Back to resultsComparing Clinical Outcomes of Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
Primary Purpose
Ankle Injuries, Syndesmotic Injuries, Ankle Fractures
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arthrex Tightrope
Synthes Fibulink
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Injuries
Eligibility Criteria
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
Sites / Locations
- University of California, San DiegoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arthrex Tightrope
Synthes Fibulink
Arm Description
Syndesmosis fixation performed with ARthrex Tightrope device. This is a high-tension suture fixation with a button based anchor system.
Syndesmosis fixation perforemd with Synthes Fibulink device. This is a high-tension fixation with a screw based anchor system.
Outcomes
Primary Outcome Measures
Visual Analog Scale (VAS) Pain score
VAS Pain score is rated from 0-10, 0=no pain and 10=most severe pain
Foot and Ankle Disability Index
Functional score with a 0-104 with higher scores indicating better function
Olerud-Molander Ankle Score
Functional Score with a score of 0-100 with higher scores indicating better function
Secondary Outcome Measures
Number of participants with medical or surgical complications
Medical and surgical complications to include: surgical site infection, re-operation, device failure, loss of motion
Full Information
NCT ID
NCT05729542
First Posted
February 6, 2023
Last Updated
March 6, 2023
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT05729542
Brief Title
Comparing Clinical Outcomes of Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
Official Title
Randomized Controlled Trial Comparing Clinical Outcomes of Patients Treated Surgically With Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 18, 2021 (Actual)
Primary Completion Date
November 18, 2024 (Anticipated)
Study Completion Date
November 18, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This project consists of a randomized controlled study design. Study candidates will include all patients 18 years or older, who were evaluated at UCSD and found to have an acute ankle syndesmosis injury requiring surgery. Patients who consent to study participation will be randomized to receive one of two standard of care procedures - either a suture button or Fibulink implant. Outcome measures, including the Olerud-Molander and American Orthopaedic Foot and Ankle Society scores, pain, range of motion, time to return to work, and radiographic evaluation will be collected for each participant. Given the potential degenerative changes and poor radiographic and clinical outcomes with inadequate repair of the syndesmosis, it is imperative to evaluate existing and emerging methods of fixation for patients with acute ankle fractures with syndesmosis injuries.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Injuries, Syndesmotic Injuries, Ankle Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arthrex Tightrope
Arm Type
Active Comparator
Arm Description
Syndesmosis fixation performed with ARthrex Tightrope device. This is a high-tension suture fixation with a button based anchor system.
Arm Title
Synthes Fibulink
Arm Type
Experimental
Arm Description
Syndesmosis fixation perforemd with Synthes Fibulink device. This is a high-tension fixation with a screw based anchor system.
Intervention Type
Device
Intervention Name(s)
Arthrex Tightrope
Intervention Description
High-tensile strength suture syndesmosis repair
Intervention Type
Device
Intervention Name(s)
Synthes Fibulink
Intervention Description
High-tensile strength suture syndesmosis repair
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS) Pain score
Description
VAS Pain score is rated from 0-10, 0=no pain and 10=most severe pain
Time Frame
1 year
Title
Foot and Ankle Disability Index
Description
Functional score with a 0-104 with higher scores indicating better function
Time Frame
1 year
Title
Olerud-Molander Ankle Score
Description
Functional Score with a score of 0-100 with higher scores indicating better function
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of participants with medical or surgical complications
Description
Medical and surgical complications to include: surgical site infection, re-operation, device failure, loss of motion
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominic Baun, MS
Phone
858-534-8268
Email
jbaun@health.ucsd.edu
First Name & Middle Initial & Last Name or Official Title & Degree
William Kent, MD
Phone
619-543-2694
Email
wkent@health.ucsd.edu
Facility Information:
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominic Baun, MS
Phone
858-534-8268
Email
jbaun@health.ucsd.edu
First Name & Middle Initial & Last Name & Degree
William Kent, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparing Clinical Outcomes of Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
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