic ring injuries; Procedure: Starting by posterior ring fixation in vertical shear pelvic ring injuries

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karim Salem, Masters of Orthopedic surgery; Phone Number: +20 1000017388; Email: karimatefsalem@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Ainshams university hospitals
    • Contact: Karim Salem, Master of Orthopedic surgery; Phone Number: +20 1000017388; Email: karimatefsalem@gmail.com
    • Contact: Karim Salem, Masters of Orthopedic surgery

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A will be fixed anteriorly first; Group A will consist of 15 patients and will be fixed anteriorly first.	Procedure: 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.
Active Comparator: Group B will be fixed posteriorly first; Group B: 15 cases, and will be fixed posteriorly first.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiological outcome scores	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).	12 months
Clinical outcome score	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time in minutes.	Operative time will be recorded in each group	3 hours
Implant failure rate	Implant failure if any, will be recorded during follow up.	12 months

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 23, 2024
• First Submitted That Met QC Criteria: January 23, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 23, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: pelvic ring injuries; vertical shear pelvic fracture; tile classification
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: FMASU R230/2024; No funds recieved (Other Identifier: Ainshams University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No