Ankle InjuriesNCT05729542
Comparing Clinical Outcomes of Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
A study testing Arthrex Tightrope and Synthes Fibulink in people with Ankle Injuries and Syndesmotic Injuries, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ankle Injuries, Syndesmotic Injuries, Ankle Fractures
- What is being tested?
- Arthrex Tightrope and Synthes Fibulink
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2021to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Diego
San Diego, California, 92093
Dominic Baun, MS, 858-534-8268, jbaun@health.ucsd.edu
William Kent, MD
About this study
Official title: Randomized Controlled Trial Comparing Clinical Outcomes of Patients Treated Surgically With Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
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.
- Conditions
- Ankle Injuries, Syndesmotic Injuries, Ankle Fractures
- Being tested
- Arthrex Tightrope, Synthes Fibulink
- Medical subject headings
- Ankle Injuries, Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthrex TightropeDevice
High-tensile strength suture syndesmosis repair
Synthes FibulinkDevice
High-tensile strength suture syndesmosis repair
| Study group | Role | What they receive |
|---|---|---|
| Arthrex Tightrope | Active comparator | Syndesmosis fixation performed with ARthrex Tightrope device. This is a high-tension suture fixation with a button based anchor system. Receives: Device: Arthrex Tightrope |
| Synthes Fibulink | Experimental | Syndesmosis fixation perforemd with Synthes Fibulink device. This is a high-tension fixation with a screw based anchor system. Receives: Device: Synthes Fibulink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) Pain score
VAS Pain score is rated from 0-10, 0=no pain and 10=most severe pain
Measured: 1 year
Foot and Ankle Disability Index
Functional score with a 0-104 with higher scores indicating better function
Measured: 1 year
Olerud-Molander Ankle Score
Functional Score with a score of 0-100 with higher scores indicating better function
Measured: 1 year
Secondary outcomes (1)
Number of participants with medical or surgical complications
Medical and surgical complications to include: surgical site infection, re-operation, device failure, loss of motion
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start18 Nov 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle InjuriesStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Kent, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729542
- Sponsor's protocol ID
- 800669
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2023
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Clinical Outcomes of Patients Treated Surgically With Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
- ClinicalTrials.gov ID
- NCT05729542
- Acronym / sponsor ID
- 800669
- Conditions
- Ankle Injuries, Syndesmotic Injuries, Ankle Fractures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthrex Tightrope | Active comparator | Device: Arthrex TightropeSyndesmosis fixation performed with ARthrex Tightrope device. This is a high-tension suture fixation with a button based anchor system. |
| Synthes Fibulink | Experimental | Device: Synthes FibulinkSyndesmosis fixation perforemd with Synthes Fibulink device. This is a high-tension fixation with a screw based anchor system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Any not medically managed severe systemic disease
- Patient preference for specific implant
- Refusal of randomization
- Pregnant patients
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthrex TightropeHigh-tensile strength suture syndesmosis repair | Device | Arthrex Tightrope |
| Synthes FibulinkHigh-tensile strength suture syndesmosis repair | Device | Synthes Fibulink |
Primary outcome
Visual Analog Scale (VAS) Pain score
Time frame: 1 year
VAS Pain score is rated from 0-10, 0=no pain and 10=most severe pain
Foot and Ankle Disability Index
Time frame: 1 year
Functional score with a 0-104 with higher scores indicating better function
Olerud-Molander Ankle Score
Time frame: 1 year
Functional Score with a score of 0-100 with higher scores indicating better function
1 secondary outcome
Number of participants with medical or surgical complications
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthrex Tightrope and Synthes Fibulink in people with Ankle Injuries and Syndesmotic Injuries, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dominic Baun, MS (858-534-8268, jbaun@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) Pain score (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.