A Prospective Randomized Controlled Trial of Dynamic Fixation for Complex Ankle Fractures With Syndesmotic Diastasis.

N/ANot Yet RecruitingNCT07831265

Fuzhou University Affiliated Provincial Hospital100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Ankle Fractures

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 18-55 years; 2. Radiologically confirmed complex ankle fracture combined with distal tibiofibular syndesmosis separation; 3. First-time surgical treatment of the ankle; 4. Time from injury to surgery ≤ 2 weeks; 5. Able to comply with follow-up and sign a written informed consent; 6. Ankle function was basically normal before injury. Exclusion Criteria: 1\. Age \<18 or \>55; 2. Pathological fracture; 3. Previous ankle surgery or serious primary ankle disease; 4. Time from injury to surgery \>2 weeks; 5. Active infection or serious medical condition; 6. Severe neurological or psychiatric disorder affecting follow-up compliance; 7. Postmenopausal women; 8. Other situations not suitable for enrollment

A Prospective Randomized Controlled Trial of Dynamic Fixation for Complex Ankle Fractures With Syndesmotic Diastasis.

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Central Contacts