NCT01109303

Static Implant Versus Dynamic Implant in the Surgical Treatment on Ankle Syndesmosis Rupture

Prospective Randomized Multicentric Trial Comparing a Static Implant and a Dynamic Implant in the Surgical Treatment of Ankle Syndesmosis Rupture

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Hopital de l'Enfant-Jesus · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Ankle fracture is frequent and its number is increasing. In Canada, surgical treatment of these lesions is advised and the options currently used all have in common a rigid fixation of the syndesmosis which results in residual stiffness and a high level of secondary surgery, mostly to remove the implant. The purpose of the study is to compare the treatment of ankle syndesmotic rupture by a dynamic fixation to a static fixation suggesting that the dynamic fixation method will improve the Olerud-Molander functional score of more than 15 points at the 3 months follow-up.

Conditions

• Ankle Syndesmosis Rupture

Interventions

Type	Name	Description
PROCEDURE	TightRope System- Arthrex® / Dynamic Implant	Patients are operated on using a dynamic implant, the TightRope System by Arthrex®. The ankle is immobilized in a plaster boot for 6 weeks.
PROCEDURE	Screw fixation - Synthes® / Static Implant	Patients are operated on using a static implant, the rigid four-cortices 3,5 mm screw fixation by Synthes®. The ankle is immobilized in a plaster boot for 6 weeks.

Timeline

• Start date: 2008-10-01
• Primary completion: 2011-02-01
• Completion: 2012-01-01
• First posted: 2010-04-23
• Last updated: 2012-12-20

Locations

1 site across 1 country: Canada