Pelvic FractureNCT05354531
Outcome of the Anterior Subcutaneous Internal Fixator (INFIX) for Pelvic Ring Disruptions
A study testing anterior subcutaneous internal fixator ( INFIX) in people with Pelvic Fracture, run by Assiut University at 2 sites in Egypt.
Trial summary
With a prospective case series study of 15 patients The aim of this study is to estimate the clinical outcomes in patients with unstable anterior pelvic ring fractures ( B\&C ) after treatment with (INFIX) Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pelvic Fracture
- What is being tested?
- anterior subcutaneous internal fixator ( INFIX)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesEgypt
- Study dates
- 2 Mar 2022to 11 Mar 2025
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- skeletally mature patient.
- type B2 / B3 \& C1 pelvic fracture.
- open book B1 fracture with urogenital disruption.
- Patient with fatty tissue that cover pubic bones enable insertion of the rod.
- if there is a contraindication to Anterior symphyseal plating.
Who cannot join
- associated comorbidities preventing surgery.
- pelvic fracture associated with iliac bones fracture
- combined pelvis and acetabulum fracture.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Orthopedic and trauma department Assiut university
Asyut, 71511
Orthopedic and traumatology department Assiut university hospital
Asyut, 71511
About this study
With a prospective case series study of 15 patients The aim of this study is to estimate the clinical outcomes in patients with unstable anterior pelvic ring fractures ( B\&C ) after treatment with (INFIX)
Read the detailed description
Unstable pelvic ring fractures are usually associated with high energy trauma. They account for about 1.5-3.9% of all fractures, but they have a high rate of morbidity and mortality. Although the posterior pelvic ring provides the main stability (60%), the anterior ring still account for 40% of stability fracture pelvis B \&C according to tiles classification require fixation of the anterior ring or anterior-posterior ring simultaneously.
The external fixator is the most widely used treatment for initial and temporary stabilization of anterior pelvic ring injury, especially in emergency situations. It can be quickly placed and can easily stabilize the disrupted pelvic ring and decrease pelvic cavity haemorrhage. However, many clinical complications associated with the external fixator have been reported, including wound infection, loosening of the fixator, and impingement on the skin.
Moreover, the anterior pelvic external fixator limits patients' daily activities, such as sitting, lying in the lateral position, rolling over, and sexual intercourse
Recently, anterior subcutaneous internal fixator (INFIX) was proposed by several scholars to treat anterior pelvic ring injury.
INFIX was invented based upon the same biomechanical principle as the traditional external fixator, but it is placed subcutaneously. It proved to be stiffer than the traditional external fixator, and at the same time eliminates the open pin tracts, which increased the infection rate and nursing care .
INFIX was initially designed as an alternative to the external fixator, but recently its indications have been expanded and multiple complications have been reported.
- Conditions
- Pelvic Fracture
- Being tested
- anterior subcutaneous internal fixator ( INFIX)
- Keywords
- pelvic ring fractures, INFIX
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterior subcutaneous internal fixator ( INFIX)Procedure or surgery
INFIX was invented based upon the same biomechanical principle as the traditional external fixator, but it is placed subcutaneously. It proved to be stiffer than the traditional external fixator, and at the same time eliminates the open pin tracts, which increased the infection rate and nursing care
| Study group | Role | What they receive |
|---|---|---|
| INFIX group | Experimental | Those group of cases will be managed by INFIX for their pelvic ring disruption Receives: Procedure: anterior subcutaneous internal fixator ( INFIX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Majeed score
Majeed rating scale will be used to evaluate the functional outcome. Patients will be followed up by phone or at the clinic. functional recovery will be scored by asking the rating scale questions. These questions including the subjective feelings of pain, return to the work, the feelings of sitting, sexual intercourse, standing, walking distance, and the condition of gait. The aggregate score will be classified as excellent (>85), good (70-84), fair (55-69), or poor (<55).
Measured: After 3 months
Secondary outcomes (4)
Time to surgery
We will assess the time taken for the patient to be in the operation
Measured: Within the first week
Radiology dose
Sum of radiology dose taken intraoperatively
Measured: Within the first week
Procedure time
Time taken intraoperatively
Measured: Within the first week
Incidence and rate of adverse events
Any complications or problems should be assessed
Measured: After 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start2 Mar 2022
- Primary completion11 Mar 2025
- Study completion11 Mar 2025
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 Pelvic FractureStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One group of 20 cases should be managed by INFIX for their pelvic ring disruption
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyrillos Talaat saadallah abdelshahid, Assiut University
- Investigators
- Osama Farouk, Prof, Study chair, Orthopedic surgery department ,Assiut university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354531
- Sponsor's protocol ID
- INFIX
- Status last verified
- May 2025
- First submitted
- 1 Mar 2022
- Last updated
- 30 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Merriman DJ, Ricci WM, McAndrew CM, Gardner MJ. Is application of an internal anterior pelvic fixator anatomically feasible? Clin Orthop Relat Res. 2012 Aug;470(8):2111-5. doi: 10.1007/s11999-012-2287-6.
