Repairing ankle syndesmosis with early full weight bearing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the Fibulink Syndesmosis Repair System's effectiveness in maintaining the proper alignment of the ankle syndesmosis after fractures. Patients with specific types of ankle fractures will undergo surgery, where the orthopedic team will assess the need for syndesmosis fixation based on intraoperative evaluations. The study aims to allow patients to begin full weight bearing with a Controlled Ankle Motion boot four weeks post-surgery, potentially reducing recovery time compared to traditional methods. The research will involve obtaining informed consent for both the surgical procedure and participation in the study.

Why it matters

Who can join: the full rules

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

Where it's running

• Maimonides Medical Center
  Brooklyn, New York, United States Recruiting

Study contacts

• Principal investigator: Amr A Abdelgawad, MD PhD MBA — Vice Chair of Orthopedic Clinical Programs, Director of Pediatric Orthopedic Surgery
• Study coordinator: Amr A Abdelgawad, MD PhD MBA
• Email: aabdelgawad@maimonidesmed.org
• Phone: 7182837400

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.