Ankle Syndesmosis Rupture Clinical Trial
Official title:
Prospective Randomized Multicentric Trial Comparing a Static Implant and a Dynamic Implant in the Surgical Treatment of Ankle Syndesmosis Rupture
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment