Routine Versus on Demand Removal of the Syndesmotic Screw

Anke Fracture Clinical Trial

— RODEO  

Official title:

Routine Versus on Demand Removal of the Syndesmotic Screw

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02896998
• Other study ID #: METC2016_197
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: May 1, 2020

Study information

• Verified date: July 2020
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anke Fracture
• Ankle Injuries
• Syndesmotic Injury

Intervention

Procedure:
• Removal on demand of the syndesmotic screw
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 screw
The syndesmotic screw will routinely be removed 8 - 12 weeks following placement of the screw

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional outcome through the Olerud-Moland score		1 year following initial treatment
Secondary	Functional outcome through the OAFAS		1 year following initial treatment
Secondary	Pain through the Visual Analog scale		1 year following initial treatment
Secondary	Range of motion		1 year following initial treatment
Secondary	Surgical complications		1 year following initial treatment
Secondary	Quality of Life through the EQ-5D-5L		1 year following initial treatment
Secondary	Health care consumption through the iMCQ		1 year following initial treatment
Secondary	Loss of productivity through the iPCQ		1 year following initial treatment