Acetabulum FractureNCT06634251
Antegrade Screw Placement Technique in Anterior Column of Acetabulum
An observational study of Acetabulum Fracture, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
This retrospective observational study aims to define the optimal antegrade entry point for screw placement in the anterior column fixation corridor (ACFC) of the acetabulum. Using fluoroscopic visualization techniques, the study examines computed tomography (CT) scans from 500 healthy adult patients to simulate screw… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acetabulum Fracture
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 1 Aug 2024
- Phase
- Observational
- 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 65 years
- All sexes
- Adult, Older adult
Study population: The study population consists of 500 healthy adults, including 250 males and 250 females, aged between 18 and 65 years. Participants were selected based on their pelvic computed tomography (CT) scans, which displayed complete and fully matured pelvic anatomy. Individuals with prior orthopedic surgeries, pelvic fractures, deformities, or any bone pathologies such as rheumatologic diseases, advanced osteoporosis, and bone metastasis were excluded. The study focuses on assessing anatomical parameters and optimal entry points for anterior column fixation using fluoroscopic guidance.
Who may be able to join
- Patients with pelvic computed tomography (CT) scans that provide complete anatomical details of the pelvis.
- Patients aged 18 to 65 years.
- Patients with fully matured bone structures, without evidence of fractures, deformities, or prior orthopedic surgery.
- Patients with no history of rheumatologic disease, advanced osteoporosis, bone metastasis, or metabolic bone disorders.
Who cannot join
- Patients with pelvic CT scans that do not fully display the anatomical structures.
- Patients younger than 18 years or older than 65 years.
- Patients with pelvic fractures, deformities, or prior orthopedic surgeries.
- Patients with incomplete clinical or radiological data.
- Patients with rheumatologic sequelae, bone metastasis, or metabolic bone diseases.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakırköy Dr. Sadi Konuk Education and Research Hospital, Department of Orthopedics and Traumatology
Istanbul
About this study
Official title: Defining Fluoroscopic Visualization Technique for Optimal Antegrade Entry Point and Anatomical Parameters in Anterior Column Fixation Corridor for Pelvic Surgery: A Novel Perspective
This retrospective observational study aims to define the optimal antegrade entry point for screw placement in the anterior column fixation corridor (ACFC) of the acetabulum. Using fluoroscopic visualization techniques, the study examines computed tomography (CT) scans from 500 healthy adult patients to simulate screw placement and measure anatomical parameters. The goal is to determine patient-specific entry points and to assess the feasibility of screw placement using axial fluoroscopic views. The study also investigates gender-specific anatomical variations to provide insights for safer and more precise screw placement during anterior column fixation in pelvic surgery.
Read the detailed description
This study focuses on developing and validating a fluoroscopic visualization technique for identifying the optimal antegrade entry point (OAEP) in the anterior column fixation corridor (ACFC) of the acetabulum during pelvic surgery. Using three-dimensional reconstructions from pelvic computed tomography (CT) data of 500 healthy adults, the study simulates screw placement within the ACFC. A cylinder representing the screw is inserted virtually through the OAEP, ensuring that it remains within the confines of the fixation corridor without breaching its boundaries. The study records anatomical measurements, including the corridor's diameter, length, and the angles required for sagittal and coronal plane inclinations to visualize the OAEP.
The study also examines gender-specific anatomical variations, including differences in ACFC diameter, length, and required fluoroscopic angles. By defining patient-specific entry points and establishing a reliable fluoroscopic technique, this study aims to provide a practical and accessible method for anterior column fixation, minimizing complications and improving the safety and precision of screw placement in pelvic surgeries.
This novel approach has the potential to offer a cost-effective alternative to more expensive navigation systems, making it widely applicable in clinical settings.