PubMed 22383020
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of the Anterior Subcutaneous Internal Fixator (INFIX) for Pelvic Ring Disruptions
- ClinicalTrials.gov ID
- NCT05354531
- Acronym / sponsor ID
- INFIX
- Conditions
- Pelvic Fracture
- Keywords
- pelvic ring fractures, INFIX
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 11 Mar 2025 (actual)
- Study completion
- 11 Mar 2025 (actual)
- First posted
- 29 Apr 2022 (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.
With a prospective case series study of 15 patients The aim of this study is to estimate the clinical outcomes in patients with unstable anterior pelvic ring fractures ( B\&C ) after treatment with (INFIX)
Detailed description
Unstable pelvic ring fractures are usually associated with high energy trauma. They account for about 1.5-3.9% of all fractures, but they have a high rate of morbidity and mortality. Although the posterior pelvic ring provides the main stability (60%), the anterior ring still account for 40% of stability fracture pelvis B \&C according to tiles classification require fixation of the anterior ring or anterior-posterior ring simultaneously.
The external fixator is the most widely used treatment for initial and temporary stabilization of anterior pelvic ring injury, especially in emergency situations. It can be quickly placed and can easily stabilize the disrupted pelvic ring and decrease pelvic cavity haemorrhage. However, many clinical complications associated with the external fixator have been reported, including wound infection, loosening of the fixator, and impingement on the skin.
Moreover, the anterior pelvic external fixator limits patients' daily activities, such as sitting, lying in the lateral position, rolling over, and sexual intercourse
Recently, anterior subcutaneous internal fixator (INFIX) was proposed by several scholars to treat anterior pelvic ring injury.
INFIX was invented based upon the same biomechanical principle as the traditional external fixator, but it is placed subcutaneously. It proved to be stiffer than the traditional external fixator, and at the same time eliminates the open pin tracts, which increased the infection rate and nursing care .
INFIX was initially designed as an alternative to the external fixator, but recently its indications have been expanded and multiple complications have been reported.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One group of 20 cases should be managed by INFIX for their pelvic ring disruption
| Arm | Type | Receives |
|---|---|---|
| INFIX group | Experimental | Procedure: anterior subcutaneous internal fixator ( INFIX)Those group of cases will be managed by INFIX for their pelvic ring disruption |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- skeletally mature patient.
- type B2 / B3 \& C1 pelvic fracture.
- open book B1 fracture with urogenital disruption.
- Patient with fatty tissue that cover pubic bones enable insertion of the rod.
- if there is a contraindication to Anterior symphyseal plating.
Key exclusion criteria (3 listed)
- associated comorbidities preventing surgery.
- pelvic fracture associated with iliac bones fracture
- combined pelvis and acetabulum fracture.
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 |
|---|---|---|
| anterior subcutaneous internal fixator ( INFIX)INFIX was invented based upon the same biomechanical principle as the traditional external fixator, but it is placed subcutaneously. It proved to be stiffer than the traditional external fixator, and at the same time eliminates the open pin tracts, which increased the infection rate and nursing care | Procedure or surgery | INFIX group |
Primary outcome
Majeed score
Time frame: After 3 months
Majeed rating scale will be used to evaluate the functional outcome. Patients will be followed up by phone or at the clinic. functional recovery will be scored by asking the rating scale questions. These questions including the subjective feelings of pain, return to the work, the feelings of sitting, sexual intercourse, standing, walking distance, and the condition of gait. The aggregate score will be classified as excellent (>85), good (70-84), fair (55-69), or poor (<55).
4 secondary outcomes
Time to surgery
Time frame: Within the first week
Radiology dose
Time frame: Within the first week
Procedure time
Time frame: Within the first week
Incidence and rate of adverse events
Time frame: After 6 months
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 30 May 2025.
- Background: PubMed 22383020Merriman DJ, Ricci WM, McAndrew CM, Gardner MJ. Is application of an internal anterior pelvic fixator anatomically feasible? Clin Orthop Relat Res. 2012 Aug;470(8):2111-5. doi: 10.1007/s11999-012-2287-6.
- Individual participant dataSharing planned: No
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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.
Osama Farouk, Prof study chair
Orthopedic surgery department ,Assiut university
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anterior subcutaneous internal fixator ( INFIX) in people with Pelvic Fracture, run by Assiut University at 2 sites 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 5 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: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Majeed score (time frame: After 3 months). 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 NCT05354531, 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 30 May 2025.