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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04073329
Other study ID # AFRA
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 2023
Est. completion date September 2024

Study information

Verified date November 2022
Source Assiut University
Contact Osama Farouk, MD
Phone 00201222443531
Email osama_farouk@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date September 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 16 Years to 65 Years
Eligibility Inclusion Criteria: - Isolated displaced acetabular fractures - Skeletally mature patients Exclusion Criteria: - Skeletally Immature

Study Design


Related Conditions & MeSH terms


Intervention

Other:
post operative measure of reduction
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (3)

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 year
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