Not provided
Not provided
Not provided
Not provided
Not provided
Partly due to financial issues and changes in study staff work placements
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A one third of all ankle fractures are bi- or trimalleolar. Traditionally these fractures are treated by both medial and lateral osteosynthesis, sometimes accompanied by osteosynthesis of the posterior malleolus. There is significant evidence that fractures of the lateral malleolus can be treated conservatively if the medial side is stable. However, there isn't a single study comparing standard bi- or trimalleolar fixation with only medial side osteosynthesis and postoperative immobilization with a cast.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unimalleolar Fixation | Experimental | Medial malleolus is fixed first and after that ankle mortise stability is assessed using external-rotation stress test. If talocrural joint is stable after fixation of medial malleolus, the patient is randomized to unimalleolar fixation group and no fixation of the lateral side is performed. |
|
| Bimalleolar Fixation | Active Comparator | Medial malleolus is fixed first and after that ankle mortise stability is assessed using external-rotation stress test. If talocrural joint is stable after fixation of medial malleolus, the patient is randomized to bimalleolar fixation group i.e. additional fixation of the lateral malleolus fracture is performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unimalleolar fixation | Procedure | Medial malleolus is fixed first and after that ankle mortise stability is assessed using external-rotation stress test. If talocrural joint is stable after fixation of medial malleolus, the patient is randomized to unimalleolar fixation group and no fixation of the lateral side is performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Olerud-Molander Ankle Score | A validated, condition-specific, patient-reported measure of ankle fracture symptoms. Range from 0 to 100 points, with higher scores indicating better function | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| The Foot and Ankle Outcome Score (FAOS) | FAOS, 5 subscales from 0-100, with higher scores indicating better function | 2 years |
| A 100 mm Visual Analogue Scale for function and pain (VAS) | Range from 0 to 100, with higher scores indicating more severe pain |
| Measure | Description | Time Frame |
|---|---|---|
| Complications and Harms | Treatment related complications and harms (i.e. wound infection, re-operations, deep vein trombhosis, plaster sore, wound healing problems) | At two, four and 12 weeks, and at 2 years |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Harri J Pakarinen, MD, PhD, AP | Pohjois-Pohjanmaan sairaanhoitopiiri | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oulu University Hospital | Oulu | 90029 | Finland |
Not provided
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Bimalleolar fixation | Procedure | Medial malleolus is fixed first and after that ankle mortise stability is assessed using external-rotation stress test. If talocrural joint is stable after fixation of medial malleolus, the patient is randomized to bimalleolar fixation group i.e. additional fixation of the lateral malleolus fracture is performed. |
|
| 2 years |
| The RAND 36-Item Health Survey for health-related quality-of-life (RAND-36) | 8 subscales from 0-100, with higher scores indicating better health-related quality of life | 2 years |
| Talocrural joint congruence | Medial clear space < 4 mm and ≤ 1 mm wider than the superior clear space as measured between the lateral border of the medial malleolus and the medial border of the talus at the level of the talar dome. | At two, four and 12 weeks, and at 2 years |
| Fracture healing | Fracture union is considered complete when the fracture line disappeared and conversely, those fractures with a visible fracture line are deemed non-unions. | 2 years |