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Tightrope or Screw Fixation of Acute Tibiofibular Syndesmotic Injury

NCT01275924 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2018-04-18

No results posted yet for this study

Summary

Syndesmotic injuries are common and often associated with unstable ankle fractures. The most common treatment is with a syndesmotic screw through the fibula and tibia which is later removed, usually after 10-12 weeks. The Tightrope Syndesmosis Repair Kit (Arthrex; Naples, Florida). is used for the same indication, it consists of a heavy suture placed across the syndesmosis which has been looped and tightened through cortical button anchors on either side of the ankle. It does not need removal and thus avoids subsequent surgery. This trial compares these two treatment methods for syndesmotic injuries of the ankle.

Conditions

  • Syndesmotic Injury of the Ankle

Interventions

DEVICE

Tightrope Syndesmosis Repair Kit

Tightrope Syndesmosis Repair Kit

DEVICE

Syndesmotic screw

Quadricortical syndesmotic screw

Sponsors & Collaborators

  • Oslo University Hospital

    collaborator OTHER

  • Sykehuset Asker og Baerum

    lead OTHER

Principal Investigators

  • Wender Figved, MD, PhD · Baerum Hospital, Vestre Viken, Norway

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2015-03-31
Completion
2018-04-30

Countries

  • Norway

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 NCT01275924 on ClinicalTrials.gov