Evaluation of Single Symphyseal Plating in APC III InjuriesNCT06439108
Single vs Double Symphyseal Plating in Management of Vertically Unstable Open Book Pelvic Ring Injuries:
A study testing single symphyseal plating in management of vertically unsable open book pelvic ring injuries in people with Evaluation of Single Symphyseal Plating in APC III Injuries, run by Ain Shams University at 1 site in Egypt.
Trial summary
compare functional, radiological outcomes, implant failure and the incidence of recurrent diastasis of single superior symphyseal plate versus double plating in management of vertically unstable open book injuries 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 Single Symphyseal Plating in APC III Injuries
- What is being tested?
- single symphyseal plating in management of vertically unsable open book 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 Apr 2023to 15 Jul 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 ring symphyses diastasis
- Tile C pelvic ring injuries
- Age between 16-60 years' old
Who cannot join
- Tile B pelvic ring injuries
- Isolated bony fractures of the anterior pelvic ring
- Open fractures
- Age less than 14 years and older than 60 years
- Associated internal organ injuries that require definitive intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Versus Double Symphyseal Plating in Management of Vertically Unstable Open Book Pelvic Ring Injuries: A Randomized Controlled Trial
compare functional, radiological outcomes, implant failure and the incidence of recurrent diastasis of single superior symphyseal plate versus double plating in management of vertically unstable open book injuries
Read the detailed description
The real algorithm was the necessity for double superior \& anterior plating versus single superior symphyseal plate in management of APC III pelvic ring injuries, whether the incidence of intraoperative and short-term postoperative complications, recurrent diastasis, radiological and functional outcomes differed between these two methods. Our hypothesis was that the use of an additional anterior symphyseal plating could provide a more rigid fixation, with less complications of recurrent diastasis or implant failure. Also it will be applied through the same incision without increasing the patient overall morbidity.
- Being tested
- single symphyseal plating in management of vertically unsable open book pelvic ring injuries
- Keywords
- APC III pelvic ring injuries, single symphyseal plating, double symphyseal plating, functional outcome, Majeed pelvic score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single symphyseal plating in management of vertically unsable open book pelvic ring injuriesProcedure or surgery
Also called double symphyseal plating in management of vertically unsable open book pelvic ring injuries
open book pelvic ring injuries can be managed via the two techniques.
| Study group | Role | What they receive |
|---|---|---|
| single superior symphyseal plate | Active comparator | 15 cases undergoing single superior symphyseal plate, reduction of the posterior ring was either closed reduction in SI joint dislocations \& fracture-dislocations and sacral fractures or open reduction in iliac wing fractures through the lateral window of the ilioinguinal approach.Anterior pelvic ring reduction and fixation was done via the classic Pfannenstiel approach Receives: Procedure: single symphyseal plating in management of vertically unsable open book pelvic ring injuries |
| double superior & anterior symphyseal plates | Active comparator | 15 cases undergoing double superior \& anterior symphyseal plates, 15 cases undergoing double superior \& anterior symphyseal plates, reduction of the posterior ring was either closed reduction in SI joint dislocations \& fracture-dislocations and sacral fractures or open reduction in iliac wing fractures through the lateral window of the ilioinguinal approach.Anterior pelvic ring reduction and fixation was done via the classic Pfannenstiel approach Receives: Procedure: single symphyseal plating in management of vertically unsable open book pelvic ring injuries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Excellent, Good, Fair or Poor clinical outcome
clinical assessment by Majeed pelvic scoring system evaluated and calculated at each follow-up visit with the mean value presented
Measured: 1 year postoperative
Rate of Excellent, Good, Fair or Poor radiological outcome
Radiological assessment using Matta \& Tornetta radiological principles via plain x-ray pelvis showing both hips: anteroposterior, inlet and outlet views \& CT pelvis if available; we evaluated 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 and Tornetta, we classified the results into Excellent (less than or equal 4 mm), Good (4-10 mm), Fair (10-20 mm), and Poor (more than 20 mm).
Measured: 1 year postoperative
Rate of recurrent diastasis
rate of symphyseal translation was measured \& compared between the two study groups
Measured: throughout study completion, average one year postoperative
Secondary outcomes (3)
Mean intraoperative blood loss
The mean blood loss was calculated in milliliters and compared between the two study groups, it was measured intraoperative and postoperative from suction drains
Measured: up to 5 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
postoperative complications' rate
We focused the evaluation of Postoperative complications on the local complications related to fixation principles and technique: LLD, implant failure, wound infection, residual malunion or non-union of the anterior ring, and loss of reduction (2ry SI dislocation or any rotational or vertical re-displacement)
Measured: 1 year post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start1 Apr 2023
- Primary completion15 Apr 2024
- Study completion15 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Evaluation of Single Symphyseal Plating in APC III InjuriesStudies 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 APC III pelvic ring injuries between March 2022 and May 2023 that met our inclusion criteria. The independent doctor allocated the 30 cases to two groups: Group A (15 cases): single superior symphyseal plate, group B (15 cases): double superior \& anterior symphyseal plate
- Masking
- Double blind
- Who is masked
- Investigator, 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
- NCT06439108
- Sponsor's protocol ID
- FMASU R65/2023
- Status last verified
- May 2024
- First submitted
- 26 May 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: share the plan
Publications
Moussa IS, Abdelmonem IM, Nagy AM. Single versus double symphyseal plating in management of tile C1-2 and C1-3 pelvic ring injuries: a randomized controlled trial. BMC Surg. 2025 May 9;25(1):200. doi: 10.1186/s12893-025-02936-3.
PubMed 40346505
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Versus Double Symphyseal Plating in Management of Vertically Unstable Open Book Pelvic Ring Injuries: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06439108
- Acronym / sponsor ID
- FMASU R65/2023
- Keywords
- APC III pelvic ring injuries, single symphyseal plating, double symphyseal plating, functional outcome, Majeed pelvic score
- 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
- 15 Apr 2024 (actual)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 3 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.
compare functional, radiological outcomes, implant failure and the incidence of recurrent diastasis of single superior symphyseal plate versus double plating in management of vertically unstable open book injuries
Detailed description
The real algorithm was the necessity for double superior \& anterior plating versus single superior symphyseal plate in management of APC III pelvic ring injuries, whether the incidence of intraoperative and short-term postoperative complications, recurrent diastasis, radiological and functional outcomes differed between these two methods. Our hypothesis was that the use of an additional anterior symphyseal plating could provide a more rigid fixation, with less complications of recurrent diastasis or implant failure. Also it will be applied through the same incision without increasing the patient overall morbidity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, 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 APC III pelvic ring injuries between March 2022 and May 2023 that met our inclusion criteria. The independent doctor allocated the 30 cases to two groups: Group A (15 cases): single superior symphyseal plate, group B (15 cases): double superior \& anterior symphyseal plate
| Arm | Type | Receives |
|---|---|---|
| single superior symphyseal plate | Active comparator | Procedure: single symphyseal plating in management of vertically unsable open book pelvic ring injuries15 cases undergoing single superior symphyseal plate, reduction of the posterior ring was either closed reduction in SI joint dislocations \& fracture-dislocations and sacral fractures or open reduction in iliac wing fractures through the lateral window of the ilioinguinal approach.Anterior pelvic ring reduction and fixation was done via the classic Pfannenstiel approach |
| double superior & anterior symphyseal plates | Active comparator | Procedure: single symphyseal plating in management of vertically unsable open book pelvic ring injuries15 cases undergoing double superior \& anterior symphyseal plates, 15 cases undergoing double superior \& anterior symphyseal plates, reduction of the posterior ring was either closed reduction in SI joint dislocations \& fracture-dislocations and sacral fractures or open reduction in iliac wing fractures through the lateral window of the ilioinguinal approach.Anterior pelvic ring reduction and fixation was done via the classic Pfannenstiel approach |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Anterior ring symphyses diastasis
- Tile C pelvic ring injuries
- Age between 16-60 years' old
Key exclusion criteria (5 listed)
- Tile B pelvic ring injuries
- Isolated bony fractures of the anterior pelvic ring
- Open fractures
- Age less than 14 years and older than 60 years
- Associated internal organ injuries that require definitive 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 |
|---|---|---|
| single symphyseal plating in management of vertically unsable open book pelvic ring injuriesAlso: double symphyseal plating in management of vertically unsable open book pelvic ring injuriesopen book pelvic ring injuries can be managed via the two techniques. | Procedure or surgery | double superior & anterior symphyseal plates, single superior symphyseal plate |
Primary outcome
Rate of Excellent, Good, Fair or Poor clinical outcome
Time frame: 1 year postoperative
clinical assessment by Majeed pelvic scoring system evaluated and calculated at each follow-up visit with the mean value presented
Rate of Excellent, Good, Fair or Poor radiological outcome
Time frame: 1 year postoperative
Radiological assessment using Matta \& Tornetta radiological principles via plain x-ray pelvis showing both hips: anteroposterior, inlet and outlet views \& CT pelvis if available; we evaluated 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 and Tornetta, we classified the results into Excellent (less than or equal 4 mm), Good (4-10 mm), Fair (10-20 mm), and Poor (more than 20 mm).
Rate of recurrent diastasis
Time frame: throughout study completion, average one year postoperative
rate of symphyseal translation was measured \& compared between the two study groups
3 secondary outcomes
Mean intraoperative blood loss
Time frame: up to 5 days post-operative
Mean operative time
Time frame: It was calculated intra-operative
postoperative complications' rate
Time frame: 1 year post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Derived from this study: PubMed 40346505Moussa IS, Abdelmonem IM, Nagy AM. Single versus double symphyseal plating in management of tile C1-2 and C1-3 pelvic ring injuries: a randomized controlled trial. BMC Surg. 2025 May 9;25(1):200. doi: 10.1186/s12893-025-02936-3.
- Individual participant dataSharing planned: Yes. share the plan
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 single symphyseal plating in management of vertically unsable open book pelvic ring injuries in people with Evaluation of Single Symphyseal Plating in APC III Injuries, 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 5 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 3 Jun 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, Good, Fair or Poor clinical outcome (time frame: 1 year postoperative). 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?
On the ClinicalTrials.gov record for NCT06439108, which also lists 1 linked publication.
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 3 Jun 2024.