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A Prospective Randomized Controlled Trial of Dynamic Fixation for Complex Ankle Fractures With Syndesmotic Diastasis.
Sponsor: Fuzhou University Affiliated Provincial Hospital
Summary
This prospective randomized controlled trial aims to evaluate the clinical effectiveness of dynamic fixation in patients with complex ankle fractures associated with syndesmotic diastasis. Patients undergoing surgical treatment for complex ankle fractures with syndesmotic diastasis at Fujian Provincial Hospital Affiliated with Fuzhou University between October 2026 and October 2027 will be enrolled. Eligible participants will be randomly assigned in a 1:1 ratio to either the screw fixation (SF) group or the dynamic fixation (DF) group. All participants will be followed for 12 months after surgery. Clinical, functional, and radiographic outcomes will be compared between the two groups to assess the effectiveness and safety of dynamic fixation. Statistical analyses will be performed using IBM SPSS Statistics version 27.0. The primary analysis will follow the intention-to-treat principle. Appropriate statistical methods will be selected according to the type and distribution of the data. Multivariable regression analyses will be performed when necessary to adjust for potential confounding factors. Missing data will be handled using multiple imputation where appropriate, and sensitivity analyses will be conducted to evaluate the robustness of the findings. All statistical tests will be two-sided, with a P\<0.05 considered statistically significant.
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-10-01
Completion Date
2028-10-01
Last Updated
2026-09-21
Healthy Volunteers
No
Interventions
the dynamic fixation
Randomized controlled grouping was conducted under blind conditions, followed by treatment of complex ankle fractures with distal tibiofibular syndesmosis separation using dynamic internal fixation surgical methods.
the screw fixation
"Randomized controlled grouping was conducted under blind conditions, followed by treatment of complex ankle fractures with distal tibiofibular syndesmosis separation using screw fixation surgical methods.