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Randomized Controlled Trial Comparing Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
NCT05626036 · View on ClinicalTrials.gov ↗
Study Summary
Ankle fractures are a common injury with potentially significant morbidity. Syndesmosis injury occurs in 10% to 13% of ankle fractures and poses a greater risk to long-term outcomes for patients. The gold standard for syndesmosis fixation has traditionally been screw fixation. However, issues with screw fixation include screw breakage, screw loosening, reoperation, and malreduction. Due to growing concerns with static screw fixation, implants based on the flexible suture button design, such as the TightRope system, gained traction. The Fibulink Syndesmosis Repair System, a relatively new design that became clinically available in 2017, has showed promising results. To our knowledge, there is no study that directly compares outcomes with the Fibulink implant to suture button implants.
Conditions Studied
Interventions
- DEVICE Arthrex Tightrope
- DEVICE Synthes Fibulink
Study Locations (1)
California
- Naval Medical Center San Diego — San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-12-01 |
| Est. Completion | 2024-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05626036
The ClinicalTrials.gov registry entry for NCT05626036 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is United States Naval Medical Center, San Diego, which has 64 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Syndesmotic Injuries appearing as the primary indexed condition, and to 2 interventions — of which Arthrex Tightrope is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05626036 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05626036 about?
NCT05626036 is a clinical study titled "Randomized Controlled Trial Comparing Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries". Ankle fractures are a common injury with potentially significant morbidity. Syndesmosis injury occurs in 10% to 13% of ankle fractures and poses a greater risk to long-term outcomes for patients. The gold standard for syndesmosis fixation has traditionally been screw fixation. However, issues with ...
What is the current status of trial NCT05626036?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2022-12-01. Estimated completion is 2024-12.
What conditions does trial NCT05626036 study?
This clinical trial studies the following conditions: Syndesmotic Injuries. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05626036?
The interventions under investigation include: Arthrex Tightrope (DEVICE), Synthes Fibulink (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05626036?
This trial is sponsored by United States Naval Medical Center, San Diego, which has 64 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05626036 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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