MagnezixKids Study

Not Applicable

Completed

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

• Registration Number: NCT04571905
• Lead Sponsor: Thomas Krebs

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-01
• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-09-25
• Study First Posted: 2020-10-01
• Primary Completion: 2023-07-12
• Study Completion: 2023-07-12
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-05
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Clinical and radiologic outcome (fracture consolidation)	12 months	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).

Secondary Outcome Measures

Name	Time	Method
ROM	12 months	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).
Woundhealing	12 months	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.
Clinical fracture consolidation after one year	12 months	Clinical reassessment at Routine follow-ups at every study visit; - Clinical signs for good consolidation are: no pain while palpating the fracture site.
Analgesic reuirement	12 months	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)

Trial Locations

Locations (1)

Childres Hospital of Eastern Switzerland; 🇨🇭 Saint Gallen, Switzerland