NCT02930486

Ziptight or Tricortical Screw Fixation of Acute Tibiofibular Syndesmotic Injury

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Vestre Viken Hospital Trust · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Treatment of syndesmotic injury with Weber C fracture. A randomized study comparing ZipTight suture endobutton and one tricortical 3,5 mm syndesmotic screw.

Detailed description

Syndesmotic injuries are common and often associated with unstable ankle fractures. The most common treatment is with a syndesmotic screw through the fibula and tibia which is later removed, usually after 10-12 weeks. The ZipTight suture endobutton (Biomet) is used for the same indication. It does not need removal and thus avoids subsequent surgery. This trial will compare these two methods and see if they are equal. patients 18-70 years presenting to one of the three hospitals with and acute syndesmotic injury are eligible for inclusion. 120 patients are randomized to two treatment groups. One group will be treated with a ZipTight suture endobutton fixation and the other receives a tricortical screw fixation. Neither suture endobutton or screw is routinely removed. Follow up intervals are at 6 weeks, 6, 12 and 24 months with clinical and-points. Standardized CT scans are taken postoperatively and at 12 and 24 months.

Conditions

• Ankle Fractures

Interventions

Type	Name	Description
DEVICE	ZipTight suture endobutton	Zimmer Biomet ZipTight suture endobutton
DEVICE	Tricortical 3.5 mm syndesmotic screw	Depuy Synthes 3.5 mm screw

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-09-30
• Completion: 2019-10-01
• First posted: 2016-10-12
• Last updated: 2019-11-29

Locations

1 site across 1 country: Norway