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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06440590
Enrollment
30
Registered
2024-06-04
Start date
2023-04-01
Completion date
2024-08-20
Last updated
2024-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

PROCEDUREsuprapectineal quadrilateral buttress plating

15 cases will undergo anatomical supra-pectineal quadrilateral plate

PROCEDUREInfra-pectineal plating

15 cases will undergo conventional manually contoured infra-pectineal plate

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

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.

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

Eligibility

Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of Excellent, very good, Good, Average or Poor functional outcomes using Modified Merle d'Aubigné scoring systemone-year post-operativeClinical 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)
Rate of Anatomical, Congruent or Incongruent Radiological Outcomes using Matta & Tornetta radiological principles1 year postoperativeRadiological 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.
Amount of residual displacementimmediate post-operative and throughout study completionResidual displacement was measured in millimeters and compared between the two study groups

Secondary

MeasureTime frameDescription
post-operative complications' rate1-year post-operativeThe 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
Mean intraoperative blood lossup to 4 days post-operativeThe mean blood loss was calculated and compared between the two study groups, it was measured intraoperative and postoperative from suction drains
Mean operative timeit was calculated intra-operativeThe mean operation time was calculated in minutes and compared between the two study groups

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026