Dynamic Fixation for Complex Ankle Fractures With Syndesmotic Diastasis.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorFuzhou University Affiliated Provincial Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-55 years
Radiologically confirmed complex ankle fracture combined with distal tibiofibular syndesmosis separation
First-time surgical treatment of the ankle
Time from injury to surgery ≤ 2 weeks
Disqualifiers
Age <18 or >55
Pathological fracture
Previous ankle surgery or serious primary ankle disease
Time from injury to surgery >2 weeks
Trial design
Design model
Parallel
Treatments tested in this trial
the dynamic fixation
DeviceRandomized 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
Device"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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: the screw fixation groupActive comparator 1 intervention
Group B: the dynamic fixation groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The American Orthopaedic Foot and Ankle Society (AOFAS)
The American Orthopaedic Foot and Ankle Society (AOFAS) , Ankle-Hindfoot Score ranges from a minimum of 0 to a maximum of 100, with higher scores indicating better ankle-hindfoot function and fewer symptoms.
Time frame
Preoperative; 1 week, 1 month, 3 months, 6 months, 1 year postoperativeLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: