Routine Versus on Demand Removal of the Syndesmotic Screw

Not Applicable

Completed

• Conditions: Anke Fracture; Syndesmotic Injury

• Registration Number: NCT02896998
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-07
• Study First Submitted QC: 2016-09-07
• Study First Posted: 2016-09-12
• Study Start: 2017-01
• Primary Completion: 2020-05-01
• Study Completion: 2020-05-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-08
• Last Update Posted: 2020-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Functional outcome through the Olerud-Moland score	1 year following initial treatment

Secondary Outcome Measures

Name	Time	Method
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
Functional outcome through the OAFAS	1 year following initial treatment

Trial Locations

Locations (1)

Academic Medical Center; 🇳🇱 Amsterdam, Noord-Holland, Netherlands