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| Name | Class |
|---|---|
| Oslo University Hospital | OTHER |
| Ostfold Hospital Trust | OTHER |
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Treatment of syndesmotic injury with Weber C fracture. A randomized study comparing ZipTight suture endobutton and one tricortical 3,5 mm syndesmotic screw.
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 ZipTight suture endobutton (Biomet) is used for the same indication. It does not need removal and thus avoids subsequent surgery. This trial will compare these two methods and see if they are equal.
patients 18-70 years presenting to one of the three hospitals with and acute syndesmotic injury are eligible for inclusion. 120 patients are randomized to two treatment groups. One group will be treated with a ZipTight suture endobutton fixation and the other receives a tricortical screw fixation. Neither suture endobutton or screw is routinely removed. Follow up intervals are at 6 weeks, 6, 12 and 24 months with clinical and-points. Standardized CT scans are taken postoperatively and at 12 and 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZipTight | Active Comparator | ZipTight suture endobutton |
|
| Syndesmotic screw | Active Comparator | Tricortical 3.5 mm syndesmotic screw |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZipTight suture endobutton | Device | Zimmer Biomet ZipTight suture endobutton |
| |
| 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) | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Manchester-Oxford Foot questionnaire (MOxFQ) | 24 months | |
| Dorsiflexion angle | according to Lindsjø | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baerum Hospital, Vestre Viken | Sandvika | Gjettum | 1346 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32907456 | Derived | Raeder BW, Stake IK, Madsen JE, Frihagen F, Jacobsen SB, Andersen MR, Figved W. Randomized trial comparing suture button with single 3.5 mm syndesmotic screw for ankle syndesmosis injury: similar results at 2 years. Acta Orthop. 2020 Dec;91(6):770-775. doi: 10.1080/17453674.2020.1818175. Epub 2020 Sep 10. |
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| ID | Term |
|---|---|
| D064386 | Ankle Fractures |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D016512 | Ankle Injuries |
| D007869 | Leg Injuries |
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| Tricortical 3.5 mm syndesmotic screw |
| Device |
Depuy Synthes 3.5 mm screw |
|
| Health-related quality of life (EQ-5D) |
| 24 months |
| CT measurements of syndesmotic distance | 24 months |
| VAS | visual analogue scale | 24 months |