Fibulink Syndesmosis Repair System With Early Full-Weight Bearing

Launched by MAIMONIDES MEDICAL CENTER · Oct 10, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Fibulink Syndesmosis Repair System, which is designed to help fix certain types of ankle fractures and injuries. Specifically, the trial aims to see how well this system can keep the bones in the ankle stable after surgery, which is really important to prevent future problems like arthritis. A key part of this study is to test if patients can start putting their full weight on the injured ankle earlier—just four weeks after surgery—while wearing a special boot. This is a significant improvement because current methods often require patients to wait longer, which can slow down recovery.

To be eligible for this study, participants must have specific types of ankle fractures that involve disruption of the syndesmosis, which is the fibrous joint connecting the two bones in the lower leg. Examples include bimalleolar ankle fractures and Maisonneuve fractures. However, people with previous ankle surgeries, infections, certain chronic conditions, or who are pregnant cannot participate. If someone joins the study, they can expect close monitoring and support as they recover, contributing to important research that could improve ankle injury treatments in the future.

Gender

ALL

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
• • Trimalleolar ankle fractures without the need for posterior malleolus fixation
• • Ankle fracture dislocations
• Exclusion Criteria:
• • 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) peripheral neuropathy, 8) diabetes neuropathy and charcot, 9) open fractures, 10) poly trauma, 11) inability to provide informed consent, 12) symptomatic ankle osteoarthritis, 12) retained hardware, 13) pregnant, 14) metabolic bone disease, 15) history of chronic steroid use, 16) mal-reduced ankle fractures