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The objective of this trial is to demonstrate that the functional outcome of 'removal on demand' of the syndesmotic screw is non-inferior compared to routine removal of the syndesmotic screw in patients with an ankle fracture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Other | The syndesmotic screw will routinely be removed 8 - 12 weeks following placement of the screw |
|
| Intervention | Experimental | The syndesmotic screw will only be removed in case of symptomatic implants (e.g. implants causing pain or restricted range of motion) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Removal on demand of the syndesmotic screw | Procedure | The syndesmotic screw will only be removed in case of a symptomatic implant (e.g. implant causing pain or restricted range of motion) |
| Measure | Description | Time Frame |
|---|---|---|
| Functional outcome through the Olerud-Moland score | 1 year following initial treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Functional outcome through the OAFAS | 1 year following initial treatment | |
| Pain through the Visual Analog scale | 1 year following initial treatment | |
| Range of motion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Medical Center | Amsterdam | North Holland | 1105AZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29386053 | Derived | Dingemans SA, Birnie MFN, Sanders FRK, van den Bekerom MPJ, Backes M, van Beeck E, Bloemers FW, van Dijkman B, Flikweert E, Haverkamp D, Holtslag HR, Hoogendoorn JM, Joosse P, Parkkinen M, Roukema G, Sosef N, Twigt BA, van Veen RN, van der Veen AH, Vermeulen J, Winkelhagen J, van der Zwaard BC, van Dieren S, Goslings JC, Schepers T. Routine versus on demand removal of the syndesmotic screw; a protocol for an international randomised controlled trial (RODEO-trial). BMC Musculoskelet Disord. 2018 Jan 31;19(1):35. doi: 10.1186/s12891-018-1946-5. |
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| ID | Term |
|---|---|
| D016512 | Ankle Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| Routine removal of fhe syndesmotic screw | Procedure | The syndesmotic screw will routinely be removed 8 - 12 weeks following placement of the screw |
|
| 1 year following initial treatment |
| Surgical complications | 1 year following initial treatment |
| Quality of Life through the EQ-5D-5L | 1 year following initial treatment |
| Health care consumption through the iMCQ | 1 year following initial treatment |
| Loss of productivity through the iPCQ | 1 year following initial treatment |