Ankle FracturesNCT07831265
Dynamic Fixation for Complex Ankle Fractures With Syndesmotic Diastasis.
A study testing the dynamic fixation and the screw fixation in people with Ankle Fractures and Syndesmotic Injury of the Ankle, run by Fuzhou University Affiliated Provincial Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Ankle Fractures, Syndesmotic Injury of the Ankle
- What is being tested?
- the dynamic fixation and the screw fixation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
- Able to comply with follow-up and sign a written informed consent
- Ankle function was basically normal before injury
Who cannot join
- Age <18 or >55
- Pathological fracture
- Previous ankle surgery or serious primary ankle disease
- Time from injury to surgery >2 weeks
- Active infection or serious medical condition
- Severe neurological or psychiatric disorder affecting follow-up compliance
- Postmenopausal women
- Other situations not suitable for enrollment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Randomized Controlled Trial of Dynamic Fixation for Complex Ankle Fractures With Syndesmotic Diastasis.
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.
- Conditions
- Ankle Fractures, Syndesmotic Injury of the Ankle
- Being tested
- the dynamic fixation, the screw fixation
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the dynamic fixationDevice
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 fixationDevice
"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.
| Study group | Role | What they receive |
|---|---|---|
| the screw fixation group | Active comparator | Not described Receives: Device: the screw fixation |
| the dynamic fixation group | Experimental | Not described Receives: Device: the dynamic fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperative; 1 week, 1 month, 3 months, 6 months, 1 year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fuzhou University Affiliated Provincial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zun Lin Cai, Fuzhou University Affiliated Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831265
- Sponsor's protocol ID
- K2026-09-013
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial of Dynamic Fixation for Complex Ankle Fractures With Syndesmotic Diastasis.
- ClinicalTrials.gov ID
- NCT07831265
- Acronym / sponsor ID
- K2026-09-013
- Conditions
- Ankle Fractures, Syndesmotic Injury of the Ankle
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fuzhou University Affiliated Provincial HospitalUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the screw fixation group | Active comparator | Device: the screw fixation |
| the dynamic fixation group | Experimental | Device: the dynamic fixation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
- Able to comply with follow-up and sign a written informed consent
Key exclusion criteria (8 listed)
- Age <18 or >55
- Pathological fracture
- Previous ankle surgery or serious primary ankle disease
- Time from injury to surgery >2 weeks
- Active infection or serious medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the dynamic fixationRandomized 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. | Device | the dynamic fixation group |
| 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. | Device | the screw fixation group |
Primary outcome
The American Orthopaedic Foot and Ankle Society (AOFAS)
Time frame: Preoperative; 1 week, 1 month, 3 months, 6 months, 1 year postoperative
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing the dynamic fixation and the screw fixation in people with Ankle Fractures and Syndesmotic Injury of the Ankle, run by Fuzhou University Affiliated Provincial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ZunLinCai (86+15345912057, 2893761828@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The American Orthopaedic Foot and Ankle Society (AOFAS) (time frame: Preoperative; 1 week, 1 month, 3 months, 6 months, 1 year postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.