Syndesmotic Screw Vs Suture Button in Ankle Syndesmotic Diastasis
Launched by TANTA UNIVERSITY · Feb 26, 2025
Trial Information
Current as of June 27, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two different methods for treating a specific type of ankle injury called a syndesmotic injury, which occurs when the ligaments that connect the two bones in the lower leg (the tibia and fibula) are damaged. The researchers want to compare the effectiveness of two treatments: a syndesmotic screw and a suture button. Both methods are used to help stabilize the injury and promote healing, but they work in different ways.
To participate in this study, individuals must be between 18 and 60 years old and have a specific type of ankle injury that is deemed unstable and requires surgery. Some examples of eligible injuries include isolated syndesmotic injuries or fractures of the outer ankle bone. However, people who have had previous ankle surgery on the same side, are not able to walk, or have certain medical conditions may not be eligible. If you join the study, you will receive one of the two treatments and will be monitored after surgery to see how well each method works in helping you heal.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- - Unstable unilateral syndesmotic injuries that was considered by the attending staff surgeon to require surgical fixation, including:
- • Age : 18 - 60 years old.
- • Closed or grade I open fractures are included.
- • Isolated syndesmotic injury.
- • associated lateral malleolus fracture with talar shift.
- • Associated with Bimalleolar fractures.
- • Associated with Trimalleolar fractures that did not require posterior fragment fixation (typically \<25% of articular surface).
- Exclusion Criteria:
- • - Exclusion criteria include patient and injury specific factors.
- Patient-related exclusion factors included:
- • Skeletal immaturity.
- • Previous ipsilateral ankle surgery.
- • Non-ambulatory status before injury.
- • Inability to comply with postoperative protocol (i.e., advanced dementia).
- • Medical unfit patients for surgery.
- • Uncontrolled diabetes mellitus with charcot joint or peripheral neuropathy.
- • Polytrauma patients.
- Injury-related exclusion factors included:
- • Grade II or III open fractures
- • Tibial plafond fractures
- • Posterior malleolar fractures requiring fixation (typically \>25% articular surface involved).
About Tanta University
Tanta University is a prestigious academic institution located in Egypt, dedicated to advancing medical research and education. As a clinical trial sponsor, Tanta University leverages its extensive resources and expertise to conduct innovative research initiatives aimed at improving health outcomes. The university collaborates with a network of healthcare professionals, researchers, and institutions to facilitate rigorous clinical trials across various medical disciplines. Committed to ethical standards and scientific integrity, Tanta University strives to contribute to the global body of knowledge while fostering the next generation of medical professionals.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tanta, El Gharbia, Egypt
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported