Evaluation of QL Buttress Plating in QLP Fracture FixationNCT06440590
Supra-Pectineal QLS Plating Vs Infra-pectineal Plating in Management of Quadrilateral Plate Fractures
A study testing suprapectineal quadrilateral buttress plating and Infra-pectineal plating in people with Evaluation of QL Buttress Plating in QLP Fracture Fixation, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Evaluation of QL Buttress Plating in QLP Fracture Fixation
- What is being tested?
- suprapectineal quadrilateral buttress plating and Infra-pectineal plating
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 20 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Anterior column fracture acetabulum with QLS involvement
- Anterior column posterior hemi-transverse fracture acetabulum with QLS involvement
- Age between 16-60 years' old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- suprapectineal quadrilateral buttress plating, Infra-pectineal plating
- Keywords
- quadrilateral plate fractures, anterior column fractures, associated both column fractures, infra-pectineal plating, supra-pectineal quadrilateral buttress plating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suprapectineal quadrilateral buttress platingProcedure or surgery
15 cases will undergo anatomical supra-pectineal quadrilateral plate
Infra-pectineal platingProcedure or surgery
15 cases will undergo conventional manually contoured infra-pectineal plate
| Study group | Role | What they receive |
|---|---|---|
| supra-pectineal quadrilateral buttress plating | Active comparator | Patients treated by supra-pectineal quadrilateral buttress plating through anterior intrapelvic approach Receives: Procedure: suprapectineal quadrilateral buttress plating |
| Infrapectineal plating | Active comparator | Patients treated by infra-pectineal conventional plating applied on the medial wall through anterior intrapelvic approach Receives: Procedure: Infra-pectineal plating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Excellent, very good, Good, Average or Poor functional outcomes using Modified Merle d'Aubigné scoring system
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)
Measured: one-year post-operative
Rate of Anatomical, Congruent or Incongruent Radiological Outcomes using Matta & Tornetta radiological principles
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.
Measured: 1 year postoperative
Amount of residual displacement
Residual displacement was measured in millimeters and compared between the two study groups
Measured: immediate post-operative and throughout study completion
Secondary outcomes (3)
post-operative complications' rate
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
Measured: 1-year post-operative
Mean intraoperative blood loss
The mean blood loss was calculated and compared between the two study groups, it was measured intraoperative and postoperative from suction drains
Measured: up to 4 days post-operative
Mean operative time
The mean operation time was calculated in minutes and compared between the two study groups
Measured: it was calculated intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Apr 2023
- Primary completion10 Jul 2024
- Study completion20 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluation of QL Buttress Plating in QLP Fracture FixationStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Moussa, Ain Shams University
- Investigators
- Islam S Moussa, MD, Study chair, no funding recieved
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440590
- Sponsor's protocol ID
- FMASU R66/2023
- Status last verified
- Jul 2024
- First submitted
- 26 May 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: i plan to share it with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supra-Pectineal Quadrilateral Buttress Plating Versus Infra-pectineal Plating in Management of Quadrilateral Plate Fractures: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06440590
- Acronym / sponsor ID
- FMASU R66/2023
- Keywords
- quadrilateral plate fractures, anterior column fractures, associated both column fractures, infra-pectineal plating, supra-pectineal quadrilateral buttress plating
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 20 Aug 2024 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| supra-pectineal quadrilateral buttress plating | Active comparator | Procedure: suprapectineal quadrilateral buttress platingPatients treated by supra-pectineal quadrilateral buttress plating through anterior intrapelvic approach |
| Infrapectineal plating | Active comparator | Procedure: Infra-pectineal platingPatients treated by infra-pectineal conventional plating applied on the medial wall through anterior intrapelvic approach |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Anterior column fracture acetabulum with QLS involvement
- Anterior column posterior hemi-transverse fracture acetabulum with QLS involvement
- Age between 16-60 years' old
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| suprapectineal quadrilateral buttress plating15 cases will undergo anatomical supra-pectineal quadrilateral plate | Procedure or surgery | supra-pectineal quadrilateral buttress plating |
| Infra-pectineal plating15 cases will undergo conventional manually contoured infra-pectineal plate | Procedure or surgery | Infrapectineal plating |
Primary outcome
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)
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.
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
3 secondary outcomes
post-operative complications' rate
Time frame: 1-year post-operative
Mean intraoperative blood loss
Time frame: up to 4 days post-operative
Mean operative time
Time frame: it was calculated intra-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: Yes. i plan to share it with other researchers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Islam S Moussa, MD study chair
no funding recieved
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing suprapectineal quadrilateral buttress plating and Infra-pectineal plating in people with Evaluation of QL Buttress Plating in QLP Fracture Fixation, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Excellent, very good, Good, Average or Poor functional outcomes using Modified Merle d'Aubigné scoring system (time frame: one-year post-operative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.