Recruiting

Suture Button vs. Fibulink

Sponsor:

United States Naval Medical Center, San Diego

Code:

NCT05626036

Conditions

Syndesmotic Injuries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Arthrex Tightrope

Synthes Fibulink

Study Details

Brief summary:

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 ID

NCT05626036

Start date

Dec 1, 2022

Status verified date

May, 2024

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Arthrex Tightrope

High-tensile strength suture syndesmosis repair

Synthes Fibulink

High-tensile strength suture syndesmosis repair

Primary outcome measure

  • Visual Analog Scale (VAS) pain score [ Time Frame: 1 year ]
  • Foot and Ankle Disability Index [ Time Frame: 1 year ]
  • Olerud-Molander Ankle Score [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Ashley Hughey

619-532-9535ashley.e.hughey.ctr@health.mil

Locations

Naval Medical Center San Diego

Recruiting

San Diego, California, United States, 92134

Principal Investigator:

Benjamin Wheatley

More Information

Sponsor

United States Naval Medical Center, San Diego

Last update posted

May 6, 2024

Last verified

May, 2024

Keywords

  • syndesmosis
  • clinical outcomes
  • ankle fracture

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-20. This information was provided to ClinicalTrials.gov by United States Naval Medical Center, San Diego on 2024-05-06.