MagnezixKids Study

Study Overview
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Brief Summary
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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.

Official Title
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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.

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

Intervention / Treatment
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* Device: Osteosynthesis with resorbable Material


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Syntellix Treatment Arm<br>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 | Device: Osteosynthesis with resorbable Material<br>* Osteosynthesis with Magnezix screws in fractures of the Epicondylus ulnaris and Condylus radialis under General anaesthesia<br>* Other names: Magnezix (Syntellix) screws;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and radiologic outcome (fracture consolidation) | radiologic outcome after osteosynthesis with magnesium based screws in children with a primary or secondary (within 7 days from trauma) dislocated fracture of the Epicondyles ulnaris or Condylus radialis Fracture alignment is measured as dislocation distance (mm). Appropriate alignement is a postopera-tive dehiscence or dislocation of less than 5 mm in Epicondylus ulnaris fractures and less than 2 mm in Condylus radialis fractures, according to literature (26/27/31). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic reuirement | Analgesic requirement via Pain score (Visual Analog Scale, VAS, Range from 1 (no pain) to 10 (strongest pain)) (27) at every study visit (except visit 1: preop. assessment) | 12 months | 
| ROM | Clinical reassessment at Routine follow-ups at every study visit - An Arc >100° shows a good functional result, arc 50-100° is a fair (acceptable) result, arc <50° shows a poor (unsatisfactory) result, according to the Mayo elbow performance index (see appendix). | 12 months | 
| Woundhealing | Clinical reassessment at Routine follow-ups at every study visit - Classification in normal or delayed/impaired. Signs for im-pairment are local secretion, swelling, reddening or wound dehiscence. | 12 months | 
| Clinical fracture consolidation after one year | Clinical reassessment at Routine follow-ups at every study visit - Clinical signs for good consolidation are: no pain while palpating the fracture site. | 12 months |