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

N/AActive Not RecruitingNCT06439108

Ain Shams University30 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Evaluation of Single Symphyseal Plating in APC III Injuries

Interventions

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

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

Eligibility

Sex: ALLMin age: 16 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Islam Sayed Moussa

Cairo, Abassia, Egypt

Outcomes

Primary Outcomes

Rate of Excellent, Good, Fair or Poor clinical outcome

clinical assessment by Majeed pelvic scoring system evaluated and calculated at each follow-up visit with the mean value presented

Time frame: 1 year postoperative

Rate of Excellent, Good, Fair or Poor radiological outcome

Radiological assessment using Matta \& Tornetta radiological principles via plain x-ray pelvis showing both hips: anteroposterior, inlet and outlet views \& CT pelvis if available; we evaluated 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 and Tornetta, we classified the results into Excellent (less than or equal 4 mm), Good (4-10 mm), Fair (10-20 mm), and Poor (more than 20 mm).

Time frame: 1 year postoperative

Rate of recurrent diastasis

rate of symphyseal translation was measured \& compared between the two study groups

Time frame: throughout study completion, average one year postoperative

Secondary Outcomes

Mean intraoperative blood loss

The mean blood loss was calculated in milliliters and compared between the two study groups, it was measured intraoperative and postoperative from suction drains

Time frame: up to 5 days post-operative

Mean operative time

The mean operation time was calculated in minutes and compared between the two study groups

Time frame: It was calculated intra-operative

postoperative complications' rate

We focused the evaluation of Postoperative complications on the local complications related to fixation principles and technique: LLD, implant failure, wound infection, residual malunion or non-union of the anterior ring, and loss of reduction (2ry SI dislocation or any rotational or vertical re-displacement)

Data from ClinicalTrials.gov

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