Repairing ankle syndesmosis with early full weight bearing
Evaluation of Safety and Performance Outcomes of the Fibulink Syndesmosis Repair System With Early Full-Weight Bearing
This study is testing a new ankle surgery method to see if it helps people with certain ankle fractures recover faster by allowing them to put weight on their foot sooner.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Maimonides Medical Center Academic / other |
| Locations | 1 site (Brooklyn, New York) |
| Trial ID | NCT06085586 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals with ankle fractures that exhibit syndesmotic disruption, such as bimalleolar or Maisonneuve fractures.
Not a fit: Patients with previous ankle surgeries, active infections, or chronic conditions affecting the ankle may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to faster recovery times and improved outcomes for patients with ankle fractures involving syndesmotic injuries.
How similar studies have performed: Other studies have shown promising results with similar fixation techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brooklyn, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.