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| Name | Class |
|---|---|
| Tampere University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bracing group | Experimental | Participants in the bracing group had a cast for 2 weeks after the surgery followed by ankle brace for 4 weeks. |
|
| Casting group | Active Comparator | Participants in the casting group had a cast for 6 weeks after the surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2-week casting followed by 4-week bracing | Device | Participants in the bracing group had a cast for 2 weeks after the surgery followed by ankle brace for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Olerud-Molander score | Patient-reported outcome measure, 0-100 points, higher points indicating better result. | 3 months and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Olerud-Molander score | Patient-reported outcome measure, 0-100 points, higher points indicating better result. | 6 weeks and 12 months |
| Kaikkonen score | Patient-reported outcome measure, 0-100 points, higher points indicating better result. |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Infection, loss of reduction, implant loosening, deep vein thrombosis | 2 and 6 weeks; 3, 12, and 24 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Teppo Järvinen, Prof | Helsinki University Central Hospital | Study Chair |
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| ID | Term |
|---|---|
| D064386 | Ankle Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D016512 | Ankle Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| D001915 | Braces |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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Randomized controlled trial
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| 6-week casting | Device | Participants in the casting group had a cast for 6 weeks after the surgery. |
|
| 6 weeks, 3, 12, and 24 months |
| Visual Analog Scale for Pain | 0-10, higher score indicating more pain. | 6 weeks, 3, 12, and 24 months |
| Swelling of the ankle | Circumference in millimetres compared to unaffected side | 6 weeks, 3, 12, and 24 months |
| Atrophy of the calf muscles | Circumference in millimetres compared to unaffected side | 6 weeks, 3, 12, and 24 months |
| Ankle active dorsiflexion | Degrees compared to unaffected side | 6 weeks, 3, 12, and 24 months |
| Ankle active plantarflexion | Degrees compared to unaffected side | 6 weeks, 3, 12, and 24 months |
| Return-to-work | Days after the injury | Within 24 months |
| Subjective symptoms and return to activities | 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. | 2 and 6 weeks; 3, 12, and 24 months |