Single vs Double Symphyseal Plating in Management of Vertically Unstable Open Book Pelvic Ring Injuries:

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-07-15

Brief Summary

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compare functional, radiological outcomes, implant failure and the incidence of recurrent diastasis of single superior symphyseal plate versus double plating in management of vertically unstable open book injuries

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Detailed Description

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The real algorithm was the necessity for double superior \& anterior plating versus single superior symphyseal plate in management of APC III pelvic ring injuries, whether the incidence of intraoperative and short-term postoperative complications, recurrent diastasis, radiological and functional outcomes differed between these two methods. Our hypothesis was that the use of an additional anterior symphyseal plating could provide a more rigid fixation, with less complications of recurrent diastasis or implant failure. Also it will be applied through the same incision without increasing the patient overall morbidity.

Conditions

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Evaluation of Single Symphyseal Plating in APC III Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

An independent doctor created the randomization sequence using Excel 2016 (computerized random numbers) with a 1:1 allocation via random block sizes of 2, 4, and 6; he assigned the sample numbers equally to each group and assigned the block. Patients and physicians allocated to each intervention group were aware of the allocation; however, the data analysts and the outcome assessors were kept blinded to the allocation. The investigators prospectively carried out this study on 30 patients with APC III pelvic ring injuries between March 2022 and May 2023 that met our inclusion criteria. The independent doctor allocated the 30 cases to two groups: Group A (15 cases): single superior symphyseal plate, group B (15 cases): double superior \& anterior symphyseal plate

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Patients and physicians allocated to each intervention group were aware of the allocation; however, the data analysts and the outcome assessors were kept blinded to the allocation.

Study Groups

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single superior symphyseal plate

15 cases undergoing single superior symphyseal plate, reduction of the posterior ring was either closed reduction in SI joint dislocations \& fracture-dislocations and sacral fractures or open reduction in iliac wing fractures through the lateral window of the ilioinguinal approach.Anterior pelvic ring reduction and fixation was done via the classic Pfannenstiel approach

Group Type ACTIVE_COMPARATOR

single symphyseal plating in management of vertically unsable open book pelvic ring injuries

Intervention Type PROCEDURE

open book pelvic ring injuries can be managed via the two techniques.

double superior & anterior symphyseal plates

15 cases undergoing double superior \& anterior symphyseal plates, 15 cases undergoing double superior \& anterior symphyseal plates, reduction of the posterior ring was either closed reduction in SI joint dislocations \& fracture-dislocations and sacral fractures or open reduction in iliac wing fractures through the lateral window of the ilioinguinal approach.Anterior pelvic ring reduction and fixation was done via the classic Pfannenstiel approach

Group Type ACTIVE_COMPARATOR

single symphyseal plating in management of vertically unsable open book pelvic ring injuries

Intervention Type PROCEDURE

open book pelvic ring injuries can be managed via the two techniques.

Interventions

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single symphyseal plating in management of vertically unsable open book pelvic ring injuries

open book pelvic ring injuries can be managed via the two techniques.

Intervention Type PROCEDURE

Other Intervention Names

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double symphyseal plating in management of vertically unsable open book pelvic ring injuries

Eligibility Criteria

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Inclusion Criteria

* Anterior ring symphyses diastasis
* Tile C pelvic ring injuries
* Age between 16-60 years' old

Exclusion Criteria

* Tile B pelvic ring injuries
* Isolated bony fractures of the anterior pelvic ring
* Open fractures
* Age less than 14 years and older than 60 years
* Associated internal organ injuries that require definitive intervention

Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes