Trauma (Including Fractures)Phase 4InfrapectinealNCT07170280
Evaluation of Direct Infrapectineal Plating in Quadrilateral Plate Acetabular Fractures
A Phase 4 study testing Direct Infrapectineal Plating in Quadrilateral Plate Acetabular Fractures: A Prospective Cohort Study in people with Trauma (Including Fractures), run by Mahmoud Fahmy at 1 site in Egypt.
Trial summary
This study aims to evaluate the outcomes of direct infrapectineal plate fixation in patients with quadrilateral plate acetabular fractures. A total of 25 adult patients with acute fractures were enrolled between 2021 and 2024 at a university-affiliated hospital. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Trauma (Including Fractures)
- What is being tested?
- Direct Infrapectineal Plating in Quadrilateral Plate Acetabular Fractures: A Prospective Cohort Study
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Jan 2024
- Phase
- Phase 4
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Acute quadrilateral plate acetabular fractures (≤3 weeks from injury).
- Medically fit for surgery under general or regional anesthesia.
- Patients willing to participate and provide informed consent. -
- Exclusion Criteria:Pathological fractures (e.g., metastatic or metabolic).
- Pre-existing ipsilateral hip pathology affecting radiological or functional outcomes.
- Delayed presentation: injury >4 weeks before surgery.
Show all 9Show fewer
- Medical contraindications to surgery (e.g., unstable comorbidities).
- Polytrauma patients with hemodynamic instability.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiological and Functional Evaluation of Direct Infrapectineal Plating in Quadrilateral Plate Acetabular Fractures: A Prospective Cohort Study
This study aims to evaluate the outcomes of direct infrapectineal plate fixation in patients with quadrilateral plate acetabular fractures. A total of 25 adult patients with acute fractures were enrolled between 2021 and 2024 at a university-affiliated hospital. All patients underwent surgical fixation through the ilioinguinal approach. Radiological results were assessed using the Matta scoring system, and functional outcomes were evaluated using the Merle d'Aubigné and Postel scoring system. The study further assessed complication rates, operative time, intraoperative blood loss, and hospital stay.
Read the detailed description
Quadrilateral plate acetabular fractures are complex injuries that present challenges in achieving stable fixation due to their anatomical location and high risk of medial displacement. The direct infrapectineal plate, applied via the ilioinguinal approach, offers a biomechanically stable construct for buttressing the medial acetabular wall.
This prospective cohort study enrolled 25 patients aged 18-64 years with acute quadrilateral plate acetabular fractures between January 2021 and January 2024. Patients with pathological fractures, pre-existing ipsilateral hip disease, or delayed presentation (>4 weeks) were excluded.
The surgical procedure involved direct infrapectineal plating through the ilioinguinal approach. Radiological outcomes were measured using the Matta scoring system, and functional results were assessed with the Merle d'Aubigné and Postel scoring system at a mean follow-up of 14.7 months. Secondary measures included operative time, blood loss, hospital stay, and complication profile.
Preliminary results showed that anatomical reduction was achieved in 64% of patients, with excellent or good functional results in 68%. The complication rate was low, with only one case of deep infection requiring implant removal.
The study concludes that infrapectineal plating provides stable fixation with favorable functional and radiological outcomes for quadrilateral plate acetabular fractures.
- Conditions
- Trauma (Including Fractures)
- Being tested
- Direct Infrapectineal Plating in Quadrilateral Plate Acetabular Fractures: A Prospective Cohort Study
- Keywords
- Acetabular fracture, Surgical fixation, Quadrilateral plate, Ilioinguinal approach
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Infrapectineal Plating in Quadrilateral Plate Acetabular Fractures: A Prospective Cohort StudyProcedure or surgery
This study aims to evaluate the outcomes of direct infrapectineal plate fixation in patients with quadrilateral plate acetabular fractures. A total of 25 adult patients with acute fractures were enrolled between 2021 and 2024 at a university-affiliated hospital. All patients underwent surgical fixation through the ilioinguinal approach. Radiological results were assessed using the Matta scoring system, and functional outcomes were evaluated using the Merle d'Aubigné and Postel scoring system. The study further assessed complication rates, operative time, intraoperative blood loss, and hospital stay.
| Study group | Role | What they receive |
|---|---|---|
| Radiological and Functional Evaluation of Direct Infrapectineal Plating in Quadrilateral Plate Aceta | Other | Quadrilateral plate acetabular fractures are complex injuries that present challenges in achieving stable fixation due to their anatomical location and high risk of medial displacement. The direct infrapectineal plate, applied via the ilioinguinal approach, offers a biomechanically stable construct for buttressing the medial acetabular wall.
This prospective cohort study enrolled 25 patients aged 18-64 years with acute quadrilateral plate acetabular fractures between January 2021 and January 2024. Patients with pathological fractures, pre-existing ipsilateral hip disease, or delayed presentation (>4 weeks) were excluded.
