Clinical trial NCT06439108: Single vs Double Symphyseal Plating in Management of Vertically Unstable Open Book Pelvic Ring Injuries:
Official title: Single Versus Double Symphyseal Plating in Management of Vertically Unstable Open Book Pelvic Ring Injuries: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Excellent, Good, Fair or Poor clinical outcome
timeFrame: 1 year postoperative
measure: Rate of Excellent, Good, Fair or Poor radiological outcome
timeFrame: 1 year postoperative
measure: Rate of recurrent diastasis
timeFrame: throughout study completion, average one year postoperative
Secondary outcomes:
measure: Mean intraoperative blood loss
timeFrame: up to 5 days post-operative
measure: Mean operative time
timeFrame: It was calculated intra-operative
measure: postoperative complications' rate
timeFrame: 1 year post-operative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Islam Sayed Moussa
state: Abassia
Study officials:
affiliation: no funding recieved
name: Islam S Moussa, MD
role: STUDY_CHAIR
References: