Routine Versus on Demand Removal of the Syndesmotic Screw

Not Applicable

Completed

• Conditions: Anke Fracture; Syndesmotic Injury
• Interventions: Procedure: Routine removal of fhe syndesmotic screw; Procedure: Removal on demand of the syndesmotic screw

• 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

Arm && Interventions

Group	Intervention	Description
Control group	Routine removal of fhe syndesmotic screw	The syndesmotic screw will routinely be removed 8 - 12 weeks following placement of the screw
Intervention	Removal on demand of the syndesmotic screw	The syndesmotic screw will only be removed in case of symptomatic implants (e.g. implants causing pain or restricted range of motion)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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