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Suture Button vs Screw Fixation for Ankle Syndesmosis Injury
N/A
Recruiting
Led By Sarah M Putnam, MD
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Syndesmotic instability (determined either pre- or intra-operatively)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is looking at whether or not there is a difference between two common treatments for syndesmotic injuries (screw fixation and suture fixation).
Who is the study for?
This trial is for adults over 19 with a specific ankle injury called syndesmosis instability, often part of rotational ankle fractures. Candidates should have stable fibula fractures and no prior trauma or surgery to the injured ankle. Those with unstable fracture patterns, previous stability in the syndesmosis, non-ambulatory status, lower extremity neuropathy, or who used walking aids before their injury cannot participate.Check my eligibility
What is being tested?
The study compares two treatments for an ankle injury known as syndesmosis: suture button fixation versus screw fixation. It aims to see which method leads to better gait outcomes post-surgery since current evidence doesn't clearly show one being superior over the other in terms of patient-reported results.See study design
What are the potential side effects?
While not explicitly stated here, common side effects from such surgical interventions may include pain at the site of surgery, swelling around the ankle joint, difficulty with range of motion initially after surgery and potential complications related to hardware placement like infection or irritation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My ankle joint is unstable.
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
Gait parameter - Double support time
Gait
Gait parameter - Stance time
+4 moreSecondary outcome measures
Ankle range of motion
Development of radiographic arthritis
Implant complications
+6 moreTrial Design
2Treatment groups
Active Control
Group I: Screw FixationActive Control1 Intervention
Traditional fixation method of placing one or two screws across the syndesmosis.
Group II: Suture ButtonActive Control1 Intervention
Suture button implants which use a suture and anchor to repair the syndesmosis
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Who is running the clinical trial?
University of NebraskaLead Sponsor
539 Previous Clinical Trials
1,144,656 Total Patients Enrolled
Sarah M Putnam, MDPrincipal InvestigatorUniversity of Nebraska
Sarah Putnam, M.D.Principal InvestigatorUniversity of Nebraska
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I used a walking aid before my injury.My fracture is unstable and may include a specific type called Maisonneuve.I am 19 years old or older.My ankle joint is unstable.I cannot walk by myself.I have nerve pain or weakness in my legs.I have had an injury or surgery on my ankle before.I have a broken bone that is exposed through my skin.My ankle joint is stable.
Research Study Groups:
This trial has the following groups:- Group 1: Screw Fixation
- Group 2: Suture Button
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.
What aims is this trial aiming to accomplish?
"This scientific investigation, which is expected to take around one year to complete, has the primary goal of assessing gait parameter swing times. Secondary endpoints are patient-reported outcomes (PROMIS LE) scores, time until fracture union healing and implant-related complications such as screw fractures or loss of fixation. PROMIS LE T Scores range from 0 - 100 with 50 being equal to the population mean; higher numbers suggest improved physical function."
Answered by AI
Are there any vacancies available for potential participants in this research project?
"According to clinicaltrials.gov, this medical experiment is still recruiting subjects. The trial was first announced on October 1st 2021 and the details were last modified March 1st 2022."
Answered by AI
How many participants can be accepted for this trial?
"Affirmative. According to clinicaltrials.gov, this medical study is accepting new patients as of March 1st 2022; it was first advertised on October 1st 2021 and requires 78 participants at a single facility."
Answered by AI
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