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

Single Versus Double Symphyseal Plating in Management of Vertically Unstable Open Book Pelvic Ring Injuries: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06439108
Enrollment
30
Registered
2024-06-03
Start date
2023-04-01
Completion date
2024-07-15
Last updated
2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Evaluation of Single Symphyseal Plating in APC III Injuries

Keywords

APC III pelvic ring injuries, single symphyseal plating, double symphyseal plating, functional outcome, Majeed pelvic score

Brief summary

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

Detailed description

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.

Interventions

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

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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

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.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of Excellent, Good, Fair or Poor clinical outcome1 year postoperativeclinical assessment by Majeed pelvic scoring system evaluated and calculated at each follow-up visit with the mean value presented
Rate of Excellent, Good, Fair or Poor radiological outcome1 year postoperativeRadiological 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).
Rate of recurrent diastasisthroughout study completion, average one year postoperativerate of symphyseal translation was measured & compared between the two study groups

Secondary

MeasureTime frameDescription
Mean intraoperative blood lossup to 5 days post-operativeThe mean blood loss was calculated in milliliters and compared between the two study groups, it was measured intraoperative and postoperative from suction drains
Mean operative timeIt was calculated intra-operativeThe mean operation time was calculated in minutes and compared between the two study groups
postoperative complications' rate1 year post-operativeWe 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)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026