Acetabular FracturesNCT06347224
Both Column Fixation Corridor in Pelvic Surgery
A study testing Virtual placement of lag screws in both columns of the acetabulum on 3D pelvic CT models. in people with Acetabular Fractures, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
The concepts of the Both Column Fixation Corridor (BCFC) and Both Column Screws (BCS) have emerged as innovative approaches in orthopedic surgery yet have not been extensively explored in the literature. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acetabular Fractures
- What is being tested?
- Virtual placement of lag screws in both columns of the acetabulum on 3D pelvic CT models.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 1 Mar 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years.
- Both male and female participants.
- Participants with healthy pelvic anatomy as determined by CT imaging, without any previous fractures, deformities, or surgical interventions that could alter the pelvic structure.
Who cannot join
- History of pelvic or acetabular fractures.
- Previous pelvic surgeries that could alter the anatomical structure.
- Conditions significantly affecting bone quality, such as osteoporosis 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: Navigating the Both Column Fixation Corridor: Anatomical Insights From a Virtual Pelvic Screw Placement Study
The concepts of the Both Column Fixation Corridor (BCFC) and Both Column Screws (BCS) have emerged as innovative approaches in orthopedic surgery yet have not been extensively explored in the literature. This study aims to evaluate the feasibility and potential advantages of this novel screw fixation technique, thereby filling the existing gap in knowledge and establishing standards for its application.
Read the detailed description
Pelvic CT data will be collected from 400 healthy adults, including 200 males and 200 females. The Synapse software will be utilized to simulate the placement of both anterior and posterior Both Column Screws (BCS) in the Both Column Fixation Corridor (BCFC). Screws will be virtually implanted into the BCFC using the "Ozturk Procedure," a technique developed based on clinical practice. Measurements will include the thickness and length of each BCS for both anterior (aBCS) and posterior (pBCS) placements, as well as the distances from the screw centers to the spina iliaca anterior superior (SIAS). Additionally, the necessary caudo-cranial (CCT) and centro-lateral tilts (CLT) for achieving axial fluoroscopic visualization of the BCFC will be measured.
- Conditions
- Acetabular Fractures
- Being tested
- Virtual placement of lag screws in both columns of the acetabulum on 3D pelvic CT models.
- Keywords
- both column screw, percutaneous fixation, acetabulum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual placement of lag screws in both columns of the acetabulum on 3D pelvic CT models.Procedure or surgery
The intervention aims to simulate a percutaneous fixation technique that could be applied in a real surgical environment, offering insights into the potential for personalized surgical planning and optimization of outcomes for patients with acetabular fractures. This virtual approach allows for the exploration of various screw placement strategies without the ethical and practical constraints of direct clinical experimentation.
| Study group | Role | What they receive |
|---|---|---|
| male group | Other | Male Group: In this study, the male group consists of 200 healthy adult men selected from hospital radiology archive records, who have undergone pelvic computed tomography (CT) scans for various reasons. These individuals were chosen excluding those with pelvic fractures, anatomical abnormalities, or severe osteoporosis. The age range of the male group is between 18 and 65 years, with a median age of approximately 39.4 years. Analyses conducted on the male group focus on concepts such as the Both Column Fixation Corridor (BCFC) and Both Column Screws (BCS), evaluating the feasibility, gender-specific anatomical differences, and potential advantages of this new fixation technique. Receives: Procedure: Virtual placement of lag screws in both columns of the acetabulum on 3D pelvic CT models. |
| female group | Other | Female Group: Similarly, the female group comprises 200 healthy adult women who have had pelvic CT scans for any reason, selected from hospital radiology archives. Like the male group, these individuals meet the specific criteria set for the study. The age range for the female group is also between 18 and 65 years, with a median age comparable to that of the male group. The analysis of the female group centers on the feasibility of applying BCFC and BCS, taking into account the unique anatomical structures of the female pelvis and their implications for surgical planning. The work on this group aims to enhance the understanding of gender-specific anatomical variations and integrate this knowledge into surgical practices. Receives: Procedure: Virtual placement of lag screws in both columns of the acetabulum on 3D pelvic CT models. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Visualization of Both Column Fixation Corridor (BCFC) and Placement of Both Column Screws (BCS)
This measure evaluates whether the axial fluoroscopic image of the BCFC can be successfully demonstrated across all participant populations, regardless of gender, and whether it's feasible to place two BCS within the BCFC, one anterior and one posterior, in the surgical treatment of pelvic and acetabular fractures. It also examines gender-specific anatomical variations associated with the BCFC and BCS and their implications for surgical planning.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start1 Oct 2023
- Primary completion1 Feb 2024
- Study completion1 Mar 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 Acetabular FracturesStudies 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 N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 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
- Investigators
- Vedat Öztürk, Dr., Principal investigator, Bakırköy Dr. Sadi Konuk Education and Research Hospital, Department of Orthopedics and Traumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347224
- Sponsor's protocol ID
- BCFC-BCS-VIRTUAL2024
- Status last verified
- Apr 2024
- First submitted
- 29 Mar 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data (IPD) from this study is in place. Due to the sensitivity of the data and the need to protect participant confidentiality, these data will be accessible only to the research team and will not be shared with any third parties.
Publications
Ozturk V, Celik M, Koluman AC, Duramaz A, Kural C, Bilgili MG. Fluroscopy-assisted transiliac antegrade lag screw placement technique in both columns of acetabulum: A novel procedure. Orthop Traumatol Surg Res. 2024 Sep;110(5):103872. doi: 10.1016/j.otsr.2024.103872. Epub 2024 Mar 26.
PubMed 38548224
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Navigating the Both Column Fixation Corridor: Anatomical Insights From a Virtual Pelvic Screw Placement Study
- ClinicalTrials.gov ID
- NCT06347224
- Acronym / sponsor ID
- BCFC-BCS-VIRTUAL2024
- Conditions
- Acetabular Fractures
- Keywords
- both column screw, percutaneous fixation, acetabulum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 4 Apr 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.
The concepts of the Both Column Fixation Corridor (BCFC) and Both Column Screws (BCS) have emerged as innovative approaches in orthopedic surgery yet have not been extensively explored in the literature. This study aims to evaluate the feasibility and potential advantages of this novel screw fixation technique, thereby filling the existing gap in knowledge and establishing standards for its application.
Detailed description
Pelvic CT data will be collected from 400 healthy adults, including 200 males and 200 females. The Synapse software will be utilized to simulate the placement of both anterior and posterior Both Column Screws (BCS) in the Both Column Fixation Corridor (BCFC). Screws will be virtually implanted into the BCFC using the "Ozturk Procedure," a technique developed based on clinical practice. Measurements will include the thickness and length of each BCS for both anterior (aBCS) and posterior (pBCS) placements, as well as the distances from the screw centers to the spina iliaca anterior superior (SIAS). Additionally, the necessary caudo-cranial (CCT) and centro-lateral tilts (CLT) for achieving axial fluoroscopic visualization of the BCFC will be measured.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| male group | Other | Procedure: Virtual placement of lag screws in both columns of the acetabulum on 3D pelvic CT models.Male Group: In this study, the male group consists of 200 healthy adult men selected from hospital radiology archive records, who have undergone pelvic computed tomography (CT) scans for various reasons. These individuals were chosen excluding those with pelvic fractures, anatomical abnormalities, or severe osteoporosis. The age range of the male group is between 18 and 65 years, with a median age of approximately 39.4 years. Analyses conducted on the male group focus on concepts such as the Both Column Fixation Corridor (BCFC) and Both Column Screws (BCS), evaluating the feasibility, gender-specific anatomical differences, and potential advantages of this new fixation technique. |
| female group | Other | Procedure: Virtual placement of lag screws in both columns of the acetabulum on 3D pelvic CT models.Female Group: Similarly, the female group comprises 200 healthy adult women who have had pelvic CT scans for any reason, selected from hospital radiology archives. Like the male group, these individuals meet the specific criteria set for the study. The age range for the female group is also between 18 and 65 years, with a median age comparable to that of the male group. The analysis of the female group centers on the feasibility of applying BCFC and BCS, taking into account the unique anatomical structures of the female pelvis and their implications for surgical planning. The work on this group aims to enhance the understanding of gender-specific anatomical variations and integrate this knowledge into surgical practices. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 to 65 years.
- Both male and female participants.
- Participants with healthy pelvic anatomy as determined by CT imaging, without any previous fractures, deformities, or surgical interventions that could alter the pelvic structure.
Key exclusion criteria (3 listed)
- History of pelvic or acetabular fractures.
- Previous pelvic surgeries that could alter the anatomical structure.
- Conditions significantly affecting bone quality, such as osteoporosis 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 |
|---|---|---|
| Virtual placement of lag screws in both columns of the acetabulum on 3D pelvic CT models.The intervention aims to simulate a percutaneous fixation technique that could be applied in a real surgical environment, offering insights into the potential for personalized surgical planning and optimization of outcomes for patients with acetabular fractures. This virtual approach allows for the exploration of various screw placement strategies without the ethical and practical constraints of direct clinical experimentation. | Procedure or surgery | female group, male group |
Primary outcome
Successful Visualization of Both Column Fixation Corridor (BCFC) and Placement of Both Column Screws (BCS)
Time frame: up to 3 months
This measure evaluates whether the axial fluoroscopic image of the BCFC can be successfully demonstrated across all participant populations, regardless of gender, and whether it's feasible to place two BCS within the BCFC, one anterior and one posterior, in the surgical treatment of pelvic and acetabular fractures. It also examines gender-specific anatomical variations associated with the BCFC and BCS and their implications for surgical planning.
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 4 Apr 2024.
- Background: PubMed 38548224Ozturk V, Celik M, Koluman AC, Duramaz A, Kural C, Bilgili MG. Fluroscopy-assisted transiliac antegrade lag screw placement technique in both columns of acetabulum: A novel procedure. Orthop Traumatol Surg Res. 2024 Sep;110(5):103872. doi: 10.1016/j.otsr.2024.103872. Epub 2024 Mar 26.
- Individual participant dataSharing planned: No. No plan to share individual participant data (IPD) from this study is in place. Due to the sensitivity of the data and the need to protect participant confidentiality, these data will be accessible only to the research team and will not be shared with any third parties.
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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.
Vedat Öztürk, Dr. principal investigator
Bakırköy Dr. Sadi Konuk Education and Research Hospital, Department of Orthopedics and Traumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual placement of lag screws in both columns of the acetabulum on 3D pelvic CT models. in people with Acetabular Fractures, 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 3 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 4 Apr 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?
Successful Visualization of Both Column Fixation Corridor (BCFC) and Placement of Both Column Screws (BCS) (time frame: up to 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 NCT06347224, 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 4 Apr 2024.