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

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Diego
Study ID
NCT05729542
Status
Recruiting
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Conditions

  • Ankle Fractures
  • Ankle Injuries
  • Syndesmotic Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Arthrex Tightrope — DEVICE
    High-tensile strength suture syndesmosis repair
  • Synthes Fibulink — DEVICE
    High-tensile strength suture syndesmosis repair

Study Details

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.

Key Dates

Start date
Nov 18, 2021
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arthrex Tightrope
    Syndesmosis fixation performed with ARthrex Tightrope device. This is a high-tension suture fixation with a button based anchor system.
  • Experimental: Synthes Fibulink
    Syndesmosis fixation perforemd with Synthes Fibulink device. This is a high-tension fixation with a screw based anchor system.

Primary Outcome Measure

Visual Analog Scale (VAS) Pain score [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San DiegoSan DiegoCalifornia92093
Dominic Baun, MS
[email protected]
858-534-8268
William Kent, MD (PRINCIPAL_INVESTIGATOR)

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