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

• 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

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