Skip to main content
OpenTrials
Completed

NCT Number: NCT02930486

Ziptight or Tricortical Screw Fixation of Acute Tibiofibular Syndesmotic Injury

Treatment of syndesmotic injury with Weber C fracture. A randomized study comparing ZipTight suture endobutton and one tricortical 3,5 mm syndesmotic screw.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ankle Fractures Ankle Injuries Fractures, Bone Leg Injuries Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baerum Hospital, Vestre Viken

Sandvika, Gjettum, 1346, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ZipTight suture endobutton

Device

Zimmer Biomet ZipTight suture endobutton

Tricortical 3.5 mm syndesmotic screw

Device

Depuy Synthes 3.5 mm screw

Primary outcomes

  1. 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)

Secondary outcomes

  1. Manchester-Oxford Foot questionnaire (MOxFQ)

    Time frame: 24 months

  2. Dorsiflexion angle

    Time frame: 24 months

    according to Lindsjø

  3. Health-related quality of life (EQ-5D)

    Time frame: 24 months

  4. CT measurements of syndesmotic distance

    Time frame: 24 months

  5. VAS

    Time frame: 24 months

    visual analogue scale

Sponsors and collaborators

Lead sponsor

Vestre Viken Hospital Trust

Other

Collaborators

  • Oslo University Hospital
  • Ostfold Hospital Trust

Registry information

Acronym: S16

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Oct 12, 2016
Registry last updated
Nov 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.