- Conditions
- Acetabulum Fracture
- Being tested
- No intervention
- Keywords
- acetabulum fracture, virtual study, anterior column
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This study is purely observational and does not involve any direct intervention. It utilizes retrospective analysis of computed tomography (CT) scans to simulate the fluoroscopic visualization and screw placement technique in the anterior column fixation corridor (ACFC) of the acetabulum. The objective is to define the optimal antegrade entry point and assess anatomical parameters without performing any physical intervention on the participants.
| Study group | Role | What they receive |
|---|---|---|
| male group | This group consists of 250 healthy male adults whose pelvic CT scans were analyzed to define the optimal antegrade entry point and anatomical parameters for anterior column fixation. The fluoroscopic visualization technique and screw placement were simulated to assess anatomical variations and feasibility specific to the male cohort. Receives: Other: No intervention | |
| female group | This group consists of 250 healthy female adults whose pelvic CT scans were analyzed to define the optimal antegrade entry point and anatomical parameters for anterior column fixation. The fluoroscopic visualization technique and screw placement were simulated to assess anatomical variations and feasibility specific to the female cohort. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial Visualization Success
Success in obtaining axial fluoroscopic visualization of the anterior column fixation corridor (ACFC) and optimal antegrade entry point (OAEP).
Measured: During the simulation of the fluoroscopic imaging, typically within 1 hour of starting the procedure.
Screw Placement Feasibility
Feasibility of virtual screw placement within the ACFC without breaching the corridor boundaries.
Measured: During the simulation of the screw placement, typically within 1 hour of starting the procedure.
Secondary outcomes (4)
ACFC Diameter (ACFC-R)
Measurement of the ACFC diameter in millimeters (R) to assess screw placement feasibility.
Measured: During the simulation of the screw placement, typically within 1 hour of starting the procedure.
ACFC Length (ACFC-L)
Measurement of the ACFC length in millimeters (L) to assess screw placement feasibility.
Measured: During the simulation of the screw placement, typically within 1 hour of starting the procedure.
Sagittal Plane Inclination (SPI)
Measurement of the sagittal plane inclination (SPI) required for optimal fluoroscopic visualization of the ACFC.
Measured: During the simulation of the screw placement, typically within 1 hour of starting the procedure.
Coronal Plane Inclination (CPI)
Measurement of the coronal plane inclination (CPI) required for optimal fluoroscopic visualization of the ACFC.
Measured: During the simulation of the screw placement, typically within 1 hour of starting the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start1 Jun 2024
- Primary completion1 Jul 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acetabulum FractureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Vedat Öztürk, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634251
- Sponsor's protocol ID
- 2024/45-2024-04-01
- Status last verified
- Oct 2024
- First submitted
- 8 Oct 2024
- Last updated
- 9 Oct 2024
- Results posted
- 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 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Fluoroscopic Visualization Technique for Optimal Antegrade Entry Point and Anatomical Parameters in Anterior Column Fixation Corridor for Pelvic Surgery: A Novel Perspective
- ClinicalTrials.gov ID
- NCT06634251
- Acronym / sponsor ID
- 2024/45-2024-04-01
- Conditions
- Acetabulum Fracture
- Keywords
- acetabulum fracture, virtual study, anterior column
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 9 Oct 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.
This retrospective observational study aims to define the optimal antegrade entry point for screw placement in the anterior column fixation corridor (ACFC) of the acetabulum. Using fluoroscopic visualization techniques, the study examines computed tomography (CT) scans from 500 healthy adult patients to simulate screw placement and measure anatomical parameters. The goal is to determine patient-specific entry points and to assess the feasibility of screw placement using axial fluoroscopic views. The study also investigates gender-specific anatomical variations to provide insights for safer and more precise screw placement during anterior column fixation in pelvic surgery.
Detailed description
This study focuses on developing and validating a fluoroscopic visualization technique for identifying the optimal antegrade entry point (OAEP) in the anterior column fixation corridor (ACFC) of the acetabulum during pelvic surgery. Using three-dimensional reconstructions from pelvic computed tomography (CT) data of 500 healthy adults, the study simulates screw placement within the ACFC. A cylinder representing the screw is inserted virtually through the OAEP, ensuring that it remains within the confines of the fixation corridor without breaching its boundaries. The study records anatomical measurements, including the corridor's diameter, length, and the angles required for sagittal and coronal plane inclinations to visualize the OAEP.
