MagnezixKids Study

Thomas Krebs

Status: Completed

Conditions: Bioresrobable Implants; Childhood; Elbow Fracture; Osteosynthesis; Pediatric Elbow Fractures; Magnezix; Magnesium-based

Treatments: Device: Osteosynthesis with resorbable Material

Study type: Interventional

Funder types: Other

Identifiers

NCT04571905

CTU 18.028

Details and patient eligibility

About

The overall objective of the study is to describe the outcomes of osteosyn-thesis with magnesium based screws in children with a primary or second-ary (within 7 days from trauma) dislocated fracture of the Epicondyles ul-naris or Condylus radialis, and to compare them with outcomes of conven-tional osteosynthesis using steel screws.

If our results suggest non-inferiority of osteosynthesis with magnesium-based screws, the procedure could be tested formally in a subsequent full-size study.

Enrollment: 17 patients

Sex: All

Ages: 3 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• primary or secondary (within 7 days from trauma) dislocated fracture of the Epicondyles ulnaris or Condylus radialis (indication for operative treatment according to international standard: Dislocation of more than 2 mm in Condylus radials fractures and more than 5 mm in Epicondylus ulnas fractures )
• Age 3-15 years
• Informed Consent as documented by signature

Exclusion criteria

• • open fractures or complex multi fragment fractures that require dif-ferent osteosynthetic procedures than screw fixation
• severe local accompanying injury (injury to nerves/vessels)
• polytrauma patients
• fracture age > 7 days
• preexisting ipsilateral elbow fracture
• relevant comorbidities, which have influence on fracture and wound healing
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant or the legal representatives
• Previous enrolment into the current study
• Enrolment of the investigator's family members and other dependent persons
• Any of the following applicable absolute and relative contraindica-tions listed in the MAGNEZIX® CBS and CSc 4.8 mm instruction for use :

Absolute contraindications:

• insufficient or avascular bone mass for anchorage of the implant, ex-cept osteochondral fractures and dissecates
• confirmation or suspected septic infectious surgical site
• application in the area of the epiphyseal plates

Relative contraindications:

• acute sepsis
• alcohol, nicotine and/or drug abuse
• epilepsy
• poor skin/soft tissue conditions
• uncooperative patient or patient with restricted intellectual capacity
• no options for adequate postoperative treatment (e.g. temporary strain relief)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Syntellix Treatment Arm

Other group

Description:

General anaesthesia, open fracture reduction, insertion of the appropriate screw with x-ray control and documentation intraoperatively, cast immobilisation Use of bioresorbable Magnezix CS or CBS Screws, if intraoperatively suitable bioresorbable screws not available, use of conventional ostesynthesis screws

Treatment:

Device: Osteosynthesis with resorbable Material