Syndesmotic Screw in Neutral Position Versus Maximum Ankle Dorsiflexion in

Status Recruiting

Clinical Trial Summary

Ankle fracture is one of the most common orthopedic injuries. Approximately, 20% of surgically treated ankle fractures are associated with syndesmotic instability.According to the mechanism of the injury the syndesmotic disruption should be considered in Danis-Weber C-type fractures. However, such injuries were also frequently seen in Danis-Weber B-type fractures. Failure to detect and repair syndesmotic injuries early may result in poor clinical outcomes and complications affecting ankle function, such as long-term residual pain, post traumatic arthritis, and ankle impingement syndromes. Therefore, aggressive treatment is important when facing syndesmotic instability . The distal tibiofibular syndesmosis is important for stability of the ankle mortise and thus for weight transmission and walking. Syndesmotic injuries are most commonly associated with fibular fractures, but they can also occur in isolation or with damage to the lateral ankle ligament after traumatic supination. The need for syndesmotic fixation of the distal tibiofibular joint has been controversia. fracture does not correlate reliably with the extent of the interosseous membrane tears identified on MRI of ankle fractures, and thus estimation of the integrity of the interosseous membrane and subsequent need for trans-syndesmotic fixation cannot be based solely on the level of the fibular fracture. An intraoperative syndesmotic stress test can establish the presence or absence of syndesmotic instability, evaluating the integrity of the syndesmosis by grasping the stabilised fibula with a hook or clamp and pulling it laterally. If more than 3 or 4 mm of lateral displacement occurs, syndesmotic fixation is necessary. Most authors recommend surgical placement of a trans-fixation screw after anatomical reduction of the syndesmosis if a disruption is diagnosed to avoid complications.The main aims of treatment for dislocation of the distal tibiofibular syndesmosis are to restore the original anatomy and normal function and to recreate the stability of the ankle joint. The syndesmosis is traditionally fixed with a metallic screw, which is a method that has been used for decades and demonstrates good to excellent outcomes. Some surgeons prefer Fixation of syndesmosis with screw in maximum ankle dorsiflexion and others prefer fixation in neutral position of ankle.in this study we are going to compare between these two

Clinical Trial Description

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Study Design

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Clinical Trial Details

NCT number	NCT06313177
Study type	Interventional
Source	Sohag University
Contact	mahmoud asaad, resident
Phone	01114377005
Email	mahmoudasaad339@gmail.com
Status	Recruiting
Phase	N/A
Start date	March 10, 2024
Completion date	March 10, 2025

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See also
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Not yet recruiting	`NCT04933045` - Treatment of Syndesmotic Disruption With Anatomic Distal Tibiofibular Ligament Augmentation
Active, not recruiting	`NCT05062265` - Internal Brace Augmented Anterior Inferior Tibiofibular Ligament Repair: Post-operative Syndesmotic Volumes.	N/A
Completed	`NCT05190874` - Grappler Interference Screw Post-Market Collection of Patient Reported Outcome Measures
Recruiting	`NCT05626036` - Randomized Controlled Trial Comparing Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries	N/A
Recruiting	`NCT05625516` - Bilateral External Torque CT, a Novel Diagnostic Tool for Detection of Syndesmotic Insufficiency
Recruiting	`NCT05445960` - Correlation Between Intraoperative Tourniquet Use and Limb pH, Functional Measures and Patient-reported Outcomes After Ankle Fracture Surgery	N/A
Completed	`NCT04893824` - Grappler® Interference Screw Post-Market Clinical Follow-Up Study
Recruiting	`NCT05662449` - A Cohort Study of Bioabsorbable Screws for Syndesmosis Fixation Fixation in Ankle Fracture

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Syndesmotic Screw in Neutral Position Versus Maximum Ankle Dorsiflexion in Ankle Fractures; Comparative Study.

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms