Clinical trial NCT04571905: MagnezixKids Study
Official title: "Magnesium-based, Bioresorbable Implants for Pediatric Elbow Fractures, a Single Center Pilot Study for Osteosynthesis With Magnezix Screws in Fractures of the Epicondylus Ulnaris and Condylus Radialis."
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Magnesium-based
Bioresrobable Implants
Pediatric Elbow Fractures
Osteosynthesis
Childhood
Magnezix
Elbow Fracture
Lead sponsor: Ostschweizer Kinderspital
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 17
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Clinical and radiologic outcome (fracture consolidation)
timeFrame: 12 months
Secondary outcomes:
measure: Analgesic reuirement
timeFrame: 12 months
measure: ROM
timeFrame: 12 months
measure: Woundhealing
timeFrame: 12 months
measure: Clinical fracture consolidation after one year
timeFrame: 12 months
Other outcomes:
Locations:
city: Saint Gallen
country: Switzerland
facility: Childres Hospital of Eastern Switzerland
Study officials:
References: