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

NCT05729542 | Recruiting FDA Device

• 1 other identifier: 800669
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Syndesmotic Injuries; Ankle Fractures; Ankle Injuries

Outcome Measures

Primary Outcomes (3)

• Visual Analog Scale (VAS) Pain score

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

  1 year

• Foot and Ankle Disability Index

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

  1 year

• Olerud-Molander Ankle Score

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

  1 year

Secondary Outcomes (1)

• Number of participants with medical or surgical complications

  1 year

Study Arms (2)

Arthrex Tightrope

ACTIVE COMPARATOR

Syndesmosis fixation performed with ARthrex Tightrope device. This is a high-tension suture fixation with a button based anchor system.

Device: Arthrex Tightrope

Synthes Fibulink

EXPERIMENTAL

Syndesmosis fixation perforemd with Synthes Fibulink device. This is a high-tension fixation with a screw based anchor system.

Device: Synthes Fibulink

Interventions

Arthrex Tightrope DEVICE

High-tensile strength suture syndesmosis repair

Arthrex Tightrope

Synthes Fibulink DEVICE

High-tensile strength suture syndesmosis repair

Synthes Fibulink

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

San Diego, California, 92093, United States

RECRUITING

MeSH Terms

Conditions

Ankle Injuries; Ankle Fractures

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Fractures, Bone

Central Study Contacts

Dominic Baun, MS

CONTACT

858-534-8268; jbaun@health.ucsd.edu

William Kent, MD

CONTACT

619-543-2694; wkent@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopaedic Surgery

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 15, 2023
• Study Start: November 18, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)