Pelvic Ring FracturesNCT06792305
The Sequence of Fixation in Tile C1.2 and C1.3 Vertical Shear Pelvic Ring Injuries.
A study testing Starting by anterior ring fixation in vertical shear pelvic ring injuries and Starting by posterior ring fixation in vertical shear pelvic ring injuries in people with Pelvic Ring Fractures and Pelvic Ring Injury, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this study is to compare the sequence of fixation in Vertically Unstable Tile C1.2 and C1.3 pelvic ring injuries, as regards clinical, radiological outcomes and implant failure rates. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pelvic Ring Fractures, Pelvic Ring Injury
- What is being tested?
- Starting by anterior ring fixation in vertical shear pelvic ring injuries and Starting by posterior ring fixation in vertical shear pelvic ring injuries
- 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 Dec 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18 years - 60 years.
- Tile C1.2 and C1.3 pelvic ring injuries.
- Pure anterior ring ligamentous injuries.
Who cannot join
- Bony fracture of the pubic rami.
- Tile C2 and C3 pelvic ring injuries.
- Associated acetabular fracture that requires intervention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ainshams University Hospitals
Cairo
Karim Salem, Master of Orthopedic surgery, 1000017388 ext. +20, karimatefsalem@gmail.com
Karim Salem, Masters of Orthopedic surgery
About this study
Official title: SEQUENCE OF FIXATION IN VERTICALLY UNSTABLE TILE C1.2 AND C1.3 PELVIC RING INJURIES: A PROSPECTIVE COMPARATIVE STUDY
The goal of this study is to compare the sequence of fixation in Vertically Unstable Tile C1.2 and C1.3 pelvic ring injuries, as regards clinical, radiological outcomes and implant failure rates. Our hypothesis is that starting with anterior ring fixation will achieve superior results as regards easier reduction, less operation time, and finally better radiological and functional outcomes when compared with starting with posterior ring fixation.
- Conditions
- Pelvic Ring Fractures, Pelvic Ring Injury
- Being tested
- Starting by anterior ring fixation in vertical shear pelvic ring injuries, Starting by posterior ring fixation in vertical shear pelvic ring injuries
- Keywords
- pelvic ring injuries, vertical shear pelvic fracture, tile classification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Starting by anterior ring fixation in vertical shear pelvic ring injuriesProcedure or surgery
The procedure will involve addressing the pelvic ring anteriorly with open reduction and internal fixation (ORIF) of the pubic rami and symphysis pubis by using a single 3.5 mm recon plate. The goal isto achieve anatomical reduction and stable fixation to restore the integrity of the pelvic ring. Fixation of the posterior ring will be achieved using a single sacroiliac screw in S1. The goal of posterior fixation is to achieve stability and alignment of the posterior pelvic structures.
Starting by posterior ring fixation in vertical shear pelvic ring injuriesProcedure or surgery
the procedure will involve fixation of the posterior ring which will be achieved by using a single sacroiliac screw in S1. Then open reduction and internal fixation (ORIF) of the pubic rami and symphysis pubis by using a single 3.5 mm recon plate.
| Study group | Role | What they receive |
|---|---|---|
| Group A will be fixed anteriorly first | Active comparator | Group A will consist of 15 patients and will be fixed anteriorly first. Receives: Procedure: Starting by anterior ring fixation in vertical shear pelvic ring injuries |
| Group B will be fixed posteriorly first | Active comparator | Group B: 15 cases, and will be fixed posteriorly first. Receives: Procedure: Starting by posterior ring fixation in vertical shear pelvic ring injuries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological outcome scores
Patients will be followed up at two weeks, six weeks, three months, six months and one year postoperatively. Matta \& Tornetta radiological principles will be used to assess the radiological and clinical outcomes via plain X-ray of pelvis showing both hips through anteroposterior, inlet and outlet views. Evaluation of five criteria on X-ray films postoperatively: residual posterior displacement, vertical displacement, pubic symphyseal translation, sagittal rotation and gapping of the sacroiliac joint. According to the grading of Matta \& Tornetta principles, results will be as follows; excellent (< 4 mm), good (4 - 10 mm), fair (10- 20 mm), and poor (> 20 mm).
Measured: 12 months
Clinical outcome score
Clinical outcome assessment at final follow up using Majeed pelvic score. Five factors are assessed and scored: pain, standing, sitting, sexual intercourse and work performance. The total score is then given a clinical grade as excellent, good, fair or poor.
Measured: 12 months
Secondary outcomes (2)
Operative time in minutes.
