Randomized Controlled Trial Comparing Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries

Description

Ankle fractures are a common injury with potentially significant morbidity. Syndesmosis injury occurs in 10% to 13% of ankle fractures and poses a greater risk to long-term outcomes for patients. The gold standard for syndesmosis fixation has traditionally been screw fixation. However, issues with screw fixation include screw breakage, screw loosening, reoperation, and malreduction. Due to growing concerns with static screw fixation, implants based on the flexible suture button design, such as the TightRope system, gained traction. The Fibulink Syndesmosis Repair System, a relatively new design that became clinically available in 2017, has showed promising results. To our knowledge, there is no study that directly compares outcomes with the Fibulink implant to suture button implants.

Conditions

Syndesmotic Injuries

Study Overview

Study Details

Study overview

Ankle fractures are a common injury with potentially significant morbidity. Syndesmosis injury occurs in 10% to 13% of ankle fractures and poses a greater risk to long-term outcomes for patients. The gold standard for syndesmosis fixation has traditionally been screw fixation. However, issues with screw fixation include screw breakage, screw loosening, reoperation, and malreduction. Due to growing concerns with static screw fixation, implants based on the flexible suture button design, such as the TightRope system, gained traction. The Fibulink Syndesmosis Repair System, a relatively new design that became clinically available in 2017, has showed promising results. To our knowledge, there is no study that directly compares outcomes with the Fibulink implant to suture button implants.

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

Randomized Controlled Trial Comparing Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries

Condition
Syndesmotic Injuries
Intervention / Treatment

-

Contacts and Locations

San Diego

Naval Medical Center San Diego, San Diego, California, United States, 92134

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

United States Naval Medical Center, San Diego,

Benjamin Wheatley, PRINCIPAL_INVESTIGATOR, NMCSD

Study Record Dates

2024-12