The study also examines gender-specific anatomical variations, including differences in ACFC diameter, length, and required fluoroscopic angles. By defining patient-specific entry points and establishing a reliable fluoroscopic technique, this study aims to provide a practical and accessible method for anterior column fixation, minimizing complications and improving the safety and precision of screw placement in pelvic surgeries.
This novel approach has the potential to offer a cost-effective alternative to more expensive navigation systems, making it widely applicable in clinical settings.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| male group | – | Other: No interventionThis group consists of 250 healthy male adults whose pelvic CT scans were analyzed to define the optimal antegrade entry point and anatomical parameters for anterior column fixation. The fluoroscopic visualization technique and screw placement were simulated to assess anatomical variations and feasibility specific to the male cohort. |
| female group | – | Other: No interventionThis group consists of 250 healthy female adults whose pelvic CT scans were analyzed to define the optimal antegrade entry point and anatomical parameters for anterior column fixation. The fluoroscopic visualization technique and screw placement were simulated to assess anatomical variations and feasibility specific to the female cohort. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population consists of 500 healthy adults, including 250 males and 250 females, aged between 18 and 65 years. Participants were selected based on their pelvic computed tomography (CT) scans, which displayed complete and fully matured pelvic anatomy. Individuals with prior orthopedic surgeries, pelvic fractures, deformities, or any bone pathologies such as rheumatologic diseases, advanced osteoporosis, and bone metastasis were excluded. The study focuses on assessing anatomical parameters and optimal entry points for anterior column fixation using fluoroscopic guidance.
Key inclusion criteria (4 listed)
- Patients with pelvic computed tomography (CT) scans that provide complete anatomical details of the pelvis.
- Patients aged 18 to 65 years.
- Patients with fully matured bone structures, without evidence of fractures, deformities, or prior orthopedic surgery.
- Patients with no history of rheumatologic disease, advanced osteoporosis, bone metastasis, or metabolic bone disorders.
Key exclusion criteria (5 listed)
- Patients with pelvic CT scans that do not fully display the anatomical structures.
- Patients younger than 18 years or older than 65 years.
- Patients with pelvic fractures, deformities, or prior orthopedic surgeries.
- Patients with incomplete clinical or radiological data.
- Patients with rheumatologic sequelae, bone metastasis, or metabolic bone diseases.
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 |
|---|---|---|
| No interventionThis study is purely observational and does not involve any direct intervention. It utilizes retrospective analysis of computed tomography (CT) scans to simulate the fluoroscopic visualization and screw placement technique in the anterior column fixation corridor (ACFC) of the acetabulum. The objective is to define the optimal antegrade entry point and assess anatomical parameters without performing any physical intervention on the participants. | Other | female group, male group |
Primary outcome
Axial Visualization Success
Time frame: During the simulation of the fluoroscopic imaging, typically within 1 hour of starting the procedure.
Success in obtaining axial fluoroscopic visualization of the anterior column fixation corridor (ACFC) and optimal antegrade entry point (OAEP).
Screw Placement Feasibility
Time frame: During the simulation of the screw placement, typically within 1 hour of starting the procedure.
Feasibility of virtual screw placement within the ACFC without breaching the corridor boundaries.
4 secondary outcomes
ACFC Diameter (ACFC-R)
Time frame: During the simulation of the screw placement, typically within 1 hour of starting the procedure.
ACFC Length (ACFC-L)
Time frame: During the simulation of the screw placement, typically within 1 hour of starting the procedure.
Sagittal Plane Inclination (SPI)
Time frame: During the simulation of the screw placement, typically within 1 hour of starting the procedure.
Coronal Plane Inclination (CPI)
Time frame: During the simulation of the screw placement, typically within 1 hour of starting the procedure.
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 9 Oct 2024.
- 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.
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?
An observational study of Acetabulum Fracture, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
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 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: finished, as of the sponsor's last update on 9 Oct 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 Turkey (Türkiye). 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?
Axial Visualization Success (time frame: During the simulation of the fluoroscopic imaging, typically within 1 hour of starting the procedure.). 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 9 Oct 2024.