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New treatment option for Ankle Fractures
Official title Fibulink Syndesmosis Repair System With Early Full-Weight Bearing
ClinicalTrials.gov ID: NCT06085586
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older. Healthy volunteers may be eligible.
You may be able to join if
- ankle fracture with syndesmotic disruption as assessed with intra-operative cotton test. This includes the following injuries:
- Syndesmotic sprain (without fractures)
- Bimalleolar equivalent ankle fractures
- Bimalleolar ankle fractures
- Maisonneuve fractures
You likely can't join if
- 1) previous ankle surgery, 2) active local infection about the ankle, 3) chronic ankle deformity secondary to trauma or congenital, 4) ligamentous...
See the full eligibility criteria
- ankle fracture with syndesmotic disruption as assessed with intra-operative cotton test. This includes the following injuries:
- Syndesmotic sprain (without fractures)
- Bimalleolar equivalent ankle fractures
- Bimalleolar ankle fractures
- Maisonneuve fractures
- Trimalleolar ankle fractures without the need for posterior malleolus fixation
- Ankle fracture dislocations
- 1) previous ankle surgery, 2) active local infection about the ankle, 3) chronic ankle deformity secondary to trauma or congenital, 4) ligamentous laxity, 5) pathologic fractures, 6) peripheral vascular disease, 7)...
The study team makes the final eligibility decision.
Where it's taking place
- Brooklyn, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brooklyn, New York, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.