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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.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Baerum Hospital, Vestre Viken
Sandvika, Gjettum, Norway
Start Date
January 1, 2016
Primary Completion Date
September 30, 2017
Completion Date
October 1, 2019
Last Updated
November 29, 2019
120
ACTUAL participants
ZipTight suture endobutton
DEVICE
Tricortical 3.5 mm syndesmotic screw
DEVICE
Lead Sponsor
Vestre Viken Hospital Trust
Collaborators
NCT06085586
NCT06709365
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06518265