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

NCT ID: NCT06792305

Last Updated: 2025-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pelvic Ring Fractures Pelvic Ring Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group A will be fixed anteriorly first

Group A will consist of 15 patients and will be fixed anteriorly first.

Group Type ACTIVE_COMPARATOR

Starting by anterior ring fixation in vertical shear pelvic ring injuries

Intervention Type 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.

Group B will be fixed posteriorly first

Group B: 15 cases, and will be fixed posteriorly first.

Group Type ACTIVE_COMPARATOR

Starting by posterior ring fixation in vertical shear pelvic ring injuries

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Karim Atef Salem

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ainshams University Hospitals

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Karim Salem, Masters of Orthopedic surgery

Role: CONTACT

1000017388 ext. +20

Facility Contacts

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Karim Salem, Master of Orthopedic surgery

Role: primary

1000017388 ext. +20

Other Identifiers

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No funds recieved

Identifier Type: OTHER

Identifier Source: secondary_id

FMASU R230/2024

Identifier Type: -

Identifier Source: org_study_id

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