Unstable Pelvic FracturesNCT05871866
The Use of a Minimally Invasive Internal Fixation Device for Treatment of Unstable Pelvic Ring Fractures
A study testing minimally invasive internal fixation device "infix" in people with Unstable Pelvic Fractures, run by Sohag University at 1 site in Egypt.
Trial summary
Pelvic fractures are common presentations to major trauma centers and are associated with significant morbidity in polytrauma patients. Traditional open reduction and internal fixation is associated with a high incidence of surgical morbidity, while external fixators, used for both temporary stabilisation and as… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Unstable Pelvic Fractures
- What is being tested?
- minimally invasive internal fixation device "infix"
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Jan 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
- No healthy volunteers
- Adult
Who may be able to join
- Patients who had APC-II
- Patients who had APC-III
- Patients who had LC - II
- Patients who had LC -III
Who cannot join
- Patients who had immature skeletons or medical contraindications such as combined neurovascular injuries and uncontrolled medical diseases.
- Open fractures.
- Stable pelvic ring fractures.
- Patients who had combined acetabular fractures
- Patients who had a hernia or previous lower abdominal surgery.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Elshazly s Mousa, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
magdy m Amin, professor
About this study
Pelvic fractures are common presentations to major trauma centers and are associated with significant morbidity in polytrauma patients. Traditional open reduction and internal fixation is associated with a high incidence of surgical morbidity, while external fixators, used for both temporary stabilisation and as definitive management, have a complication rate of up to 62% [4], with poor patient tolerance, pin site infection and aseptic loosening the more commonly documented complications in the literature.
Minimally invasive techniques have become more popular recently in the management of pelvic injuries due to their lower incidence of surgical morbidity. The application of a pelvic internal fixator (INFIX) has been presented as a comparable alternative to external fixation of anterior pelvic ring injuries.
- Conditions
- Unstable Pelvic Fractures
- Being tested
- minimally invasive internal fixation device "infix"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimally invasive internal fixation device "infix"Procedure or surgery
An INFIX involves the insertion of spinal pedicle screws in the anterior pelvis (supra-acetabular entry) and the placement of a connecting rod in the subcutaneous tissue of the patient
What is being measured
The primary outcome is the main question the study is designed to answer.
advantages using INFIX
good patient tolerance
Measured: 6 months
union
radiological
Measured: 1 yea
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start1 Jan 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Unstable Pelvic FracturesStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Essam Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871866
- Sponsor's protocol ID
- soh-Med-23-04-01MD
- Status last verified
- May 2023
- First submitted
- 15 May 2023
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Steer R, Balendra G, Matthews J, Wullschleger M, Reidy J. The use of anterior subcutaneous internal fixation (INFIX) for treatment of pelvic ring injuries in major trauma patients, complications and outcomes. SICOT J. 2019;5:22. doi: 10.1051/sicotj/2019019. Epub 2019 Jun 28.
PubMed 31250805Lee C, Sciadini M. The Use of External Fixation for the Management of the Unstable Anterior Pelvic Ring. J Orthop Trauma. 2018 Sep;32 Suppl 6:S14-S17. doi: 10.1097/BOT.0000000000001251.
PubMed 30095676Hoskins W, Bucknill A, Wong J, Britton E, Judson R, Gumm K, Santos R, Sheehy R, Griffin X. A prospective case series for a minimally invasive internal fixation device for anterior pelvic ring fractures. J Orthop Surg Res. 2016 Nov 8;11(1):135. doi: 10.1186/s13018-016-0468-9.
PubMed 27825365Muller FJ, Stosiek W, Zellner M, Neugebauer R, Fuchtmeier B. The anterior subcutaneous internal fixator (ASIF) for unstable pelvic ring fractures: clinical and radiological mid-term results. Int Orthop. 2013 Nov;37(11):2239-45. doi: 10.1007/s00264-013-2032-0. Epub 2013 Aug 31.
PubMed 23995332
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Minimally Invasive Internal Fixation Device for Treatment of Unstable Pelvic Ring Fractures
- ClinicalTrials.gov ID
- NCT05871866
- Acronym / sponsor ID
- soh-Med-23-04-01MD
- Conditions
- Unstable Pelvic Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 23 May 2023 (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.
Pelvic fractures are common presentations to major trauma centers and are associated with significant morbidity in polytrauma patients. Traditional open reduction and internal fixation is associated with a high incidence of surgical morbidity, while external fixators, used for both temporary stabilisation and as definitive management, have a complication rate of up to 62% [4], with poor patient tolerance, pin site infection and aseptic loosening the more commonly documented complications in the literature.
Minimally invasive techniques have become more popular recently in the management of pelvic injuries due to their lower incidence of surgical morbidity. The application of a pelvic internal fixator (INFIX) has been presented as a comparable alternative to external fixation of anterior pelvic ring injuries.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients who had APC-II
- Patients who had APC-III
- Patients who had LC - II
- Patients who had LC -III
Key exclusion criteria (6 listed)
- Patients who had immature skeletons or medical contraindications such as combined neurovascular injuries and uncontrolled medical diseases.
- Open fractures.
- Stable pelvic ring fractures.
- Patients who had combined acetabular fractures
- Patients who had a hernia or previous lower abdominal surgery.
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 |
|---|---|---|
| minimally invasive internal fixation device "infix"An INFIX involves the insertion of spinal pedicle screws in the anterior pelvis (supra-acetabular entry) and the placement of a connecting rod in the subcutaneous tissue of the patient | Procedure or surgery | – |
Primary outcome
advantages using INFIX
Time frame: 6 months
good patient tolerance
union
Time frame: 1 yea
radiological
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Background: PubMed 31250805Steer R, Balendra G, Matthews J, Wullschleger M, Reidy J. The use of anterior subcutaneous internal fixation (INFIX) for treatment of pelvic ring injuries in major trauma patients, complications and outcomes. SICOT J. 2019;5:22. doi: 10.1051/sicotj/2019019. Epub 2019 Jun 28.
- Background: PubMed 30095676Lee C, Sciadini M. The Use of External Fixation for the Management of the Unstable Anterior Pelvic Ring. J Orthop Trauma. 2018 Sep;32 Suppl 6:S14-S17. doi: 10.1097/BOT.0000000000001251.
- Background: PubMed 27825365Hoskins W, Bucknill A, Wong J, Britton E, Judson R, Gumm K, Santos R, Sheehy R, Griffin X. A prospective case series for a minimally invasive internal fixation device for anterior pelvic ring fractures. J Orthop Surg Res. 2016 Nov 8;11(1):135. doi: 10.1186/s13018-016-0468-9.
- Background: PubMed 23995332Muller FJ, Stosiek W, Zellner M, Neugebauer R, Fuchtmeier B. The anterior subcutaneous internal fixator (ASIF) for unstable pelvic ring fractures: clinical and radiological mid-term results. Int Orthop. 2013 Nov;37(11):2239-45. doi: 10.1007/s00264-013-2032-0. Epub 2013 Aug 31.
- 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. This study is not recruiting at the moment.
Elshazly s Mousa, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing minimally invasive internal fixation device "infix" in people with Unstable Pelvic Fractures, run by Sohag 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 4 inclusion and 6 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 23 May 2023. 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?
Contact mohamed E Ahmed, assistant lecteure (01007422680, mohamed.essam@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
advantages using INFIX (time frame: 6 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?
On the ClinicalTrials.gov record for NCT05871866, which also lists 4 linked publications.
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 23 May 2023.