Operative time will be recorded in each group
Measured: 3 hours
Implant failure rate
Implant failure if any, will be recorded during follow up.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start1 Dec 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Ring FracturesStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karim Atef Salem, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792305
- Sponsor's protocol ID
- FMASU R230/2024
- Other IDs
- No funds recieved
- Status last verified
- Nov 2024
- First submitted
- 23 Nov 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEQUENCE OF FIXATION IN VERTICALLY UNSTABLE TILE C1.2 AND C1.3 PELVIC RING INJURIES: A PROSPECTIVE COMPARATIVE STUDY
- ClinicalTrials.gov ID
- NCT06792305
- Acronym / sponsor ID
- FMASU R230/2024
- Conditions
- Pelvic Ring Fractures, Pelvic Ring Injury
- Keywords
- pelvic ring injuries, vertical shear pelvic fracture, tile classification
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 24 Jan 2025 (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 goal of this study is to compare the sequence of fixation in Vertically Unstable Tile C1.2 and C1.3 pelvic ring injuries, as regards clinical, radiological outcomes and implant failure rates. Our hypothesis is that starting with anterior ring fixation will achieve superior results as regards easier reduction, less operation time, and finally better radiological and functional outcomes when compared with starting with posterior ring fixation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A will be fixed anteriorly first | Active comparator | Procedure: Starting by anterior ring fixation in vertical shear pelvic ring injuriesGroup A will consist of 15 patients and will be fixed anteriorly first. |
| Group B will be fixed posteriorly first | Active comparator | Procedure: Starting by posterior ring fixation in vertical shear pelvic ring injuriesGroup B: 15 cases, and will be fixed posteriorly first. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: 18 years - 60 years.
- Tile C1.2 and C1.3 pelvic ring injuries.
- Pure anterior ring ligamentous injuries.
Key exclusion criteria (3 listed)
- Bony fracture of the pubic rami.
- Tile C2 and C3 pelvic ring injuries.
- Associated acetabular fracture that requires intervention.
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 |
|---|---|---|
| Starting by anterior ring fixation in vertical shear pelvic ring injuriesThe procedure will involve addressing the pelvic ring anteriorly with open reduction and internal fixation (ORIF) of the pubic rami and symphysis pubis by using a single 3.5 mm recon plate. The goal isto achieve anatomical reduction and stable fixation to restore the integrity of the pelvic ring. Fixation of the posterior ring will be achieved using a single sacroiliac screw in S1. The goal of posterior fixation is to achieve stability and alignment of the posterior pelvic structures. | Procedure or surgery | Group A will be fixed anteriorly first |
| Starting by posterior ring fixation in vertical shear pelvic ring injuriesthe procedure will involve fixation of the posterior ring which will be achieved by using a single sacroiliac screw in S1. Then open reduction and internal fixation (ORIF) of the pubic rami and symphysis pubis by using a single 3.5 mm recon plate. | Procedure or surgery | Group B will be fixed posteriorly first |
Primary outcome
Radiological outcome scores
Time frame: 12 months
Patients will be followed up at two weeks, six weeks, three months, six months and one year postoperatively. Matta \& Tornetta radiological principles will be used to assess the radiological and clinical outcomes via plain X-ray of pelvis showing both hips through anteroposterior, inlet and outlet views. Evaluation of five criteria on X-ray films postoperatively: residual posterior displacement, vertical displacement, pubic symphyseal translation, sagittal rotation and gapping of the sacroiliac joint. According to the grading of Matta \& Tornetta principles, results will be as follows; excellent (< 4 mm), good (4 - 10 mm), fair (10- 20 mm), and poor (> 20 mm).
Clinical outcome score
Time frame: 12 months
Clinical outcome assessment at final follow up using Majeed pelvic score. Five factors are assessed and scored: pain, standing, sitting, sexual intercourse and work performance. The total score is then given a clinical grade as excellent, good, fair or poor.
2 secondary outcomes
Operative time in minutes.
Time frame: 3 hours
Implant failure rate
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Starting by anterior ring fixation in vertical shear pelvic ring injuries and Starting by posterior ring fixation in vertical shear pelvic ring injuries in people with Pelvic Ring Fractures and Pelvic Ring Injury, 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 3 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: looking for participants now, as of the sponsor's last update on 24 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karim Salem, Masters of Orthopedic surgery (1000017388 ext. +20, karimatefsalem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological outcome scores (time frame: 12 months). The study lists 2 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 24 Jan 2025.