NCT06856980

Syndesmotic Screw Vs Suture Button in Ankle Syndesmotic Diastasis

Comparative Study Between Syndesmotic Screw and Suture Button in Ankle Syndesmotic Diastasis

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to compare suture-button versus syndesmotic screw in the treatment of distal tibiofibular syndesmotic injury.

Detailed description

The term syndesmotic injury is used to describe a lesion of the ligaments that connect the distal fibula and the tibial notch surrounded on both sides by the anterior and posterior tibial tubercles, with or without an associated injury of the deltoid ligament. Accuracy and maintenance of syndesmosis reduction are considered the key elements in the treatment of ankle fractures. Screw fixation is considered the gold standard treatment for an unstable syndesmosis injury. Button and suture construction with a medial-lateral metallic button and suture system offers an alternative method for repairing the distal tibio-fibular joint. Suture-button design has been shown to maintain the reduction, facilitating physiologic stability of the ankle mortise. This may allow early physiological motion, leading to earlier ligament healing and potentially earlier loading, which may produce better clinical results. However, this system is more expensive than the screw method and it may gradually relax under weightbearing conditions. Therefore, whether this device is a suitable alternative, and how many devices are needed for adequate stability are not yet known.

Conditions

• Syndesmotic Screw
• Suture Button
• Fixation
• Ankle Syndesmotic Diastasis

Interventions

Type	Name	Description
PROCEDURE	Suture button fixation	Patients undergoing suture button fixation of syndesmosis injury.
PROCEDURE	Syndesmotic screw fixation	Patients undergoing syndesmotic screw fixation of syndesmosis injury.

Timeline

• Start date: 2025-03-15
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2025-03-04
• Last updated: 2025-03-06

Locations

1 site across 1 country: Egypt