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Routine Versus on Demand Removal of the Syndesmotic Screw

NCT02896998 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 197

Last updated 2020-07-10

No results posted yet for this study

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.

Conditions

  • Anke Fracture
  • Syndesmotic Injury

Interventions

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)

PROCEDURE

Routine removal of fhe syndesmotic screw

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

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2020-05-01
Completion
2020-05-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02896998 on ClinicalTrials.gov