Status:
COMPLETED
Clinical Application of Mg Based Biodegradable Material for Fracture Fixation in the Adult Skeleton
Lead Sponsor:
Medical University of Graz
Collaborating Sponsors:
Laura Bassi Fond; AUVA
Conditions:
Fracture of Medial Malleolus
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
This study is a prospective, non-randomized trial for the treatment of fractures of the medial malleolus using lean, bioabsorbable, rare-earth element (REE) free, magnesium (Mg)-based biodegradable sc...
Detailed Description
The pilot study was designed as a prospective, nonrandomized trial for the treatment of displaced fractures of the medial malleolus with a lean, REE-free, Mg-based biodegradable implant in the adult s...
Eligibility Criteria
Inclusion
- Patients with a dislocated fracture of the medial malleolus. Dislocation is defined as diastasis of the fracture in any direction of 2 mm or more.
- Otherwise healthy patients (women and men) in the age-group 18 to 65 years
- Subject has been informed of the nature of the study, agrees to participate and signs the approved consent forms. Included in this procedure is the standard information about the operation procedure.
- Subject is able and willing to comply with all assessments in the study
- Female subject with child-bearing potential perform a pregnancy test
Exclusion
- pathological fractures (f.e. bone cyst)
- underlying diseases (particularly bone diseases, kidney diseases, diabetes mellitus)
- poly-traumatized patient
- multiple fractures at the same extremity
- pregnant or breastfeeding women
- inability or unwillingness to give informed consent
Key Trial Info
Start Date :
July 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05245981
Start Date
July 9 2018
End Date
January 17 2023
Last Update
January 31 2023
Active Locations (1)
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1
Medical University of Graz
Graz, Styria, Austria, 8036