The surgical procedure involved direct infrapectineal plating through the ilioinguinal approach. Radiological outcomes were measured using the Matta scoring system, and functional results were assessed with the Merle d'Aubigné and Postel scoring system at a mean follow-up of 14.7 months. Secondary measures included operative time, blood loss, hospital stay, and comp Receives: Procedure: Direct Infrapectineal Plating in Quadrilateral Plate Acetabular Fractures: A Prospective Cohort Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological and Functional Evaluation of Direct Infrapectineal Plating in Quadrilateral Plate Acetabular Fractures: A Prospective Cohort Study
Primary Outcome Measures
Description: Radiographic assessment using the Matta scoring system at long-term follow-up.
Time Frame: monthly till 4 years postoperatively
Description: Postoperative anteroposterior and Judet pelvic radiographs assessed using the Matta scoring system. Reduction quality classified as anatomical (0-1 mm displacement), imperfect (2-3 mm), or poor (>3 mm).Radiological outcome at long-term follow-up
Unit of Measure: Number of patients per reduction category
Measured: 4 years
Secondary outcomes (1)
Radiological and Functional Evaluation of Direct Infrapectineal Plating in Quadrilateral Plate Acetabular Fractures: A Prospective Cohort Study
Functional outcome (Merle d'Aubigné and Postel scoring system)
Time Frame: monthly till 4 years postoperatively Description: Functional evaluation of hip pain, mobility, and walking ability using the Merle d'Aubigné and Postel scoring system. Outcomes categorized as excellent, good, fair, or poor.
Unit of Measure: Number of patients per functional category
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start1 Jan 2021
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
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 Trauma (Including Fractures)Studies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Quadrilateral plate acetabular fractures are complex injuries that present challenges in achieving stable fixation due to their anatomical location and high risk of medial displacement. The direct infrapectineal plate, applied via the ilioinguinal approach, offers a biomechanically stable construct for buttressing the medial acetabular wall. This prospective cohort study enrolled 25 patients aged 18-64 years with acute quadrilateral plate acetabular fractures between January 2021 and January 2024. Patients with pathological fractures, pre-existing ipsilateral hip disease, or delayed presentation (\>4 weeks) were excluded. The surgical procedure involved direct infrapectineal plating through the ilioinguinal approach. Radiological outcomes were measured using the Matta scoring system, and functional results were assessed with the Merle d'Aubigné and Postel scoring system at a mean follow-up of 14.7 months. Secondary measures included operative time, blood loss, hospital stay, and compl
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahmoud Fahmy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahmoud Fahmy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170280
- Sponsor's protocol ID
- MD-350-2021
- Acronym
- Infrapectineal
- Status last verified
- Sep 2025
- First submitted
- 29 Aug 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (e.g., baseline demographics, intraoperative details, postoperative outcomes, functional and radiological scores) that underlie the results reported in the publication will be shared. No direct identifiers will be included.
Publications
Fahmy M, Sadek FZ, Abdel Karim M, Fadel MH, Gobba M. Quadrilateral plate acetabular fractures: radiological and functional outcomes of direct infrapectineal plating. Int Orthop. 2026 Jul;50(7):1749-1757. doi: 10.1007/s00264-026-06882-4. Epub 2026 Jun 3.
PubMed 42234014
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiological and Functional Evaluation of Direct Infrapectineal Plating in Quadrilateral Plate Acetabular Fractures: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07170280
- Acronym / sponsor ID
- Infrapectineal / MD-350-2021
- Conditions
- Trauma (Including Fractures)
- Keywords
- Acetabular fracture, Surgical fixation, Quadrilateral plate, Ilioinguinal approach
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mahmoud FahmyUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 12 Sep 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.
This study aims to evaluate the outcomes of direct infrapectineal plate fixation in patients with quadrilateral plate acetabular fractures. A total of 25 adult patients with acute fractures were enrolled between 2021 and 2024 at a university-affiliated hospital. All patients underwent surgical fixation through the ilioinguinal approach. Radiological results were assessed using the Matta scoring system, and functional outcomes were evaluated using the Merle d'Aubigné and Postel scoring system. The study further assessed complication rates, operative time, intraoperative blood loss, and hospital stay.
Detailed description
Quadrilateral plate acetabular fractures are complex injuries that present challenges in achieving stable fixation due to their anatomical location and high risk of medial displacement. The direct infrapectineal plate, applied via the ilioinguinal approach, offers a biomechanically stable construct for buttressing the medial acetabular wall.
This prospective cohort study enrolled 25 patients aged 18-64 years with acute quadrilateral plate acetabular fractures between January 2021 and January 2024. Patients with pathological fractures, pre-existing ipsilateral hip disease, or delayed presentation (>4 weeks) were excluded.
The surgical procedure involved direct infrapectineal plating through the ilioinguinal approach. Radiological outcomes were measured using the Matta scoring system, and functional results were assessed with the Merle d'Aubigné and Postel scoring system at a mean follow-up of 14.7 months. Secondary measures included operative time, blood loss, hospital stay, and complication profile.
Preliminary results showed that anatomical reduction was achieved in 64% of patients, with excellent or good functional results in 68%. The complication rate was low, with only one case of deep infection requiring implant removal.
