Kasr Alainy
Cairo, Egypt
NCT Number: NCT07338149
This prospective observational cohort study aims to evaluate the ability of postoperative plain radiographs to detect syndesmotic reduction accuracy in patients with ankle fractures requiring syndesmotic fixation. All included patients have acceptable postoperative radiographs according to standard radiographic criteria and undergo postoperative computed tomography to further assess syndesmotic reduction. Functional outcomes are assessed at one year following surgery using a standardized ankle functional score. The study seeks to explore the association between computed tomography-detected syndesmotic malreduction and postoperative functional outcome.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Observational
Cairo, Egypt
Accurate reduction of the distal tibiofibular syndesmosis is essential for restoring ankle stability and achieving favorable functional outcomes after ankle fracture fixation. Plain radiographs are routinely used to assess postoperative syndesmotic reduction; however, subtle malreductions may not be detected using standard radiographic views alone.
This prospective observational cohort study includes adult patients with ankle fractures requiring operative fixation and syndesmotic stabilization who demonstrate acceptable postoperative plain radiographs. As part of postoperative evaluation, all included patients undergo computed tomography imaging to provide a more detailed assessment of syndesmotic reduction, particularly with respect to rotational and translational alignment of the distal fibula relative to the tibia.
Based on computed tomography findings, syndesmotic reduction is categorized according to predefined criteria. Functional outcomes are assessed at 12 months postoperatively using the American Orthopaedic Foot and Ankle Society ankle-hindfoot score. The study is observational in nature, and imaging findings do not influence postoperative management or treatment decisions.
The objective of this study is to assess the limitations of plain radiographs in detecting syndesmotic malreduction and to evaluate the association between computed tomography findings and functional outcomes following ankle fracture fixation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 12 months postoperatively
Functional outcome of the affected ankle assessed using the American Orthopaedic Foot and Ankle Society (AOFAS) ankle-hindfoot score, which evaluates pain, function, and alignment on a 0-100 point scale, with higher scores indicating better function.
Time frame: within 1 week after surgery
Accuracy of distal tibiofibular syndesmotic reduction assessed using postoperative computed tomography imaging, based on predefined radiological criteria evaluating translational and rotational alignment of the distal fibula relative to the tibia.
Cairo University
Other
Detection of Syndesmotic Malreduction by Postoperative Computed Tomography in Ankle Fractures With Acceptable Radiographs: A Prospective Cohort Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05412693
Ankle Fractures, Ankle Injuries
Ålesund, Norway
View Trial DetailsNCT05662449
Ankle Fractures, Ankle Injuries
Aberdeen, United Kingdom
View Trial DetailsNCT05494645
Ankle Fractures, Ankle Injuries
Bethlehem, Pennsylvania, United States
View Trial DetailsNCT03809520
Ankle Fractures, Ankle Injuries
Iowa City, Iowa, United States
View Trial Details