NCT07901205 Use of Bioresorbable Magnesium Set Screws in Syndesmotic Injuries: a Pilot Study
| NCT ID | NCT07901205 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Patrick Lukas Holweg, MD |
| Condition | Syndesmotic Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-04-19 |
| Primary Completion | 2029-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2026-04-19 with a primary completion date of 2029-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Patrick Holweg, PD DDr.
PRINCIPAL INVESTIGATOR
Department of Orthopaedics and Trauma, Medical University of Graz
Frequently Asked Questions
Who can join the NCT07901205 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Syndesmotic Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07901205 currently recruiting?
Yes, NCT07901205 is actively recruiting participants. Contact the research team at p.holweg@medunigraz.at for enrollment information.
Where is the NCT07901205 trial being conducted?
This trial is being conducted at Graz, Austria.
Who is sponsoring the NCT07901205 clinical trial?
NCT07901205 is sponsored by Patrick Lukas Holweg, MD. The principal investigator is Patrick Holweg, PD DDr. at Department of Orthopaedics and Trauma, Medical University of Graz. The trial plans to enroll 20 participants.