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Procedure
Suture Button vs Fibulink Fixation for Ankle Injury
N/A
Recruiting
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ankle fracture with associated syndesmotic injury requiring surgery
Age 18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will compare two common ankle surgery methods to see which is most effective for treating syndesmosis injuries.
Who is the study for?
This trial is for adults over 18 with an acute ankle syndesmosis injury that needs surgery. Candidates must understand the consent form and can't be in another drug study, imprisoned, pregnant, have severe systemic disease not managed medically, or prefer a specific implant.Check my eligibility
What is being tested?
The study compares two surgical procedures to fix ankle syndesmosis injuries: one uses a suture button (Arthrex Tightrope) and the other uses Fibulink implant. Patients are randomly assigned to either method to see which one leads to better healing and recovery.See study design
What are the potential side effects?
Potential side effects from these surgical interventions may include pain at the surgery site, limited range of motion during recovery, delayed return to work or usual activities due to complications or prolonged healing time.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need surgery for a broken ankle with a specific ligament injury.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
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 perforemd with Synthes Fibulink device. This is a high-tension 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.
Find a Location
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,123 Previous Clinical Trials
1,552,699 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have participated in another study involving medication within the last month that could affect the results of this study.I do not have any severe illnesses that are not under control.I need surgery for a broken ankle with a specific ligament injury.I am 18 years old or older.I do not agree to be randomly assigned to a treatment group.You are pregnant.You can read and understand the information provided in the consent form.I prefer a specific type of implant for my treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Arthrex Tightrope
- Group 2: Synthes Fibulink
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available openings in this research project?
"That is accurate. According to the clinicaltrials.gov webpage, this medical study first went live on November 18th 2021 and has been actively recruiting ever since its last update on February 6th 2023. The research team wishes to include 140 patients from one location for their trial."
Answered by AI
How many participants are currently enlisted in this experiment?
"Affirmative. Clinicaltrials.gov documents that this medical experiment, initiated on November 18th 2021, is currently enlisting volunteers. Approximately 140 individuals are being recruited from one location."
Answered by AI
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