Routine Versus on Demand Removal of the Syndesmotic Screw

Study Overview
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Brief Summary
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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.

Official Title
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Routine Versus on Demand Removal of the Syndesmotic Screw

Conditions
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Anke Fracture, Syndesmotic Injury

Intervention / Treatment
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* Procedure: Removal on demand of the syndesmotic screw
* Procedure: Routine removal of fhe syndesmotic screw


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 17 years of age Placement of a metallic syndesmotic screw for an unstable ankle fracture or an isolated syndesmotic injury Syndesmotic screw placed within two weeks of the trauma Being in such condition that one is able to possibly undergo a second procedure Exclusion Criteria: ISS score >15 Injuries to the ipsi- and contralateral side which might hamper rehabilitation Other medical conditions which hamper physical rehabilitation Incomprehensive understanding of the Dutch language

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control group<br>The syndesmotic screw will routinely be removed 8 - 12 weeks following placement of the screw | Procedure: Routine removal of fhe syndesmotic screw<br>* The syndesmotic screw will routinely be removed 8 - 12 weeks following placement of the screw<br>|
| Experimental: Intervention<br>The syndesmotic screw will only be removed in case of symptomatic implants (e.g. implants causing pain or restricted range of motion) | Procedure: Removal on demand of the syndesmotic screw<br>* The syndesmotic screw will only be removed in case of a symptomatic implant (e.g. implant causing pain or restricted range of motion)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcome through the Olerud-Moland score |  | 1 year following initial treatment | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |