Ziptight or Tricortical Screw Fixation of Acute Tibiofibular Syndesmotic Injury (S16)

November 26, 2019 updated by: Vestre Viken Hospital Trust
Treatment of syndesmotic injury with Weber C fracture. A randomized study comparing ZipTight suture endobutton and one tricortical 3,5 mm syndesmotic screw.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 ZipTight suture endobutton (Biomet) is used for the same indication. It does not need removal and thus avoids subsequent surgery. This trial will compare these two methods and see if they are equal.

patients 18-70 years presenting to one of the three hospitals with and acute syndesmotic injury are eligible for inclusion. 120 patients are randomized to two treatment groups. One group will be treated with a ZipTight suture endobutton fixation and the other receives a tricortical screw fixation. Neither suture endobutton or screw is routinely removed. Follow up intervals are at 6 weeks, 6, 12 and 24 months with clinical and-points. Standardized CT scans are taken postoperatively and at 12 and 24 months.

Study Type

Interventional

Enrollment (Actual)

120

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
    • Gjettum
      • Sandvika, Gjettum, Norway, 1346
        • 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

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 to 70 years
  • Acute syndesmotic injury with Weber type C fracture

Exclusion Criteria:

  • Prior injury og the same ankle
  • Severe injury of the same leg affecting rehabilitation
  • Symptomatic osteoarthritis of same ankle
  • open injury
  • Decubital injury affecting surgical site
  • Dementia or unable to sign informed consent
  • neuropatic 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: ZipTight
ZipTight suture endobutton
Device: ZipTight suture endobutton
Zimmer Biomet ZipTight suture endobutton
Active Comparator: Syndesmotic screw
Tricortical 3.5 mm syndesmotic screw
Device: Tricortical 3.5 mm syndesmotic screw
Depuy Synthes 3.5 mm screw

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: 24 months
Modified American Orthopaedic Foot and Ankle Society ankle hind foot score (0-100)
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Manchester-Oxford Foot questionnaire (MOxFQ)
Time Frame: 24 months
24 months
Dorsiflexion angle
Time Frame: 24 months
according to Lindsjø
24 months
Health-related quality of life (EQ-5D)
Time Frame: 24 months
24 months
CT measurements of syndesmotic distance
Time Frame: 24 months
24 months
VAS
Time Frame: 24 months
visual analogue scale
24 months

Collaborators and Investigators

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

Sponsor

Vestre Viken Hospital Trust

Collaborators

Oslo University Hospital
Ostfold Hospital Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2016

Primary Completion (Actual)

September 30, 2017

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

April 18, 2016

First Submitted That Met QC Criteria

October 9, 2016

First Posted (Estimate)

October 12, 2016

Study Record Updates

Last Update Posted (Actual)

November 29, 2019

Last Update Submitted That Met QC Criteria

November 26, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Syndesmose2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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