Supra-Pectineal QLS Plating Vs Infra-pectineal Plating in Management of Quadrilateral Plate Fractures

Not Applicable

Active, not recruiting

• Conditions: Evaluation of QL Buttress Plating in QLP Fracture Fixation
• Interventions: Procedure: Infra-pectineal plating; Procedure: suprapectineal quadrilateral buttress plating

• Registration Number: NCT06440590
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2023-04-01
• Study First Submitted: 2024-05-26
• Study First Submitted QC: 2024-06-03
• Study First Posted: 2024-06-04
• Status Verified: 2024-07
• Primary Completion: 2024-07-10
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30
• Study Completion: 2024-08-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infrapectineal plating	Infra-pectineal plating	Patients treated by infra-pectineal conventional plating applied on the medial wall through anterior intrapelvic approach
supra-pectineal quadrilateral buttress plating	suprapectineal quadrilateral buttress plating	Patients treated by supra-pectineal quadrilateral buttress plating through anterior intrapelvic approach

Primary Outcome Measures

Name	Time	Method
Rate of Excellent, very good, Good, Average or Poor functional outcomes using Modified Merle d'Aubigné scoring system	one-year post-operative	Clinical assessment was done via Modified Merle d'Aubigné scoring system that was calculated at each follow-up visit (out of 18) and presented the mean value; the score evaluates three factors: pain, mobility \& ability to walk. the score maximum being 18 (excellent) and minimum 6 (poor)
Amount of residual displacement	immediate post-operative and throughout study completion	Residual displacement was measured in millimeters and compared between the two study groups
Rate of Anatomical, Congruent or Incongruent Radiological Outcomes using Matta & Tornetta radiological principles	1 year postoperative	Radiological assesment was done according to the grading of Matta and Tornetta, The investigators classified the results into: Anatomical, congruent \& incongruent; based on the restoration of the five anatomical lines (iliopectineal line, ilioischial line, acetabular dome, posterior wall \& anterior wall) \& best judged on the anteroposterior view.

Secondary Outcome Measures

Name	Time	Method
Mean intraoperative blood loss	up to 4 days post-operative	The mean blood loss was calculated and compared between the two study groups, it was measured intraoperative and postoperative from suction drains
Mean operative time	it was calculated intra-operative	The mean operation time was calculated in minutes and compared between the two study groups
post-operative complications' rate	1-year post-operative	The investigators focused the evaluation of Postoperative complications on the local complications related to fixation principles and technique: LLD, AVN of the hip joint, wound infection, residual malunion or non-union of the quadrilateral plate, and loss of reduction

Trial Locations

Locations (1)

Ain Shams university; 🇪🇬 Cairo, Abassia, Egypt