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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Zimmer Biomet ZipTight suture endobutton
Depuy Synthes 3.5 mm screw
Baerum Hospital, Vestre Viken
Sandvika, Gjettum, Norway
OTA Score (Modified American Orthopaedic Foot and Ankle Society ankle hind foot score)
Modified American Orthopaedic Foot and Ankle Society ankle hind foot score (0-100)
Time frame: 24 months
Manchester-Oxford Foot questionnaire (MOxFQ)
Time frame: 24 months
Dorsiflexion angle
according to Lindsjø
Time frame: 24 months
Health-related quality of life (EQ-5D)
Time frame: 24 months
CT measurements of syndesmotic distance
Time frame: 24 months
VAS
visual analogue scale
Time frame: 24 months
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