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

NCT ID: NCT06440590

Last Updated: 2024-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-08-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Evaluation of QL Buttress Plating in QLP Fracture Fixation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Double (Investigator, Outcomes Assessor) 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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

supra-pectineal quadrilateral buttress plating

Patients treated by supra-pectineal quadrilateral buttress plating through anterior intrapelvic approach

Group Type ACTIVE_COMPARATOR

suprapectineal quadrilateral buttress plating

Intervention Type PROCEDURE

15 cases will undergo anatomical supra-pectineal quadrilateral plate

Infrapectineal plating

Patients treated by infra-pectineal conventional plating applied on the medial wall through anterior intrapelvic approach

Group Type ACTIVE_COMPARATOR

Infra-pectineal plating

Intervention Type PROCEDURE

15 cases will undergo conventional manually contoured infra-pectineal plate

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

suprapectineal quadrilateral buttress plating

15 cases will undergo anatomical supra-pectineal quadrilateral plate

Intervention Type PROCEDURE

Infra-pectineal plating

15 cases will undergo conventional manually contoured infra-pectineal plate

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Islam Moussa

lecturer of orthopedic surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Islam S Moussa, MD

Role: STUDY_CHAIR

no funding recieved

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ain Shams university

Cairo, Abassia, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FMASU R66/2023

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Posterior Column Fractures of Tibial Plateau
NCT06931366 NOT_YET_RECRUITING
Open Reduction in Femoral Neck Fractures
NCT06872970 ACTIVE_NOT_RECRUITING NA
Fixation of Fracture Neck of Femur in Children
NCT06267885 NOT_YET_RECRUITING NA