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Fibulink Syndesmosis Repair System With Early Full-Weight Bearing
NCT06085586 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of the study is to evaluate the ability of the Fibulink Syndesmosis Repair System to maintain reduction of the ankle syndesmosis. Appropriate reduction of the syndesmosis is critical due the changes in tibiotalar contact pressure observed in cadaveric studies.6,7 Malreduction and instability of the distal tibiotalar joint can lead to chronic instability, increased articular damage and ultimately degenerative arthritis.7,8 Medial to lateral translation of distal tibia and fibula of 2 mm or more has been considered pathologic.9 Earlier biomechanical study demonstrated the Fibulink system is superior in maintaining displacement of less than 2 mm.4 Given the improved strength, we also look to evaluate the outcomes of initiating full weight bearing (100%) with Controlled Ankle Motion (CAM) boot at 4 weeks postoperatively. One of the big limitations for trans-osseous screw fixation is delayed weight bearing due to risk of screw breakage.1 Suture button technique allowed for early weight bearing with average of 6 weeks postoperatively using TightRope.2,10-12By initiating full weight bearing (100%) with CAM boot at 4 weeks postoperatively, this would be a significant improvement in current clinical practice.
Conditions Studied
Interventions
- OTHER Early Weight Bearing
- OTHER Normal Weight Bearing
Study Locations (1)
New York
- Maimonides Medical Center — Brooklyn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2023-07-13 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06085586
The ClinicalTrials.gov registry entry for NCT06085586 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 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Maimonides Medical Center, which has 11 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 7 conditions, with Ankle Fractures appearing as the primary indexed condition, and to 2 interventions — of which Early Weight Bearing 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: NCT06085586 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. 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 NCT06085586 about?
NCT06085586 is a clinical study titled "Fibulink Syndesmosis Repair System With Early Full-Weight Bearing". The purpose of the study is to evaluate the ability of the Fibulink Syndesmosis Repair System to maintain reduction of the ankle syndesmosis. Appropriate reduction of the syndesmosis is critical due the changes in tibiotalar contact pressure observed in cadaveric studies.6,7 Malreduction and instabi...
What is the current status of trial NCT06085586?
This trial is currently recruiting. It is a NA study. The enrollment target is 56 participants. The study started on 2023-07-13. Estimated completion is 2026-12-31.
What conditions does trial NCT06085586 study?
This clinical trial studies the following conditions: Ankle Fractures, Syndesmotic Injuries, Bimalleolar Fractures, Bimalleolar Equivalent Fracture, Maisonneuve Fracture. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06085586?
The interventions under investigation include: Early Weight Bearing (OTHER), Normal Weight Bearing (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06085586?
This trial is sponsored by Maimonides Medical Center, which has 11 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06085586 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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