Ankle Fractures Clinical Trial
Official title:
Ziptight or Tricortical Screw Fixation of Acute Tibiofibular Syndesmotic Injury
Treatment of syndesmotic injury with Weber C fracture. A randomized study comparing ZipTight suture endobutton and one tricortical 3,5 mm syndesmotic screw.
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.
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