Acetabular FractureCASEARFNCT06238804
Characteristic Analysis and Surgical Exploration for Acetabular Roof Fractures: Multicenter Retrospective Cohort Study
An observational study of Acetabular Fracture, run by Hebei Medical University Third Hospital at 1 site in China.
Trial summary
Acetabular roof was a crucial structure for maintaining the stability of hip joint; however, its important role was not especially emphasized in the Letournel-Judet classification system. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acetabular Fracture
- What is being tested?
- KL, Iliofemoral, Ilioinguinal, Iliac fossa and combined approaches
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 May 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 80 years
- All sexes
- Adult, Older adult
Study population: Patients met the inclusion criteria were collected in this study.
Who may be able to join
- 18-80 years, acute (<14 days) closed roof column/wall acetabular fractures (A3.1, A3.2 or A3.3) in Three-column classification, normal activity of the affected hip before the injury, received surgical reduction and internal fixation
Who cannot join
- open fractures, pathologic fractures, limited range of motion (ROM) of the hip joint before the injury, conservative treatment, risk factors affecting bone healing (such as smoking and metabolic diseases) and noncompletion of the two-year follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Acetabular roof was a crucial structure for maintaining the stability of hip joint; however, its important role was not especially emphasized in the Letournel-Judet classification system. Acetabular roof was segmented into the roof column and roof wall in Three-column classification and fracture in this area alone was defined as A3 injury. Radiographic data and functional outcome of A3 injury patients were reviewed to explore the characteristics and surgical strategy.
Read the detailed description
Fracture data, surgical incision, operation time, blood loss, fracture healing， Reduction quality，functional outcome，and relevant complications
- Conditions
- Acetabular Fracture
- Being tested
- KL, Iliofemoral, Ilioinguinal, Iliac fossa and combined approaches
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KL, Iliofemoral, Ilioinguinal, Iliac fossa and combined approachesProcedure or surgery
Also called Fracture types
A3.1, A3.2, A3.3
| Study group | Role | What they receive |
|---|---|---|
| fracture types | A3.1, A3.2, A3.3 Receives: Procedure: KL, Iliofemoral, Ilioinguinal, Iliac fossa and combined approaches |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative outcome
Merle d'Aubigné score, fracture healing, reduction quality, etc
Measured: 4 months
Secondary outcomes (1)
complication
wound infection, iatrogenic injury of vessels and nerves, etc
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start1 Jan 2024
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Why it stopped: Due to limited funding, the study is now being withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acetabular 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruipeng Zhang, Hebei Medical University Third Hospital
- Investigators
- Zhiyong Hou, MD, Study chair, Hebei Medical University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238804
- Sponsor's protocol ID
- ZRP2024
- Acronym
- CASEARF
- Status last verified
- Apr 2024
- First submitted
- 23 Jan 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used and analyzed during the current study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristic Analysis and Surgical Exploration for Acetabular Roof Fractures: Multicenter Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06238804
- Acronym / sponsor ID
- CASEARF / ZRP2024
- Conditions
- Acetabular Fracture
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Due to limited funding, the study is now being withdrawn.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hebei Medical University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 2 Feb 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.
Acetabular roof was a crucial structure for maintaining the stability of hip joint; however, its important role was not especially emphasized in the Letournel-Judet classification system. Acetabular roof was segmented into the roof column and roof wall in Three-column classification and fracture in this area alone was defined as A3 injury. Radiographic data and functional outcome of A3 injury patients were reviewed to explore the characteristics and surgical strategy.
Detailed description
Fracture data, surgical incision, operation time, blood loss, fracture healing， Reduction quality，functional outcome，and relevant complications
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fracture types | – | Procedure: KL, Iliofemoral, Ilioinguinal, Iliac fossa and combined approachesA3.1, A3.2, A3.3 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients met the inclusion criteria were collected in this study.
Key inclusion criteria (1 listed)
- 18-80 years, acute (<14 days) closed roof column/wall acetabular fractures (A3.1, A3.2 or A3.3) in Three-column classification, normal activity of the affected hip before the injury, received surgical reduction and internal fixation
Key exclusion criteria (1 listed)
- open fractures, pathologic fractures, limited range of motion (ROM) of the hip joint before the injury, conservative treatment, risk factors affecting bone healing (such as smoking and metabolic diseases) and noncompletion of the two-year follow-up
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 |
|---|---|---|
| KL, Iliofemoral, Ilioinguinal, Iliac fossa and combined approachesAlso: Fracture typesA3.1, A3.2, A3.3 | Procedure or surgery | fracture types |
Primary outcome
postoperative outcome
Time frame: 4 months
Merle d'Aubigné score, fracture healing, reduction quality, etc
1 secondary outcome
complication
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: No. The datasets used and analyzed during the current study are available from the corresponding author on reasonable request.
Related trials for Acetabular Fracture
Not yet recruitingObservational study
3D-Printed Pelvic Models for Planning Complex Total Hip Arthroplasty
Developmental Dysplasia of the Hip, Acetabular Bone Loss
Active, not recruitingPhase 2
Stoppa Approach Vs Anterior & Posterior Fixation in Management of BC Fracture Acetabulum
Evaluation of Isolated Stoppa Approach in BC Fracture Acetabulum
RecruitingObservational study
Pelvic and Acetabular Fracture: A Prospective Observational Study
Pelvic Fracture, Acetabular Fracture
Recruiting
Pericapsular Nerve Group (PENG) Block on Postoperative Pain Management After Acetabular Fracture Fixation
Acetabular Fractures
Not yet recruitingObservational study
Functional and Radiological Outcomes of Pediatric Acetabular Fracture Management
Acetabular Fractures in Pediatrics
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.
Zhiyong Hou, MD study chair
Hebei Medical University Third Hospital
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 Acetabular Fracture, run by Hebei Medical University Third Hospital at 1 site in China.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 9 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 China. 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 was withdrawn before enrolling participants, so there are no results.
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?
postoperative outcome (time frame: 4 months). 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 Apr 2024.