An interventional study of the dynamic fixation and the screw fixation in Ankle Fractures and Syndesmotic Injury of the Ankle, sponsored by Fuzhou University Affiliated Provincial Hospital. Not yet recruiting. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Fuzhou University Affiliated Provincial Hospital · Not applicable, Interventional, and Treatment
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.
202 studies on the registry are indexed under Ankle Fractures; 44 are open to participants now.
This study's planned enrollment of 100 is above the median of 90 across 150 interventional studies indexed under Ankle Fractures.
Browse Ankle Fractures studies →Fuzhou University Affiliated Provincial Hospital is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: the screw fixation
Device: 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.
"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.
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 postoperative
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Oct 2028, 24 months later.
Of 69 non-industry interventional studies with no phase under Ankle Fractures, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 61. This study's planned 24 months is below that.
Counting every sponsor, half of 72 studies reached it within 45 months; a quarter within 23 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Fuzhou University Affiliated Provincial Hospital