Ankle Fracture, Postoperative Treatment
Conditions
Brief summary
The goal of this randomized clinical trial was to compare the effect of 6-week casting versus 2-week casting followed by 4-week ankle bracing in adult patients with surgically treated ankle fractures. The primary outcome measures used were the functional results 3 months after surgery evaluated using two functional outcome measures (Olerud and Molander score and Kaikkonen score) and the patient return to work. In the casting group, the traditional plaster was changed to a fiberglass one at 2 weeks and the cast treatment continued until 6 weeks. In the functional treatment group, the traditional plaster cast was changed to an reusable semi-rigid plastic orthosis (Aircast) at 2 weeks after surgery and its use was continued as an ankle support for up to 6 weeks. Follow-ups including subjective and objective evaluations were at 2, 6, 12 and 52 weeks and at 2 years postoperatively.
Interventions
DEVICE2-week casting followed by 4-week bracing
Participants in the bracing group had a cast for 2 weeks after the surgery followed by ankle brace for 4 weeks.
DEVICE6-week casting
Participants in the casting group had a cast for 6 weeks after the surgery.
Sponsors
Tampere University Hospital
Töölö Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Weber A or B type ankle fracture * uni-, bi- or trimalleolar injury and/or fibular displacement of \>2 mm in any plane on the radiographs
Exclusion criteria
* Weber C injury necessitating syndesmotic fixation * Pilon injury * Inadequate co-operation * Other severe concomitant injuries
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Olerud-Molander score | 3 months and 24 months | Patient-reported outcome measure, 0-100 points, higher points indicating better result. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ankle active plantarflexion | 6 weeks, 3, 12, and 24 months | Degrees compared to unaffected side |
| Return-to-work | Within 24 months | Days after the injury |
| Olerud-Molander score | 6 weeks and 12 months | Patient-reported outcome measure, 0-100 points, higher points indicating better result. |
| Kaikkonen score | 6 weeks, 3, 12, and 24 months | Patient-reported outcome measure, 0-100 points, higher points indicating better result. |
| Swelling of the ankle | 6 weeks, 3, 12, and 24 months | Circumference in millimetres compared to unaffected side |
| Atrophy of the calf muscles | 6 weeks, 3, 12, and 24 months | Circumference in millimetres compared to unaffected side |
| Ankle active dorsiflexion | 6 weeks, 3, 12, and 24 months | Degrees compared to unaffected side |
| Subjective symptoms and return to activities | 2 and 6 weeks; 3, 12, and 24 months | The patients were questioned about the subjective symptoms (pain, swelling, stiffness and giving way) and about the compliance of using the cast or brace. In addition the patients were asked about the length of their inability to work and participate in the daily activities and/or sports at the preinjury level. |
| Visual Analog Scale for Pain | 6 weeks, 3, 12, and 24 months | 0-10, higher score indicating more pain. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Complications | 2 and 6 weeks; 3, 12, and 24 months | Infection, loss of reduction, implant loosening, deep vein thrombosis |
Outcome results
None listed