Overview
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
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
