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

July 29, 2024 updated by: Islam Moussa, Ain Shams University

Supra-Pectineal Quadrilateral Buttress Plating Versus Infra-pectineal Plating in Management of Quadrilateral Plate Fractures: A Randomized Controlled Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Abassia
      • Cairo, Abassia, Egypt, 1234
        • Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: supra-pectineal quadrilateral buttress plating
Patients treated by supra-pectineal quadrilateral buttress plating through anterior intrapelvic approach
Procedure: suprapectineal quadrilateral buttress plating
15 cases will undergo anatomical supra-pectineal quadrilateral plate
Active Comparator: Infrapectineal plating
Patients treated by infra-pectineal conventional plating applied on the medial wall through anterior intrapelvic approach
Procedure: Infra-pectineal plating
15 cases will undergo conventional manually contoured infra-pectineal plate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Excellent, very good, Good, Average or Poor functional outcomes using Modified Merle d'Aubigné scoring system
Time Frame: 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)
one-year post-operative
Rate of Anatomical, Congruent or Incongruent Radiological Outcomes using Matta & Tornetta radiological principles
Time Frame: 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.
1 year postoperative
Amount of residual displacement
Time Frame: immediate post-operative and throughout study completion
Residual displacement was measured in millimeters and compared between the two study groups
immediate post-operative and throughout study completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post-operative complications' rate
Time Frame: 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
1-year post-operative
Mean intraoperative blood loss
Time Frame: 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
up to 4 days post-operative
Mean operative time
Time Frame: it was calculated intra-operative
The mean operation time was calculated in minutes and compared between the two study groups
it was calculated intra-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Chair: Islam S Moussa, MD, no funding recieved

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

July 10, 2024

Study Completion (Estimated)

August 20, 2024

Study Registration Dates

First Submitted

May 26, 2024

First Submitted That Met QC Criteria

June 3, 2024

First Posted (Actual)

June 4, 2024

Study Record Updates

Last Update Posted (Actual)

July 30, 2024

Last Update Submitted That Met QC Criteria

July 29, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU R66/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

i plan to share it with other researchers

IPD Sharing Time Frame

one year

IPD Sharing Access Criteria

full access

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe