Clinical trial NCT06440590: Supra-Pectineal QLS Plating Vs Infra-pectineal Plating in Management of Quadrilateral Plate Fractures
Official title: Supra-Pectineal Quadrilateral Buttress Plating Versus Infra-pectineal Plating in Management of Quadrilateral Plate Fractures: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Evaluation of QL Buttress Plating in QLP Fracture Fixation
Keywords: quadrilateral plate fractures
anterior column fractures
associated both column fractures
infra-pectineal plating
supra-pectineal quadrilateral buttress plating
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-06-04
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 quadrilateral plate fractures between February 2022 and June 2023 that met our inclusion criteria. The independent doctor allocated the 30 cases to two groups: Group A (15 cases): supra-pectineal quadrilateral buttress plating, group B (15 cases): Infra-pectineal plating
Primary purpose: TREATMENT

Brief summary: The investigators conducted such a prospective randomized controlled study aiming to reach a satisfactory outcome and to compare supra-pectineal QL buttress plating versus infra-pectineal for management of anterior column with or without posterior hemi-transverse component and quadrilateral plate involvement.

Detailed description: Our hypothesis was that supra-pectineal quadrilateral buttress plating provides much more rigid fixation and a strong buttress for medial wall migration, also it could correlate with a better functional and radiological outcome. However, there is a lack of knowledge in the prospective assessment of functional and radiological outcomes and follow up of postoperative complications of supra-pectineal quadrilateral buttress plating versus infra-pectineal plating in fixation of QLS and to our knowledge, it will be the first study to include such measures of outcome together in a prospective randomized fashion.

Eligibility criteria: Inclusion Criteria:

* Anterior column fracture acetabulum with QLS involvement
* Anterior column posterior hemi-transverse fracture acetabulum with QLS involvement
* Age between 16-60 years' old

Exclusion Criteria:

* Open fractures
* Associated pelvic ring injuries that require intervention
* Associated internal organ injuries that require intervention
* Age less than 14 years and older than 60 years

Primary outcomes:
measure: Rate of Excellent, very good, Good, Average or Poor functional outcomes using Modified Merle d'Aubigné scoring system
timeFrame: one-year post-operative
measure: Rate of Anatomical, Congruent or Incongruent Radiological Outcomes using Matta & Tornetta radiological principles
timeFrame: 1 year postoperative
measure: Amount of residual displacement
timeFrame: immediate post-operative and throughout study completion
Secondary outcomes:
measure: post-operative complications' rate
timeFrame: 1-year post-operative
measure: Mean intraoperative blood loss
timeFrame: up to 4 days post-operative
measure: Mean operative time
timeFrame: it was calculated intra-operative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams university
state: Abassia
Study officials:
affiliation: no funding recieved
name: Islam S Moussa, MD
role: STUDY_CHAIR
References: