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Ankle Syndesmosis Fixation by Antibiotic Releasing Bioabsorbable Screw

NCT01729195 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2014-02-17

No results posted yet for this study

Summary

This single-center randomized trial evaluates the efficacy and safety of a new bone screw (antibiotic releasing bioabsorbable screw) in fixation of syndesmosis in patients with Weber C-type ankle fractures. The comparison is made to subjects treated by conventional metal screw fixation of the syndesmosis. The primary objective is to show that the antibiotic releasing bioabsorbable screw is at least as good as the routinely used metal screw in prevention of syndesmosis widening in patients with Weber C-type ankle fractures. The secondary objective is to show that the clinical outcome of the ankle fracture treatment is equal between patients treated by the antibiotic releasing bioabsorbable screw and the conventional metal screw.

Conditions

  • Ankle Fracture

Interventions

PROCEDURE

A ciprofloxacin containing bioabsorbable PLGA bone screw

The syndesmosis injury will be fixed the antibiotic releasing bioabsorbable bone screw or a standard metal screw. After surgery, the ankle will be immobilized in a cast for 6 weeks. The metal screw will be surgically removed at 8 weeks. The bioabsorbable screw will be left in place.

Sponsors & Collaborators

  • Tampere University of Technology

    collaborator OTHER

  • Turku University Hospital

    lead OTHER_GOV

Principal Investigators

  • Hannu T Aro, MD, PhD · Turku University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2008-01-31
Completion
2014-01-31

Countries

  • Finland

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 NCT01729195 on ClinicalTrials.gov