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Clinical Application of Mg Based Biodegradable Material for Fracture Fixation in the Adult Skeleton

NCT05245981 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-01-31

No results posted yet for this study

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 screws in the adult skeleton.

A total of 20 patients with isolated, bimalleolar, or trimalleolar ankle fractures were recruited between July 2018 and October 2019. Fracture reduction was achieved through bioabsorbable Mg-based screws composed of pure Mg alloyed with zinc (Zn) and calcium (Ca) (0.45 wt% Zn and 0.45 wt% Ca; ZX00). Visual analogue scale (VAS) and the presence of complications (adverse events) during follow-up (12 weeks) were used to evaluate the clinical outcomes. The functional outcomes were analyzed through the range of motion (ROM) of the ankle joint and the American Orthopaedic Foot and Ankle Society (AOFAS) score. Fracture reduction and gas formation were assessed using several plane radiographs.

Conditions

  • Fracture of Medial Malleolus

Interventions

DEVICE

BRI.MAG 2

Patients presenting with dislocated isolated or combined fracture of the medialis malleolus, will be screened for eligibility. Every effort will be made to ensure eligibility of the patients prior to enrollment. 20 patients will be recruited for the study.

Sponsors & Collaborators

  • Laura Bassi Fond; AUVA

    collaborator UNKNOWN

  • Medical University of Graz

    lead OTHER

Principal Investigators

  • Franz Josef Seibert, Prof.Dr. · Medical University of Graz, Departement of orthopaedics and traumatology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-09
Primary Completion
2023-01-17
Completion
2023-01-17

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05245981 on ClinicalTrials.gov