Routine Versus on Demand Removal of the Syndesmotic Screw (RODEO)

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

Status: Completed

Conditions: Anke Fracture; Syndesmotic Injury

Treatments: Procedure: Removal on demand of the syndesmotic screw; Procedure: Routine removal of fhe syndesmotic screw

Study type: Interventional

Funder types: Other

Identifiers

NCT02896998

METC2016_197

Details and patient eligibility

About

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.

Enrollment: 197 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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197 participants in 2 patient groups

Control group

Other group

Description:

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

Treatment:

Procedure: Routine removal of fhe syndesmotic screw

Intervention

Experimental group

Description:

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

Treatment:

Procedure: Removal on demand of the syndesmotic screw