Acetabular FractureNCT04073329
Acetabular Fracture Reduction Assessment
An observational study of Acetabular Fracture, run by Assiut University.
Trial summary
It is widely accepted in the literature that quality of acetabular fracture reduction is one of the most important factor for the outcome. To obtain best results, anatomical reduction has to be obtained. Intra-operative radiographic assessment depends mainly on plain x-ray. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Acetabular Fracture
- What is being tested?
- post operative measure of reduction
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Sep 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients included in our study will have postoperative plain X-rays and comparing it to CT scan to assess their quality of reduction and other criteria mentioned in the literature. 10 observers with different years of experience will assess all fractures using plain x-ray and CT.
Who may be able to join
- Isolated displaced acetabular fractures
- Skeletally mature patients
Who cannot join
- Skeletally Immature
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessing Postoperative Reduction Following Acetabular Fracture Surgery
It is widely accepted in the literature that quality of acetabular fracture reduction is one of the most important factor for the outcome. To obtain best results, anatomical reduction has to be obtained. Intra-operative radiographic assessment depends mainly on plain x-ray. Plain x-ray alone is not enough for post-operative assessment as it depends mainly on reduction of the dome with concentricity of the hip.
Read the detailed description
It is widely accepted in the literature that quality of acetabular fracture reduction is one of the most important factor for the outcome. To obtain best results, anatomical reduction has to be obtained. Intra-operative radiographic assessment depends mainly on plain x-ray. Plain x-ray alone is not enough for post-operative assessment as it depends mainly on reduction of the dome with concentricity of the hip. Complex fractures with multi-fragmentary fracture pattern, impacted fragments (marginal or roof), fractures with osteo-chondral loss and associated head of femur injuries, pose problems with reduction assessment using both Plain x-ray and CT due to lack of clear standardized way of assessment. Matta criteria has been used widely in the literature for assessment, however it lacks some important criteria which directly related to the functional outcome. Few papers in the literature address this problem and reporting some ways for assessment but with lack of testing and reproducibility.
Since there is in our level 1 trauma center a lot of cases of acetabular fractures that is admitted yearly to our center Purpose of our study is to use those methods for our cases in order to test their validity and reproducibility
- Conditions
- Acetabular Fracture
- Being tested
- post operative measure of reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
post operative measure of reductionOther
measurement was used to grade quality of reduction according to Matta's system . In accordance with prior studies, adequate (or anatomic) reductions with 0-1 mm of displacement were compared to inadequate (imperfect or poor) reductions with > 1 mm displacement . For the CT-based method, postoperative pre-digital (prior to 2000) and digital CT images were independently assessed in the axial, sagittal, and coronal planes, and residual gap and step displacement were measured along the articular surface at the level of the weight-bearing dome. Adequate reductions on postoperative CT were defined as < 1 mm step and < 5 mm gap displacement and inadequate reductions as ≥ 1 mm step and/or ≥ 5 mm gap displacement.
| Study group | Role | What they receive |
|---|---|---|
| Plain x ray | measurement the accuracy of post operative reduction by Matta method Receives: Other: post operative measure of reduction | |
| CT | measure the accuracy of reduction by Verbeek method Receives: Other: post operative measure of reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of CT scans and plain radiographs to detect residual articular steps and gaps after healing of acetabular fractures managed by open reduction and internal fixation.
measurement was used to grade quality of reduction according to Matta's system . In accordance with prior studies, adequate (or anatomic) reductions with 0-1 mm of displacement were compared to inadequate (imperfect or poor) reductions with > 1 mm displacement . For the CT-based method, postoperative pre-digital (prior to 2000) and digital CT images were independently assessed in the axial, sagittal, and coronal planes, and residual gap and step displacement were measured along the articular surface at the level of the weight-bearing dome. Adequate reductions on postoperative CT were defined as < 1 mm step and < 5 mm gap displacement and inadequate reductions as ≥ 1 mm step and/or ≥ 5 mm gap displacement.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study startOct 2023 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acetabular 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahaaeldin Mohamed Abdelhafez, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073329
- Sponsor's protocol ID
- AFRA
- Status last verified
- Nov 2022
- First submitted
- 27 Aug 2019
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Borrelli J Jr, Ricci WM, Steger-May K, Totty WG, Goldfarb C. Postoperative radiographic assessment of acetabular fractures: a comparison of plain radiographs and CT scans. J Orthop Trauma. 2005 May-Jun;19(5):299-304.
PubMed 15891537Verbeek DO, van der List JP, Helfet DL. Computed tomography versus plain radiography assessment of acetabular fracture reduction is more predictive for native hip survivorship. Arch Orthop Trauma Surg. 2019 Dec;139(12):1667-1672. doi: 10.1007/s00402-019-03192-w. Epub 2019 Apr 27.
PubMed 31030241Dodd A, Osterhoff G, Guy P, Lefaivre KA. Radiographic Measurement of Displacement in Acetabular Fractures: A Systematic Review of the Literature. J Orthop Trauma. 2016 Jun;30(6):285-93. doi: 10.1097/BOT.0000000000000538.
PubMed 27206254
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Postoperative Reduction Following Acetabular Fracture Surgery
- ClinicalTrials.gov ID
- NCT04073329
- Acronym / sponsor ID
- AFRA
- Conditions
- Acetabular Fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 29 Aug 2019 (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.
It is widely accepted in the literature that quality of acetabular fracture reduction is one of the most important factor for the outcome. To obtain best results, anatomical reduction has to be obtained. Intra-operative radiographic assessment depends mainly on plain x-ray. Plain x-ray alone is not enough for post-operative assessment as it depends mainly on reduction of the dome with concentricity of the hip.
Detailed description
It is widely accepted in the literature that quality of acetabular fracture reduction is one of the most important factor for the outcome. To obtain best results, anatomical reduction has to be obtained. Intra-operative radiographic assessment depends mainly on plain x-ray. Plain x-ray alone is not enough for post-operative assessment as it depends mainly on reduction of the dome with concentricity of the hip. Complex fractures with multi-fragmentary fracture pattern, impacted fragments (marginal or roof), fractures with osteo-chondral loss and associated head of femur injuries, pose problems with reduction assessment using both Plain x-ray and CT due to lack of clear standardized way of assessment. Matta criteria has been used widely in the literature for assessment, however it lacks some important criteria which directly related to the functional outcome. Few papers in the literature address this problem and reporting some ways for assessment but with lack of testing and reproducibility.
Since there is in our level 1 trauma center a lot of cases of acetabular fractures that is admitted yearly to our center Purpose of our study is to use those methods for our cases in order to test their validity and reproducibility
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plain x ray | – | Other: post operative measure of reductionmeasurement the accuracy of post operative reduction by Matta method |
| CT | – | Other: post operative measure of reductionmeasure the accuracy of reduction by Verbeek method |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients included in our study will have postoperative plain X-rays and comparing it to CT scan to assess their quality of reduction and other criteria mentioned in the literature. 10 observers with different years of experience will assess all fractures using plain x-ray and CT.
Key inclusion criteria (2 listed)
- Isolated displaced acetabular fractures
- Skeletally mature patients
Key exclusion criteria (1 listed)
- Skeletally Immature
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 |
|---|---|---|
| post operative measure of reductionmeasurement was used to grade quality of reduction according to Matta's system . In accordance with prior studies, adequate (or anatomic) reductions with 0-1 mm of displacement were compared to inadequate (imperfect or poor) reductions with > 1 mm displacement . For the CT-based method, postoperative pre-digital (prior to 2000) and digital CT images were independently assessed in the axial, sagittal, and coronal planes, and residual gap and step displacement were measured along the articular surface at the level of the weight-bearing dome. Adequate reductions on postoperative CT were defined as < 1 mm step and < 5 mm gap displacement and inadequate reductions as ≥ 1 mm step and/or ≥ 5 mm gap displacement. | Other | CT, Plain x ray |
Primary outcome
Ability of CT scans and plain radiographs to detect residual articular steps and gaps after healing of acetabular fractures managed by open reduction and internal fixation.
Time frame: 1 year
measurement was used to grade quality of reduction according to Matta's system . In accordance with prior studies, adequate (or anatomic) reductions with 0-1 mm of displacement were compared to inadequate (imperfect or poor) reductions with > 1 mm displacement . For the CT-based method, postoperative pre-digital (prior to 2000) and digital CT images were independently assessed in the axial, sagittal, and coronal planes, and residual gap and step displacement were measured along the articular surface at the level of the weight-bearing dome. Adequate reductions on postoperative CT were defined as < 1 mm step and < 5 mm gap displacement and inadequate reductions as ≥ 1 mm step and/or ≥ 5 mm gap displacement.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Background: PubMed 15891537Borrelli J Jr, Ricci WM, Steger-May K, Totty WG, Goldfarb C. Postoperative radiographic assessment of acetabular fractures: a comparison of plain radiographs and CT scans. J Orthop Trauma. 2005 May-Jun;19(5):299-304.
- Background: PubMed 31030241Verbeek DO, van der List JP, Helfet DL. Computed tomography versus plain radiography assessment of acetabular fracture reduction is more predictive for native hip survivorship. Arch Orthop Trauma Surg. 2019 Dec;139(12):1667-1672. doi: 10.1007/s00402-019-03192-w. Epub 2019 Apr 27.
- Background: PubMed 27206254Dodd A, Osterhoff G, Guy P, Lefaivre KA. Radiographic Measurement of Displacement in Acetabular Fractures: A Systematic Review of the Literature. J Orthop Trauma. 2016 Jun;30(6):285-93. doi: 10.1097/BOT.0000000000000538.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acetabular Fracture, run by Assiut University.
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 2 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: status not confirmed, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Osama Farouk, MD (00201222443531, osama_farouk@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability of CT scans and plain radiographs to detect residual articular steps and gaps after healing of acetabular fractures managed by open reduction and internal fixation. (time frame: 1 year). 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 NCT04073329, which also lists 3 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 14 Nov 2022.