Ankle Fractures
Conditions
Keywords
Syndesmosis, Injury, Ankle, Fracture, Weber C
Brief summary
Treatment of syndesmotic injury with Weber C fracture. A randomized study comparing ZipTight suture endobutton and one tricortical 3,5 mm syndesmotic screw.
Detailed description
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.
Interventions
DEVICEZipTight suture endobutton
Zimmer Biomet ZipTight suture endobutton
DEVICETricortical 3.5 mm syndesmotic screw
Depuy Synthes 3.5 mm screw
Sponsors
Oslo University Hospital
Ostfold Hospital Trust
Vestre Viken Hospital Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 70 years * Acute syndesmotic injury with Weber type C fracture
Exclusion criteria
* Prior injury og the same ankle * Severe injury of the same leg affecting rehabilitation * Symptomatic osteoarthritis of same ankle * open injury * Decubital injury affecting surgical site * Dementia or unable to sign informed consent * neuropatic conditions affecting same leg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OTA Score (Modified American Orthopaedic Foot and Ankle Society ankle hind foot score) | 24 months | Modified American Orthopaedic Foot and Ankle Society ankle hind foot score (0-100) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Manchester-Oxford Foot questionnaire (MOxFQ) | 24 months | — |
| Dorsiflexion angle | 24 months | according to Lindsjø |
| Health-related quality of life (EQ-5D) | 24 months | — |
| CT measurements of syndesmotic distance | 24 months | — |
| VAS | 24 months | visual analogue scale |
Countries
Norway
Outcome results
None listed