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NCT05626036 · ClinicalTrials.gov registry record · NA
Randomized Controlled Trial Comparing Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
A NA study of Syndesmotic Injuries, sponsored by United States Naval Medical Center, San Diego.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05626036 is a NA study of Syndesmotic Injuries that is actively recruiting participants, run by United States Naval Medical Center, San Diego. The registered enrollment target is 50 participants, below the 195-participant average among 3 other Syndesmotic Injuries trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05626036, a NA study of Syndesmotic Injuries, is actively recruiting participants, sponsored by United States Naval Medical Center, San Diego.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 195-participant average among 3 other Syndesmotic Injuries trials with a reported enrollment target (74% lower). The listed sponsor is United States Naval Medical Center, San Diego, which has 41 total studies on file at ClinicalTrials.gov.
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.
NCT05626036 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
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.
What interventions are being tested in trial NCT05626036?
The interventions under investigation include: Arthrex Tightrope (DEVICE), Synthes Fibulink (DEVICE).
Who is sponsoring clinical trial NCT05626036?
This trial is sponsored by United States Naval Medical Center, San Diego, which has 41 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
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