Routine Versus on Demand Removal of the Syndesmotic Screw

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)197 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

197

Conditions

Anke Fracture Syndesmotic Injury

Interventions

Removal on demand of the syndesmotic screwPROCEDURE

The syndesmotic screw will only be removed in case of a symptomatic implant (e.g. implant causing pain or restricted range of motion)

Routine removal of fhe syndesmotic screwPROCEDURE

The syndesmotic screw will routinely be removed 8 - 12 weeks following placement of the screw

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Academic Medical Center

Amsterdam, North Holland, Netherlands