Syndesmotic Injury of the Ankle
Conditions
Keywords
Syndesmosis, Injury, Ankle, Fracture
Brief summary
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 Tightrope Syndesmosis Repair Kit (Arthrex; Naples, Florida). is used for the same indication, it consists of a heavy suture placed across the syndesmosis which has been looped and tightened through cortical button anchors on either side of the ankle. It does not need removal and thus avoids subsequent surgery. This trial compares these two treatment methods for syndesmotic injuries of the ankle.
Detailed description
Patients 18-70 years presenting to one of the two hospitals with an acute syndesmotic injury are eligible for inclusion. 50 patients are randomised to two treatment groups: One group receives a Tightrope (R) fixation and the other receives a quadricortical screw fixation which is removed after 12 weeks. Follow-up intervals are at 6 weeks, 6, 12 and 24 months with standardised CT scans postoperatively and at 12, 24 months and 5 years clinical end-ponts/scores.
Interventions
DEVICETightrope Syndesmosis Repair Kit
Tightrope Syndesmosis Repair Kit
DEVICESyndesmotic screw
Quadricortical syndesmotic screw
Sponsors
Oslo University Hospital
Sykehuset Asker og Baerum
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 or without Weber type C fracture
Exclusion criteria
* Prior injury of the same ankle * Severe injury of same leg affecting rehabilitation * Symptomatic osteoarthritis of same ankle * Open injury * Decubital injury affecting surgical site * Dementia or unable to sign informed consent * Neuropathic conditions affecting same leg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OTA Score (Modified American Orthopaedic Foot and Ankle Society ankle hind foot score) | 5 years | Modified American Orthopaedic Foot and Ankle Society ankle hind foot score (0-100) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Olerud-Molander Ankle (OMA) Score | 5 years | — |
| Dorsiflexion angle | 5 years | According to Lindsjø |
| Health-related quality of life (EQ-5D) | 5 years | — |
| CT measurements of syndesmotic distance | 5 years | — |
Countries
Norway
Outcome results
None listed