Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT04571905
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
15 Years
Study:
NCT04571905
Study Brief:
Protocol Section:
NCT04571905