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| Name | Class |
|---|---|
| Oslo University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tightrope | Active Comparator | Treatment with Tightrope Syndesmosis Repair Kit |
|
| Syndesmotic screw | Active Comparator | Treatment with a quadricortical syndesmotic screw |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tightrope Syndesmosis Repair Kit | Device | Tightrope Syndesmosis Repair Kit |
|
| Measure | Description | Time Frame |
|---|---|---|
| OTA Score (Modified American Orthopaedic Foot and Ankle Society ankle hind foot score) | Modified American Orthopaedic Foot and Ankle Society ankle hind foot score (0-100) | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Olerud-Molander Ankle (OMA) Score | 5 years | |
| Dorsiflexion angle | According to Lindsjø | 5 years |
| Health-related quality of life (EQ-5D) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wender Figved, MD, PhD | Baerum Hospital, Vestre Viken, Norway | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | 0407 | Norway | |||
| Baerum Hospital, Vestre Viken |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| Syndesmotic screw | Device | Quadricortical syndesmotic screw |
|
|
| 5 years |
| CT measurements of syndesmotic distance | 5 years |
| Rud |
| 1351 |
| Norway |