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NCT06085586 · ClinicalTrials.gov registry record · NA
Fibulink Syndesmosis Repair System With Early Full-Weight Bearing
A NA study of Ankle Fractures and Syndesmotic Injuries, sponsored by Maimonides Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 56
- Enrollment target
- 1
- Study location
NCT06085586: Recruiting NA study of Ankle Fractures and Syndesmotic Injuries, sponsored by Maimonides Medical Center.
NCT06085586 is a NA study of Ankle Fractures and Syndesmotic Injuries that is actively recruiting participants, run by Maimonides Medical Center. The registered enrollment target is 56 participants, below the 249-participant average among 12 other Ankle Fractures trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06085586, a NA study of Ankle Fractures and Syndesmotic Injuries, is actively recruiting participants, sponsored by Maimonides Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 56 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The primary objective is to evaluate the reduction and maintenance of the reduction of ankle syndesmosis in 6 months after initiating full weight bearing (100%) at 4 weeks or 6 weeks postoperatively. This will be determined based on comparing the tibiofibular overlap, tibiofibular clear space and medial clear space preoperative values.
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 |
What NCT06085586 shows while recruiting
NCT06085586 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 249-participant average among 12 other Ankle Fractures trials with a reported enrollment target (78% lower).
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.
NCT06085586 reports a single indexed study location in New York.
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.
What interventions are being tested in trial NCT06085586?
The interventions under investigation include: Early Weight Bearing (OTHER), Normal Weight Bearing (OTHER).
Who is sponsoring clinical trial NCT06085586?
This trial is sponsored by Maimonides Medical Center, which has 39 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06085586's enrollment target sits among peer trials
56 8th of 12 higher than 5 of 12 other Ankle Fractures trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ankle Fractures trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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