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Implant

Suture Button vs. Fibulink for Ankle Injury

N/A

Waitlist Available

Led By Benjamin Wheatley

Research Sponsored by United States Naval Medical Center, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial seeks to compare outcomes from traditional screw fixation to outcomes from the Fibulink implant. Ankle fractures can cause long-term issues, so this trial compares two methods for fixing the syndesmosis injury, to improve outcomes for patients.

Who is the study for?

This trial is for adults over 18 with an ankle fracture and syndesmosis injury needing surgery, who can understand the consent form. It's not for those with a preference for implant type, against random treatment assignment, prisoners, pregnant women, severe systemic disease unmanaged medically or in another drug study recently.Check my eligibility

What is being tested?

The trial compares two types of fixation devices used in ankle injury surgeries: Arthrex Tightrope (a suture button system) and Synthes Fibulink. The goal is to see which device leads to better long-term outcomes after an ankle fracture with syndesmosis injury.See study design

What are the potential side effects?

Potential side effects may include issues related to the surgical procedure such as infection or pain at the implant site, problems with bone healing around the device, allergic reactions to materials in the implants, and possible need for additional surgeries.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Foot and Ankle Disability Index

Olerud-Molander Ankle Score

Visual Analog Scale (VAS) pain score

Secondary outcome measures

Number of participants with medical or surgical complications

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Synthes FibulinkExperimental Treatment1 Intervention

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

Group II: Arthrex TightropeActive Control1 Intervention

Syndesmosis fixation performed with Arthrex Tightrope device. This is a high-tension suture fixation with a button based anchor system.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

United States Naval Medical Center, San DiegoLead Sponsor

102 Previous Clinical Trials

22,666 Total Patients Enrolled

Benjamin WheatleyPrincipal InvestigatorNMCSD

Media Library

Arthrex Tightrope (Implant) Clinical Trial Eligibility Overview. Trial Name: NCT05626036 — N/A

Syndesmotic Injury Research Study Groups: Arthrex Tightrope, Synthes Fibulink

Syndesmotic Injury Clinical Trial 2023: Arthrex Tightrope Highlights & Side Effects. Trial Name: NCT05626036 — N/A

Arthrex Tightrope (Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05626036 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals being enrolled in this research project at present?

"Information hosted on clinicaltrials.gov manifests that this trial is no longer recruiting patients, having been initially posted in December 1st 2022 and last updated November 22nd 2022. Nevertheless, there are still 765 other studies actively enrolling participants at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Benjamin Wheatley 2022. "Randomized Controlled Trial Comparing Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05626036.