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

NCT05245981 | Completed Phase 2 DMC

• 1 other identifier: BRI.MAG 2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (3)

• Safety: Absence of (Serious) Adverse Events (SAE) throughout the study

  (Serious) Adverse Events defined as: * Secondary (post-op) diastasis of the distal tibiofibular joint assessed by two plane x-rays * Secondary diastasis of the malleolus medialis assessed by two plane x-rays. * Infection of the osteosynthesis assessed clinically and/or radiologically with the presence of at least three of the following signs: clinically: pain, swelling, warmth and redness in the infected area, chills and fever x-rays: regional osteopenia, periosteal reaction/thickening, Codman's triangle, focal bony lysis, loss of bony trabecular architecture, new bone apposition

  3 years after surgery

• Primary Efficacy- Change of stability of the distal tibiofibular joint

  Stability of the distal tibiofibular joint reduced with two BRI.MAG screws assessed by two plane x-rays after surgery, at 2 weeks and at 6 weeks s and at 6 weeks

  after surgery, at 2 weeks and at 6 weeks

• Primary Efficacy- Change of stability of the fracture of the medial malleolus

  Stability of the fracture of the medial malleolus reduced by two BRI.MAG screws assessed by two plane x-rays after surgery, at 2 weeks and at 6 weeks

  after surgery, at 2 weeks and at 6 weeks

Secondary Outcomes (2)

• Procedural success - operation procedure

  6 weeks

• Procedural success- complications

  6 weeks

Study Arms (1)

BRI.MAG 2

EXPERIMENTAL

Patients presenting with dislocated isolated or combined fracture of the medialis malleolus are eligible to receive the investigational device.

Device: BRI.MAG 2

Interventions

BRI.MAG 2 DEVICE

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.

BRI.MAG 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead
• Laura Bassi Fond; AUVA: collaborator

Study Sites (1)

Medical University of Graz

Graz, Styria, 8036, Austria

Location

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Study Officials

• Franz Josef Seibert, Prof.Dr.

  Medical University of Graz, Departement of orthopaedics and traumatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 18, 2022
• Study Start: July 9, 2018
• Primary Completion: January 17, 2023
• Study Completion: January 17, 2023
• Last Updated: January 31, 2023

Record last verified: 2023-01

Locations

AU (1)