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NCT Number: NCT05729542

Comparing Clinical Outcomes of Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries

This project consists of a randomized controlled study design. Study candidates will include all patients 18 years or older, who were evaluated at UCSD and found to have an acute ankle syndesmosis injury requiring surgery. Patients who consent to study participation will be randomized to receive one of two standard of care procedures - either a suture button or Fibulink implant. Outcome measures, including the Olerud-Molander and American Orthopaedic Foot and Ankle Society scores, pain, range of motion, time to return to work, and radiographic evaluation will be collected for each participant. Given the potential degenerative changes and poor radiographic and clinical outcomes with inadequate repair of the syndesmosis, it is imperative to evaluate existing and emerging methods of fixation for patients with acute ankle fractures with syndesmosis injuries.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego

San Diego, California, 92093, United States

Location status: Recruiting

Location contact

Dominic Baun, MS

CONTACT

[email protected]

858-534-8268

William Kent, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Ankle fracture with associated syndesmotic injury requiring surgery
  • Age 18 years or older
  • Ability to understand the content of the patient information/informed consent form

Exclusion criteria

  • Any not medically managed severe systemic disease
  • Patient preference for specific implant
  • Refusal of randomization
  • Pregnant patients
  • Prisoners
  • Participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study

Treatment and study plan

Arthrex Tightrope

Device

High-tensile strength suture syndesmosis repair

Synthes Fibulink

Device

High-tensile strength suture syndesmosis repair

Primary outcomes

  1. Visual Analog Scale (VAS) Pain score

    Time frame: 1 year

    VAS Pain score is rated from 0-10, 0=no pain and 10=most severe pain

  2. Foot and Ankle Disability Index

    Time frame: 1 year

    Functional score with a 0-104 with higher scores indicating better function

  3. Olerud-Molander Ankle Score

    Time frame: 1 year

    Functional Score with a score of 0-100 with higher scores indicating better function

Secondary outcomes

  1. Number of participants with medical or surgical complications

    Time frame: 1 year

    Medical and surgical complications to include: surgical site infection, re-operation, device failure, loss of motion

Study contacts

Contact information is provided by the study sponsor or research team.

Dominic Baun, MS

CONTACT

[email protected]

858-534-8268

William Kent, MD

CONTACT

[email protected]

619-543-2694

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

Randomized Controlled Trial Comparing Clinical Outcomes of Patients Treated Surgically With Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Feb 15, 2023
Registry last updated
Feb 10, 2026

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.

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