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

A

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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