Tightrope or Screw Fixation of Acute Tibiofibular Syndesmotic Injury (TIGHTROPE-SS)

April 17, 2018 updated by: Wender Figved, Sykehuset Asker og Baerum

Tightrope or Screw Fixation of Acute Tibiofibular Syndesmotic Injury. Randomised Controlled Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients 18-70 years presenting to one of the two hospitals with an acute syndesmotic injury are eligible for inclusion. 50 patients are randomised to two treatment groups: One group receives a Tightrope (R) fixation and the other receives a quadricortical screw fixation which is removed after 12 weeks. Follow-up intervals are at 6 weeks, 6, 12 and 24 months with standardised CT scans postoperatively and at 12, 24 months and 5 years clinical end-ponts/scores.

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0407
        • Oslo University Hospital
      • Rud, Norway, 1351
        • Baerum Hospital, Vestre Viken

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 to 70 years
  • Acute syndesmotic injury with or without Weber type C fracture

Exclusion Criteria:

  • Prior injury of the same ankle
  • Severe injury of same leg affecting rehabilitation
  • Symptomatic osteoarthritis of same ankle
  • Open injury
  • Decubital injury affecting surgical site
  • Dementia or unable to sign informed consent
  • Neuropathic conditions affecting same leg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tightrope
Treatment with Tightrope Syndesmosis Repair Kit
Device: Tightrope Syndesmosis Repair Kit
Tightrope Syndesmosis Repair Kit
Other Names:
  • Tightrope Syndesmosis Repair Kit, Arthrex; Naples, Florida
Active Comparator: Syndesmotic screw
Treatment with a quadricortical syndesmotic screw
Device: Syndesmotic screw
Quadricortical syndesmotic screw
Other Names:
  • Cortical screw; Synthes GmbH, Switzerland

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OTA Score (Modified American Orthopaedic Foot and Ankle Society ankle hind foot score)
Time Frame: 5 years
Modified American Orthopaedic Foot and Ankle Society ankle hind foot score (0-100)
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Olerud-Molander Ankle (OMA) Score
Time Frame: 5 years
5 years
Dorsiflexion angle
Time Frame: 5 years
According to Lindsjø
5 years
Health-related quality of life (EQ-5D)
Time Frame: 5 years
5 years
CT measurements of syndesmotic distance
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sykehuset Asker og Baerum

Collaborators

Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

January 11, 2011

First Submitted That Met QC Criteria

January 12, 2011

First Posted (Estimate)

January 13, 2011

Study Record Updates

Last Update Posted (Actual)

April 18, 2018

Last Update Submitted That Met QC Criteria

April 17, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TIGHTROPE-SS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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