Fibulink Syndesmosis Repair System With Early Full-Weight Bearing
Recruiting
N/A
Interventional Study
Ankle Fractures
Bimalleolar Fractures
Syndesmotic Injuries
Bimalleolar Equivalent Fracture
Maisonneuve Fracture
Trimalleolar Fractures
Ankle Dislocation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 22 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 56 (estimated)
- Sponsor
- Maimonides Medical Center · Other
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion 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
* Trimalleol…
Contacts