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Use of Bioresorbable Magnesium Set Screws in Syndesmotic Injuries: a Pilot Study
Sponsor: Patrick Lukas Holweg, MD
Summary
The primary aim of this prospective single-center pilot study is to evaluate the implant function of the bioresorbable magnesium set screw (ZX00) for the surgical fixation of the syndesmosis in isolated syndesmotic injuries as well as in bi- and trimalleolar fractures after 12 weeks and 1 year postoperatively. Participants will be routinely operated due to a isolated syndesmotic injury at the department of orthopaedics and trauma. For study purposes patients were asked to complete three questionnaires (NRS, AOFAS, FAAM) at baseline visit, 2, 4, 6, 12 weeks and 12 months follow up. To assess implant integration and resorption kinetics, a CT scan will be performed after 12 weeks and after 1 year.
Official title: Einsatz Von Bioresorbierbaren Magnesium-Stellschrauben Bei Syndesmosenverletzungen: Eine Pilotstudie
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
OBSERVATIONAL
Enrollment
20
Start Date
2026-04-19
Completion Date
2029-05
Last Updated
2026-10-28
Healthy Volunteers
No
Locations (1)
Department of Orthopaedics and Trauma, Medical University of Graz
Graz, Styria, Austria