Screw Versus Tightrope Syndesmotic Injury Fixation in Weber C Ankle Fractures
1 other identifier
interventional
38
1 country
1
Brief Summary
The aim of our study is to compare two different syndesmosis transfixation methods in AO/OTA Weber C ankle fractures. Our hypothesis is that 50% of screw fixed fibulas but only 5% of suture-button fixed fibulas are in malposition. All skeletally mature patients (16 years or older) with AO/OTA Weber C type fractures operated within a week after trauma are consecutively included into the study. The tibiofibular transfixation is randomly performed either by a 3,5 mm tricortical screw or a suture-button (TightRope). Malposition of the tibiofibular joint is assessed in an intraoperative computed tomography. Clinical outcome is assessed by using Olerud-Molander, RAND ja 36-Item Healt Survey after 1-year from the injury.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 12, 2012
CompletedFirst Posted
Study publicly available on registry
December 5, 2012
CompletedMay 16, 2016
May 1, 2016
1.4 years
June 12, 2012
May 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Malreduction of the tibiofibular joint in the intraoperative computed tomography
Malreduction in the tibiofibular joint is assessed post op from the intraoperative computed tomography. Both ankles are imaged and difference at least 2 mm is assessed to be significant
2 years
Secondary Outcomes (1)
Clinical outcome one year after the injury
2 year
Study Arms (2)
Screw fixation
ACTIVE COMPARATOR3,5mm fully threaded cortical screw transfixation of syndesmosis
TightRope
ACTIVE COMPARATORTightRope transfixation of syndesmosis
Interventions
3,5mm fully threaded cortical screw transfixation of syndesmosis
Eligibility Criteria
You may qualify if:
- AO/OTA Weber C ankle fracture, operation within 7 days from the injury
You may not qualify if:
- Bilateral or previous ankle fracture, tibial shaft fracture, diabetes wiht polyneuropathy, inadequate co-operation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oulu University Hospital
Oulu, 90029, Finland
Related Publications (1)
Kortekangas T, Savola O, Flinkkila T, Lepojarvi S, Nortunen S, Ohtonen P, Katisko J, Pakarinen H. A prospective randomised study comparing TightRope and syndesmotic screw fixation for accuracy and maintenance of syndesmotic reduction assessed with bilateral computed tomography. Injury. 2015;46(6):1119-26. doi: 10.1016/j.injury.2015.02.004. Epub 2015 Feb 21.
PMID: 25769201DERIVED
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Tero HJ Kortekangas, MD
Oulu University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
June 12, 2012
First Posted
December 5, 2012
Study Start
July 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
May 16, 2016
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will not share