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

NCT05626036 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-05-06

No results posted yet for this study

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

Interventions

DEVICE

Arthrex Tightrope

High-tensile strength suture syndesmosis repair

DEVICE

Synthes Fibulink

High-tensile strength suture syndesmosis repair

Sponsors & Collaborators

  • United States Naval Medical Center, San Diego

    lead FED

Principal Investigators

  • Benjamin Wheatley · NMCSD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05626036 on ClinicalTrials.gov