Bioresorbable Magnesium Screws for Ankle Syndesmotic Injuries: A First Look
Official title: Einsatz Von Bioresorbierbaren Magnesium-Stellschrauben Bei Syndesmosenverletzungen: Eine Pilotstudie
Run by Medical University of Graz · NCT07901205 · Data updated 2026-11-12
This pilot study tests whether a bioresorbable magnesium screw can safely fix ankle syndesmotic injuries in adults with isolated injuries or small fracture patterns.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Medical University of Graz Academic / other |
| Locations | 1 site (Graz, Styria) |
| Status | Recruiting |
| Started | April 19, 2026 |
| Main results expected | May 2029 |
| Study ends | May 2029 |
| Registry record updated | October 28, 2026 |
| Trial ID | NCT07901205 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years and older with isolated syndesmotic injury or bi-/trimalleolar fractures involving the syndesmosis, who consent to participate.
✕Probably not a fit
Patients with inadequate trauma, osteoporosis, polytrauma, prior ankle surgery, advanced osteoarthritis, systemic inflammatory or degenerative conditions, or those unable to consent may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, single-center pilot study evaluates the function and integration of a bioresorbable magnesium set screw (ZX00) used to fix the syndesmosis in isolated syndesmotic injuries and in bi- or trimalleolar fractures. Participants undergo standard surgery and complete patient-reported outcome measures (NRS, AOFAS, FAAM) at baseline, 2, 4, 6, 12 weeks, and 12 months. Imaging with CT scans at 12 weeks and 12 months assesses implant resorption and integration, while follow-up visits monitor safety and healing. The study focuses on implant performance over 12 weeks and 1 year postoperatively in an elective orthopedic setting.
Why it matters
Potential benefit: If successful, patients could benefit from a resorbable fixation that may eliminate need for hardware removal and support bone healing.
How similar studies have gone: Prior work with bioresorbable implants in orthopedic injuries has shown mixed but promising results; this pilot aims to provide focused data on magnesium-based fixation for the syndesmosis.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Minimum age 18 years * Isolated syndesmotic injury or bi-/trimalleolar fracture with syndesmotic injury * Consent to participate in the study Exclusion Criteria: * Inadequate trauma, diagnosed osteoporosis, or osteopenic bone structure * Polytrauma * Previous surgical treatment of the syndesmosis * Advanced post-traumatic osteoarthritis or pre-existing degenerative or inflammatory diseases of the ankle joint * Underlying conditions (morbid obesity, diabetes mellitus, peripheral vascular disease, fungal foot infection, peripheral neuropathy, rheumatic diseases, autoimmune diseases) * Systemic corticosteroid therapy for more than 3 months * Pregnancy and breastfeeding * Inability or unwillingness to provide informed consent
Where it's running
-
Department of Orthopaedics and Trauma, Medical University of Graz
Graz, Styria, Austria Recruiting
Study contacts
- Principal investigator: Patrick Holweg, PD DDr. — Department of Orthopaedics and Trauma, Medical University of Graz
- Study coordinator: Patrick Holweg, OA PD DDr.
- Email: p.holweg@medunigraz.at
- Phone: +43 316 385 82155
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.