- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04073329
Acetabular Fracture Reduction Assessment
Assessing Postoperative Reduction Following Acetabular Fracture Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Osama Farouk, MD
- Phone Number: 00201222443531
- Email: osama_farouk@yahoo.com
Study Contact Backup
- Name: Mahmoud Badran, MD
- Phone Number: 00201000341878
- Email: m_badran80@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
Inclusion Criteria:
- Isolated displaced acetabular fractures
- Skeletally mature patients
Exclusion Criteria:
- Skeletally Immature
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Plain x ray
measurement the accuracy of post operative reduction by Matta method
|
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.
|
|
CT
measure the accuracy of reduction by Verbeek method
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Verbeek 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.
- Dodd 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AFRA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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