The study concludes that infrapectineal plating provides stable fixation with favorable functional and radiological outcomes for quadrilateral plate acetabular fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Quadrilateral plate acetabular fractures are complex injuries that present challenges in achieving stable fixation due to their anatomical location and high risk of medial displacement. The direct infrapectineal plate, applied via the ilioinguinal approach, offers a biomechanically stable construct for buttressing the medial acetabular wall. This prospective cohort study enrolled 25 patients aged 18-64 years with acute quadrilateral plate acetabular fractures between January 2021 and January 2024. Patients with pathological fractures, pre-existing ipsilateral hip disease, or delayed presentation (>4 weeks) were excluded. The surgical procedure involved direct infrapectineal plating through the ilioinguinal approach. Radiological outcomes were measured using the Matta scoring system, and functional results were assessed with the Merle d'Aubigné and Postel scoring system at a mean follow-up of 14.7 months. Secondary measures included operative time, blood loss, hospital stay, and compl
| Arm | Type | Receives |
|---|---|---|
| Radiological and Functional Evaluation of Direct Infrapectineal Plating in Quadrilateral Plate Aceta | Other | Procedure: Direct Infrapectineal Plating in Quadrilateral Plate Acetabular Fractures: A Prospective Cohort StudyQuadrilateral plate acetabular fractures are complex injuries that present challenges in achieving stable fixation due to their anatomical location and high risk of medial displacement. The direct infrapectineal plate, applied via the ilioinguinal approach, offers a biomechanically stable construct for buttressing the medial acetabular wall. This prospective cohort study enrolled 25 patients aged 18-64 years with acute quadrilateral plate acetabular fractures between January 2021 and January 2024. Patients with pathological fractures, pre-existing ipsilateral hip disease, or delayed presentation (>4 weeks) were excluded. The surgical procedure involved direct infrapectineal plating through the ilioinguinal approach. Radiological outcomes were measured using the Matta scoring system, and functional results were assessed with the Merle d'Aubigné and Postel scoring system at a mean follow-up of 14.7 months. Secondary measures included operative time, blood loss, hospital stay, and comp |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Acute quadrilateral plate acetabular fractures (≤3 weeks from injury).
- Medically fit for surgery under general or regional anesthesia.
- Patients willing to participate and provide informed consent. -
- Exclusion Criteria:Pathological fractures (e.g., metastatic or metabolic).
- Pre-existing ipsilateral hip pathology affecting radiological or functional outcomes.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Direct Infrapectineal Plating in Quadrilateral Plate Acetabular Fractures: A Prospective Cohort StudyThis study aims to evaluate the outcomes of direct infrapectineal plate fixation in patients with quadrilateral plate acetabular fractures. A total of 25 adult patients with acute fractures were enrolled between 2021 and 2024 at a university-affiliated hospital. All patients underwent surgical fixation through the ilioinguinal approach. Radiological results were assessed using the Matta scoring system, and functional outcomes were evaluated using the Merle d'Aubigné and Postel scoring system. The study further assessed complication rates, operative time, intraoperative blood loss, and hospital stay. | Procedure or surgery | Radiological and Functional Evaluation of Direct Infrapectineal Plating in Quadrilateral Plate Aceta |
Primary outcome
Radiological and Functional Evaluation of Direct Infrapectineal Plating in Quadrilateral Plate Acetabular Fractures: A Prospective Cohort Study
Time frame: 4 years
Primary Outcome Measures Description: Radiographic assessment using the Matta scoring system at long-term follow-up. Time Frame: monthly till 4 years postoperatively Description: Postoperative anteroposterior and Judet pelvic radiographs assessed using the Matta scoring system. Reduction quality classified as anatomical (0-1 mm displacement), imperfect (2-3 mm), or poor (>3 mm).Radiological outcome at long-term follow-up Unit of Measure: Number of patients per reduction category
1 secondary outcome
Radiological and Functional Evaluation of Direct Infrapectineal Plating in Quadrilateral Plate Acetabular Fractures: A Prospective Cohort Study
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Derived from this study: PubMed 42234014Fahmy M, Sadek FZ, Abdel Karim M, Fadel MH, Gobba M. Quadrilateral plate acetabular fractures: radiological and functional outcomes of direct infrapectineal plating. Int Orthop. 2026 Jul;50(7):1749-1757. doi: 10.1007/s00264-026-06882-4. Epub 2026 Jun 3.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (e.g., baseline demographics, intraoperative details, postoperative outcomes, functional and radiological scores) that underlie the results reported in the publication will be shared. No direct identifiers will be included.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Direct Infrapectineal Plating in Quadrilateral Plate Acetabular Fractures: A Prospective Cohort Study in people with Trauma (Including Fractures), run by Mahmoud Fahmy 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 9 inclusion and 0 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: finished, as of the sponsor's last update on 12 Sep 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Radiological and Functional Evaluation of Direct Infrapectineal Plating in Quadrilateral Plate Acetabular Fractures: A Prospective Cohort Study (time frame: 4 years). 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 NCT07170280, 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 12 Sep 2025.