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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Arthrex Tightrope 		Syndesmosis fixation performed with ARthrex Tightrope device. This is a high-tension suture fixation with a button based anchor system.
  • Device: Arthrex Tightrope
    High-tensile strength suture syndesmosis repair
Experimental
Synthes Fibulink 		Syndesmosis fixation perforemd with Synthes Fibulink device. This is a high-tension fixation with a screw based anchor system.
  • Device: Synthes Fibulink
    High-tensile strength suture syndesmosis repair

Recruiting Locations

University of California, San Diego
San Diego 5391811, California 5332921 92093
Contact:
Dominic Baun, MS
858-534-8268
jbaun@health.ucsd.edu

More Details

Status
Recruiting
Sponsor
University of California, San Diego

Study Contact

Dominic Baun, MS
858-534-8268
jbaun@health.ucsd.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.