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Dynamic Fixation for Complex Ankle Fractures With Syndesmotic Diastasis.

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Fuzhou University Affiliated Provincial Hospital

Record History

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  1. Primary endpoint(s) modified
    • Eligibility criteria revised
    • Study title shortened, about 6 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07831265
Lead Sponsor Fuzhou University Affiliated Provincial Hospital
Conditions
(from sponsor)		 Ankle Fractures, Syndesmotic Injury of the Ankle
Related terms Ankle Fractures
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov