NCT01275924

Tightrope or Screw Fixation of Acute Tibiofibular Syndesmotic Injury

Tightrope or Screw Fixation of Acute Tibiofibular Syndesmotic Injury. Randomised Controlled Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Sykehuset Asker og Baerum · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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 Tightrope Syndesmosis Repair Kit (Arthrex; Naples, Florida). is used for the same indication, it consists of a heavy suture placed across the syndesmosis which has been looped and tightened through cortical button anchors on either side of the ankle. It does not need removal and thus avoids subsequent surgery. This trial compares these two treatment methods for syndesmotic injuries of the ankle.

Detailed description

Patients 18-70 years presenting to one of the two hospitals with an acute syndesmotic injury are eligible for inclusion. 50 patients are randomised to two treatment groups: One group receives a Tightrope (R) fixation and the other receives a quadricortical screw fixation which is removed after 12 weeks. Follow-up intervals are at 6 weeks, 6, 12 and 24 months with standardised CT scans postoperatively and at 12, 24 months and 5 years clinical end-ponts/scores.

Conditions

• Syndesmotic Injury of the Ankle

Interventions

Type	Name	Description
DEVICE	Tightrope Syndesmosis Repair Kit	Tightrope Syndesmosis Repair Kit
DEVICE	Syndesmotic screw	Quadricortical syndesmotic screw

Timeline

• Start date: 2011-01-01
• Primary completion: 2015-03-01
• Completion: 2018-04-01
• First posted: 2011-01-13
• Last updated: 2018-04-18

Locations

2 sites across 1 country: Norway