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Screw Versus Tightrope Syndesmotic Injury Fixation in Weber C Ankle Fractures

Screw Versus Tightrope Syndesmotic Injury Fixation in Weber C Ankle Fractures. A Prospective Randomized Study.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01742650
Enrollment
38
Registered
2012-12-05
Start date
2010-07-31
Completion date
2011-12-31
Last updated
2016-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trauma

Keywords

ankle; fracture; syndesmosis;

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.

Detailed description

The aim of our study is to compare two different syndesmosis transfixation methods in AO/OTA Weber C ankle fractures. Screw fixation is widely and mostly used transfixation but suture-button is also shown to be a biomechanically stable and probably more physiologic transfication method. It is shown that even 50 % of the syndesmosis srews and thus fibulas are in malposition. With more physiologic suture-button transfixation this malposition is thought to be less commmon. There is no studies comparing screw and suture-button syndesmosis transfixation methods in AO/OTA Weber C ankle fracture patients. Our hypothesis is that 50% of screw fixed fibulas but only 5% of suture-button fixed fibulas are in malposition assessed in the intraoperative computed tomography. Malposition is assessed to present if difference between fractured and non-fractured side is at least 2 mm in the tibiofibular joint. Thus, the sample size is assessed to be 19 patients per group (alpha=0.05, Beta=0.2, 20% drop out). All skeletally mature patients (16 years or older) with AO/OTA Weber C type fractures operated within a week after trauma are included into the study. Exclusion criteria are previous ankle fracture, concomitant tibial fracture, diabetes with peripheral neuropathy, pathological fracture or inadequate co-operation. After bony fixation the tibiofibular transfixation is randomly performed either by a 3,5 mm tricortical screw or a suture-button (TightRope). An intraoperative computed tomography is imaged from the both ankles of all patients. The operation is continued with six weeks casting without weight-bearing. Clinical outcome was assessed using the Olerud-Molander scoring system, RAND 36-Item Health Survey, and Visual Analogue Scale (VAS) to measure pain and function after a minimum 1-year of follow-up.

Interventions

3,5mm fully threaded cortical screw transfixation of syndesmosis

PROCEDURETightRope

TightRope transfixation of syndesmosis

Sponsors

University of Oulu
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* AO/OTA Weber C ankle fracture, operation within 7 days from the injury

Exclusion criteria

* Bilateral or previous ankle fracture, tibial shaft fracture, diabetes wiht polyneuropathy, inadequate co-operation

Design outcomes

Primary

MeasureTime frameDescription
Malreduction of the tibiofibular joint in the intraoperative computed tomography2 yearsMalreduction 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

Secondary

MeasureTime frameDescription
Clinical outcome one year after the injury2 yearClinical outcome was assessed using the Olerud-Molander scoring system, RAND 36-Item Health Survey, and Visual Analogue Scale (VAS) to measure pain and function after a minimum 2-year of follow-up.

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026